Stem cell secretome therapy for type 1 and type 2 diabetes at ANOVA IRM in Offenbach, Germany.
 

Translational Medicine — Works in Progress

The ANOVA Diabetes Stem Cell Secretome
Treatment Programme Germany

Autologous, adipose tissue-derived MSC secretome (MSEC) therapy for people living with type 1 diabetes (T1D) or type 2 diabetes (T2D), together known as diabetes mellitus. Offenbach, Germany. Experimental — fully legal — manufactured under German regulatory authorisation and official inspection since 2018.

You have tried a lot. Perhaps you have been told there is nothing more to be done. We listen first, examine thoroughly, and then tell you honestly whether a stem cell-based therapy, one of our programmes or another option could be right for you. Each option is discussed as an addition to your current treatment, never as a replacement.

Request a Consultation →

ComponentDetail
Two products Bone Marrow Concentrate (BMC) and Mesenchymal Stem Cell Secretome (MSEC), each manufactured under official authorisation; no marketing authorisation (experimental)
Authorisations BMC § 20b / § 13 AMG · MSEC § 20b / § 20c AMG (German Medicines Act)
Location Offenbach am Main, Germany
Portrait of Dr. med. Dr. phil. Dr. med. habil. Michael K. Stehling, founder and medical director of ANOVA IRM.
Author and medically reviewed by

Dr. med. Dr. phil. Dr. med. habil. Michael K. Stehling

Dr. Stehling is a physicist and physician who was involved in the development of Magnetic Resonance Imaging (MRI) with Nobel laureate Sir Peter Mansfield. He founded ANOVA IRM in Offenbach, Germany, where autologous mesenchymal stem cell secretome (MSEC) and bone marrow concentrate (BMC) are manufactured under German regulatory authorisation and official inspection.

Introduction & Summary

What is diabetes mellitus, in brief?

Diabetes mellitus is a long-term condition in which the level of sugar (glucose) in the blood is too high. The hormone insulin, made by the beta cells in the islets of the pancreas, normally lets glucose enter the body’s cells. Doctors distinguish two main forms. In type 1 diabetes (T1D), the immune system destroys the beta cells, so the body makes little or no insulin.[7] In type 2 diabetes (T2D), muscle, liver and fat respond poorly to insulin, and the beta cells cannot keep up.[8] In Germany, about 95 in 100 people with diabetes have type 2.[5]

The diagnosis rests on blood tests. Diabetes is present with an HbA1c of 6.5% (48 mmol/mol) or more, or a fasting plasma glucose of 126 mg/dl (7.0 mmol/l) or more. A third option is a glucose of 200 mg/dl (11.1 mmol/l) or more two hours after a glucose drink.[1] Antibodies against the islet cells and the C-peptide level, which shows how much insulin the body still makes, help to tell the forms apart. To date no cure is known for type 1 diabetes; type 2 diabetes can go into remission after major weight loss, but it can come back.[19]

Common symptoms of high blood sugar include strong thirst, frequent urination, tiredness, blurred vision and, mainly in type 1 diabetes, unintended weight loss. Many people with type 2 diabetes have no symptoms for years.

More details can be found below in our scientific section on diabetes.

What is the ANOVA diabetes (T1D/T2D) programme?

ANOVA offers autologous MSC secretome (MSEC) for adults with type 1 or type 2 diabetes, in addition to the treatment their diabetologist prescribes. The programme consists of repeated infusions of MSEC into a vein, planned individually for each patient; it is not a fixed package.

Stem cells are thought to act mainly through soluble factors, together called the secretome, which includes exosomes and many other factors. In type 1 diabetes, an immune reaction against the beta cells continues for years.[7] In type 2 diabetes, a low-grade inflammation in fat tissue, liver and islets contributes to insulin resistance and to the loss of beta cells.[10] MSEC is intended to potentially influence this immune activity and inflammation; it is not intended to replace insulin-producing cells that have been lost.

ANOVA IRM has not yet tested MSEC in a clinical study. The current state of research is described in the clinical and scientific section below.

Programme — MSC secretome therapy for type 1 and type 2 diabetes at ANOVA IRM, Germany: mesenchymal stem cell secretome and exosomes.
MSC secretome and exosomes — the basis of MSEC therapy.

The ANOVA Diabetes (T1D/T2D) Programme — Components

01

MSC secretome (MSEC)

MSEC is the cell-free mixture of signalling molecules released by your own mesenchymal stromal cells from fat tissue, given as an infusion into a vein. External laboratory and animal studies suggest that such factors may dampen the immune attack on the islets and improve the response to insulin in models of diabetes.[35],[36] Small external clinical studies with mesenchymal stem cells — cells, not secretome — are summarised in the clinical and scientific section below.

Insulin, other diabetes medication, diabetes education and the screening for complications are not part of our programme; they continue with your diabetologist and GP at home.

Which diagnostics do we use for diabetes at ANOVA IRM?

Which tests are used to diagnose diabetes?

Diabetes is diagnosed by blood tests: HbA1c, fasting plasma glucose or an oral glucose tolerance test, repeated to confirm the result unless the diagnosis is clear.[1] Antibodies against islet cells, such as GAD65, IA-2 and ZnT8, point to type 1 diabetes and can be found years before symptoms begin.[6] C-peptide shows how much insulin the body still produces. Further tests look for complications, such as the urine albumin test, an eye examination and a check of the nerves in the feet.

What do we review before diabetes treatment at ANOVA IRM?

Before any treatment decision we review the type and duration of your diabetes, your HbA1c over the last year, any C-peptide and antibody results, and your current insulin or other medication. We ask about severe low blood sugar episodes and ketoacidosis, check your kidney function and heart, and check that you are fit for the brief sedation required for tissue collection.

  • Standard: an MRI of the abdominal wall to exclude a hernia is required before the liposuction, taken no more than four weeks beforehand. It can be done at home or at ANOVA IRM.
  • Optional: further MRI scans, with or without contrast, where your diabetes situation calls for them — for example, imaging of the pancreas.

Imaging can be carried out in-house; all examinations can also be done by your own doctors. The full diagnostic pathway is described on our diagnostics page.

Diagnostics — MSC secretome therapy for type 1 and type 2 diabetes at ANOVA IRM, Germany: MRI scanner for imaging before the tissue collection.
MRI scanner. © Siemens Healthcare GmbH.

Why ANOVA IRM for diabetes?

ANOVA IRM has made MSEC in its own facility in Offenbach since 2018 (see our regulatory status). The infusions are given under medical supervision in Offenbach. Your diabetologist and GP remain the basis of your care.

What can you expect as a patient with diabetes?

The first assessment can take place remotely, by phone or video, before any journey to Germany. Treatment itself takes place in person in Offenbach am Main, less than 20 minutes from Frankfurt Airport. Before you decide, you receive an individual written cost estimate; the services of our patient care team are free of charge. If you would like existing findings assessed independently, we also offer a second opinion.

Quick answers

Is there a cure for diabetes?

No. Type 1 diabetes cannot be cured, and type 2 diabetes can at best go into remission after major weight loss;[19] standard treatment with insulin and other medicines keeps blood sugar in range. Experimental approaches are being explored, including mesenchymal stem cell-based therapies[30] and stem cell-derived islet cells;[41] ANOVA IRM offers MSC secretome (MSEC).

Can stem cell therapy cure type 1 or type 2 diabetes?

No. Stem cell therapy is not a cure for type 1 or type 2 diabetes. The use of MSEC at ANOVA IRM aims to influence immune activity and inflammation, and it is given alongside insulin and your other diabetes medication, never instead of them.

Yes, provided the manufacturer holds the official authorisations for its product. For people with diabetes, ANOVA IRM produces MSEC under a collection (procurement) authorisation (Section 20b AMG) and a manufacturing authorisation under Section 20c AMG. These were granted by the Darmstadt Regional Council, today the Hessian State Office for Health and Care (HLfGP), with the involvement of the Paul-Ehrlich-Institut; the HLfGP inspects the facility regularly. MSEC is given as an individual therapeutic attempt (individueller Heilversuch); the legal basis is set out on our regulatory status page.

Is diabetes stem cell therapy safe?

Not without qualification. The fat collection, the brief sedation and the infusion carry general risks, which your doctor explains before treatment. If your insulin or other diabetes medication is changed during the treatment period, low blood sugar (hypoglycaemia) can occur. Any change must be made with your treating physician and needs close glucose monitoring.

Manufacturing under an official authorisation adds a layer of safety. The competent authority inspects the facility every two years, and every change to the process and every new material must be reported to it. Providers without an authorisation are not subject to this control.

Dr. mult. Stehling and ANOVA IRM have made MSEC with the same process since 2016, under an authorisation according to Section 20c AMG since 2018, and have treated 355 people with it (as of October 2026). To date, no serious adverse event has been caused by the product. Long-term data are not yet available. Safety is first examined in phase 1/2 studies with roughly 10 to 100 patients; ANOVA IRM has not run such a study, but has treated well above that number. Ask every provider for its authorisations; what regulators warn about is summarised under unproven therapies.

What medication is used for diabetes?

People with type 1 diabetes need insulin, given by injection or an insulin pump, often guided by a glucose sensor.[14] In type 2 diabetes, metformin, SGLT2 inhibitors and GLP-1 receptor agonists are widely used; the last two also lower the risk of heart and kidney disease. Insulin is added when these are not enough.[12],[13] MSC secretome (MSEC) at ANOVA IRM is added to this treatment and does not replace it.

Diabetes (T1D/T2D) Treatment: Eligibility, Process & Cost

In this section you will find everything about treatment for type 1 diabetes (T1D) and type 2 diabetes (T2D) at ANOVA IRM: who is eligible, the process step by step and the cost.

What does the diabetes treatment timeline look like?

  1. 01
    Initial evaluation

    Remote, by phone or video — typically 2 weeks to a few months

  2. 02
    Preliminary screening

    In your home country, to avoid an unnecessary journey

  3. 03
    First visit — bloodwork and tissue collection

    Two-day outpatient visit to Offenbach: bloodwork first, then — if the results are in order — mini-liposuction under brief sedation

  4. 04
    Production and quality control

    Approximately 4 weeks; yields 10 doses

  5. 05
    Storage

    Up to 2 years, allowing an extended personalised schedule

  6. 06
    Application schedule

    Set individually: one dose every 4–6 weeks, or two doses every 3 months

Who qualifies for diabetes treatment, and what are the requirements?

We consider adults with any form of diabetes. This includes type 1 diabetes, even without measurable C-peptide, and type 2 diabetes regardless of its duration, HbA1c level or whether insulin is needed. Other forms, such as LADA, MODY or diabetes after a disease of the pancreas, may also be considered. Your diabetes should be stable, without the recent acute complications listed under the contraindications below. You need to be well enough for mini-liposuction under brief sedation and able to travel to Offenbach for repeated infusions. Every treatment recommendation follows a full clinical evaluation in which the treating physician weighs benefit and risk. Applying for an evaluation does not mean that treatment will be offered.

What are the contraindications for diabetes treatment?

Our treatments are experimental. We treat only people for whom, after medical assessment, we consider the benefit-risk balance to support treatment.

Applies to all ANOVA treatments:

  • Active cancer within the last two years
  • Under the age of legal majority
  • Pregnancy or breastfeeding
  • Active infectious disease (hepatitis A, B, C, HIV, syphilis or other)

Specific to diabetes:

  • Diabetic ketoacidosis or a hyperosmolar hyperglycaemic state within the last four weeks
  • A severe low blood sugar episode needing help from another person within the last three months
  • An infected foot ulcer
  • Unstable coronary heart disease, or a heart attack within the last six months
  • Kidney failure requiring dialysis

Diabetic complications such as retinopathy or neuropathy are not contraindications in themselves. Whether your insulin or blood-thinning medication needs to be adjusted for the fat collection is decided with your treating doctors; please never stop insulin on your own.

What does diabetes therapy at ANOVA IRM involve, step by step?

What screening is needed before you travel for diabetes treatment?

A preliminary screening in your home country helps you avoid an unnecessary journey. It usually consists of a blood test for HIV, hepatitis A, B or C, syphilis and other active infections. Together with your latest HbA1c, kidney values and medication list, it also shows early whether medical factors would rule out treatment.

What happens at your first visit to Offenbach for diabetes?

The first treatment visit takes about two days in Offenbach and is outpatient. On the first day, bloodwork is repeated at ANOVA IRM as German medical rules require, and the physician completes the final assessment, including your blood sugar control and fitness for sedation. If the results are in order, a small amount of abdominal fat tissue is collected the next day by mini-liposuction under brief sedation. Please bring your insulin, glucose meter or sensor and fast-acting sugar. The first secretome application usually follows four to six weeks later.

How is your MSEC for diabetes produced and quality-controlled?

In our own facility in Offenbach, mesenchymal stromal cells are isolated from the collected fat tissue and expanded. This takes place under official authorisation and officially inspected good professional practice (GFP, gute fachliche Praxis; similar to Good Tissue Practice, GTP, in the US, but more than GTP). From these cells we obtain your MSEC — the signalling molecules they release, not the living cells. Production and quality control take approximately four weeks and yield 10 doses per production cycle. Every patient batch is tested with methods validated according to the European Pharmacopoeia (Ph. Eur.) and GMP and released under a documented procedure. The released secretome is stored at −80 °C and keeps for up to two years.

How is MSEC applied for diabetes?

Diabetes is a chronic disease, and there is currently no cure. We therefore recommend a longer-term treatment using all 10 doses produced rather than a single application; see the timeline above.

The schedule is set individually for each patient, for example:

  • At the start: two doses.
  • If you live close by: a single MSEC dose every 4 to 6 weeks.
  • If you live further away: a double dose every 3 months.
  • Route for diabetes: always an intravenous infusion, under medical supervision in Offenbach. Diabetes affects the whole body; our hypothesis is that, given into a vein, the secretome reaches the pancreas, the liver, muscle and fat tissue via the bloodstream.

All doses must be used within the two-year shelf life of the stored MSEC; continuing after that requires a new tissue collection and production cycle. An infusion into a vein is an established, everyday procedure. Your diabetes medication is not changed without your treating physician.

What does diabetes treatment with MSEC cost?

MSEC treatment costs approximately €20,000–€36,000, depending on the number of doses (three to ten), and requires a two-day visit for tissue collection, followed by further visits. It is billed according to the German Medical Fee Schedule (GOÄ). The base package — the mini-liposuction and the first three MSEC doses — costs approximately €20,000; each further dose costs approximately €2,250. Because we recommend using all 10 doses over a longer period for a chronic disease such as diabetes, most treatment plans reach the upper end of this range.

A double liposuction can be recommended for a chronic condition: it yields 20 doses, which can be used over the current shelf life of two years from a single collection. The cost is correspondingly higher and is shown in your individual estimate.

Further examinations and your sedation preferences also affect the total, and you receive an individual written estimate before any treatment decision. Our blog post on treatment cost explains what drives the cost of stem cell treatment in general. Travel, accommodation and other personal expenses, including those of an accompanying person, are not included. MSEC treatment for diabetes is generally self-funded; you can still ask your insurer about possible reimbursement. All prices are subject to change.

Why does the cost of diabetes treatment vary?

All treatments at ANOVA IRM are billed according to the German Medical Fee Schedule (Gebührenordnung für Ärzte, GOÄ). For diabetes, MSEC is always given as an infusion into a vein, so the cost depends mainly on the number of doses and on whether a double liposuction is planned. Your written cost estimate shows the exact amount.

Frequently asked questions — eligibility, process and travel

How is MSEC administered for diabetes?

By intravenous infusion: in Offenbach, MSEC is given into a vein under medical supervision; no other route is used for diabetes. After two doses at the start, a single dose follows every 4 to 6 weeks if you live nearby, or a double dose every 3 months if you live further away.

Which types of diabetes may be considered for treatment?

All forms of diabetes in adults: type 1 and type 2 diabetes, and other forms such as LADA, MODY or diabetes after a disease of the pancreas. The forms are assessed differently. In type 1 diabetes, the physician considers how much insulin your body still makes (C-peptide), although measurable C-peptide is not required. In type 2 diabetes, what matters is how well your blood sugar responds to current treatment and whether complications are present. In all forms, MSEC is given in the same way.

How will I know whether diabetes treatment with MSEC is having an effect?

No response can be promised, and it is possible that nothing changes. Because the treatment is experimental, we do not work with an expected timeline of improvement. What we define in advance is what will be followed: glucose readings and time in range, your insulin dose, HbA1c and C-peptide, and the symptoms you report. These values come from your own doctors and are compared with those before the first application.

How long does the whole diabetes treatment process take?

About one and a half years from the first contact to the last dose. The remote assessment takes from about two weeks to several months, depending on how quickly your laboratory results and medical reports are available. The tissue collection in Offenbach takes about two days, followed by approximately four weeks of production and quality control. The infusions then extend over about a year and must be completed within the two-year shelf life of the stored MSEC.

Does health insurance cover diabetes stem cell therapy in Germany?

No. Health insurers do not ordinarily reimburse experimental MSEC treatment for diabetes, so you should plan to pay privately. Your insulin, other medication, glucose sensors and check-ups remain covered as usual; for MSEC you can ask your insurer directly about an individual decision.

Should I stop my current diabetes medication such as insulin, metformin or GLP-1 receptor agonists?

No. The programme complements guideline-based care. Please continue to work with your treating diabetologist or GP throughout.

Should I continue my existing diabetes treatment such as diabetes education and foot care?

Yes. Glucose monitoring, diet and physical activity, diabetes education, eye and foot check-ups continue as before. MSEC is added to this care, and nothing changes unless your treating physician recommends it.

How often do I need to travel to Germany for diabetes stem cell treatment?

If you live further away, usually about six times over about a year. The first trip of about two days is for bloodwork and tissue collection in Offenbach, less than 20 minutes from Frankfurt Airport. The further trips are for the infusions: two doses at the start, then a double dose every 3 months. If you live close by, you come more often, for a single dose every 4 to 6 weeks. The full sequence is described on the MSC secretome page. Please carry your insulin and sensors in your hand luggage.

What medical records should I send for a diabetes assessment?

Please send us your most recent documents; we will ask if we need anything else. Helpful are, for example, a recent report from your diabetologist and your HbA1c values from the last year. C-peptide and islet antibody results, if tested, and a download of your glucose sensor or pump also help. Kidney values, eye and foot examination reports and a current medication list complete the picture.

Does ANOVA IRM treat international patients with diabetes?

Yes. People with type 1 or type 2 diabetes from other countries can start from home: we advise in English and carry out the first assessment by phone or video.

Diabetes (T1D/T2D): Clinical & Scientific Evidence

What happens in the body in type 1 and type 2 diabetes (T1D/T2D)?

Diabetes mellitus is defined by raised blood glucose. The American Diabetes Association (ADA) classifies it into type 1 diabetes, caused by autoimmune destruction of the beta cells, type 2 diabetes, and other specific forms such as gestational diabetes or monogenic diabetes.[1] The diagnosis requires an HbA1c of at least 6.5%, a fasting plasma glucose of at least 126 mg/dl or a two-hour value of at least 200 mg/dl in the glucose tolerance test.[1]

Type 1 diabetes develops in stages. In stage 1, two or more islet antibodies are present while blood sugar is still normal; in stage 2, blood sugar is already abnormal without symptoms; stage 3 is the clinical diagnosis.[6] At diagnosis, part of the beta cells usually still works, and C-peptide falls over the following years.[7] In type 2 diabetes, insulin resistance comes first. An external autopsy study found a beta-cell volume 63% lower in obese and 41% lower in lean people with type 2 diabetes than in people without diabetes, with more cell death (apoptosis).[9]

Worldwide, about 589 million adults aged 20 to 79 had diabetes in 2024, more than four in ten of them undiagnosed; diabetes caused over 3.4 million deaths.[2] About 8.4 million people had type 1 diabetes in 2021, most of them adults.[4] In Germany, at least 9.3 million people have diagnosed diabetes; about 95% have type 2.[5]

What causes diabetes, and what are the risk factors?

Type 1 and type 2 diabetes have different causes. What causes diabetes and what keeps it going are two different questions; the next section deals with the second.

  • Type 1 — genes and the immune system: certain tissue types (HLA genes) increase the risk; a family history in parents or siblings raises it further.[7]
  • Type 1 — triggers: environmental factors such as viral infections are thought to start the immune reaction in susceptible people; the exact trigger is unknown.[7]
  • Type 2 — overweight and inactivity: excess body fat, especially in the abdomen and liver, and too little physical activity are the main modifiable risk factors.[8]
  • Type 2 — family history and age: the risk rises with age and if parents or siblings have type 2 diabetes.[8]
  • Type 2 — pregnancy: diabetes during pregnancy (gestational diabetes) raises the later risk for the mother.[1]

What drives the progression of diabetes?

In type 1 diabetes, T cells keep attacking the beta cells, and the remaining insulin production usually declines over the years after diagnosis.[7] Preserving it matters: in the external randomised DCCT trial, people who still produced some insulin had less retinopathy and nephropathy and, under intensive treatment, fewer severe low blood sugar episodes.[11]

In type 2 diabetes, a chronic low-grade inflammation in fat tissue, liver and islets contributes to insulin resistance and to beta-cell failure.[10] High blood sugar and excess fats further damage the beta cells, so many people need more medication over time.[8] Raised blood sugar over years damages small and large blood vessels.[15],[16] This is where our programme aims — at the immune activity and inflammation, not at the cause of diabetes, and not at a cure.

What is the guideline-based standard of care for diabetes?

In Germany, the S3 guideline of the German Diabetes Society describes the treatment of type 1 diabetes, and the National Disease Management Guideline (Nationale VersorgungsLeitlinie, NVL) that of type 2 diabetes. Internationally, the ADA updates its Standards of Care every year.[12],[13],[14] Good blood sugar control prevents complications. In the external randomised DCCT trial, intensive insulin treatment lowered the risk of developing retinopathy by 76%, at the cost of more frequent severe hypoglycaemia.[15] In the external randomised UKPDS trial, intensive treatment of type 2 diabetes reduced complications of the small blood vessels by 25%.[16]

Type 1 diabetes is treated with insulin, by several daily injections or a pump, increasingly guided by continuous glucose sensors and automated insulin delivery, and with structured education.[14] The antibody teplizumab can delay the onset of stage 3 type 1 diabetes in people at stage 2. In a small external phase 2 trial, the median time to diagnosis was 48.4 months with teplizumab and 24.4 months with placebo.[20] It has been authorised in the EU since January 2026.[21]

Type 2 diabetes is treated first with diet, physical activity and weight loss; in the external randomised DiRECT trial, 46% of participants were in remission after one year of intensive weight management.[19] Metformin is widely used. SGLT2 inhibitors and GLP-1 receptor agonists are preferred for people with heart or kidney disease: in the external phase 3 trials EMPA-REG OUTCOME and LEADER, they lowered major cardiovascular events by 14% and 13%.[12],[17],[18] Insulin is added when blood sugar remains too high. Blood pressure, lipids, kidneys, eyes and feet are treated and checked as well.[13]

These treatments control blood sugar and lower the risk of complications, but none of them restores beta cells that have been lost. Donor islet cells are approved in the US for a small group of adults, and stem cell-derived islet cells are being tested elsewhere; both require immunosuppression (see the FAQ below). MSEC does not replace standard care.

How is diabetes diagnosed, and what do we not do ourselves?

Diabetes is diagnosed and monitored by your diabetologist or GP, not by us. HbA1c, fasting plasma glucose and the oral glucose tolerance test (OGTT) confirm the diagnosis.[1] Islet antibodies (GAD65, IA-2, ZnT8, insulin autoantibodies) and C-peptide distinguish type 1 from type 2 and show how much insulin is still produced.[1],[6] Continuous glucose monitoring (CGM) shows time in range and low blood sugar episodes.

Screening for complications includes the urine albumin-to-creatinine ratio and the estimated glomerular filtration rate (eGFR) for the kidneys, and an eye examination for retinopathy. A foot examination with a monofilament checks for neuropathy, and blood pressure and lipids are measured.[1],[13]

What we do ourselves is imaging: MRI with or without contrast, carried out at the Prof. Dr. Stehling Institut für Bildgebende Diagnostik GmbH in the same building, which also belongs to Dr. Stehling. We do not perform the diabetes diagnosis itself or diabetes laboratory tests such as HbA1c, C-peptide or islet antibodies. Nor do we adjust your insulin or other medication or carry out eye examinations or complication screening; please bring these findings from your doctors.

What is the scientific rationale for MSEC in diabetes?

MSC secretome (MSEC)

ANOVA IRM has not yet tested MSEC in a clinical study. MSEC is a mesenchymal stromal cell secretome: the growth factors, cytokines (cell-to-cell messengers) and extracellular vesicles released by these cells, without the cells themselves. Mesenchymal stem cells and mesenchymal stromal cells are two names for the same cells (MSC); the International Society for Cell & Gene Therapy recommends “stromal” for cells grown in the laboratory.[33],[34] Most of their effects are thought to come from these released factors.[32]

In an external animal study in mice with diabetes resembling type 1, exosomes from fat-derived MSC shifted the immune response towards regulatory T cells and anti-inflammatory messengers, and more islets were found in the pancreas.[35] In an external rat study of type 2 diabetes, exosomes from umbilical cord MSC lowered blood sugar, partly reversed insulin resistance and reduced the death of beta cells.[36] An external review describes these effects as experimental and names open questions, including the use of cells from people who themselves have diabetes.[37]

This last point matters for an autologous product. In external laboratory studies, fat-derived stem cells from donors with obesity or type 2 diabetes showed weaker immune-suppressing activity and a more inflammatory profile, and high glucose reduced their growth.[38],[39] In an external mouse study of type 1 diabetes, MSC from donor animals reversed high blood sugar for a time, whereas the animals’ own MSC did not.[40] Whether this also applies to fat-derived secretome from people with diabetes is not known.

Scientific rationale — MSC secretome therapy for type 1 and type 2 diabetes at ANOVA IRM, Germany: secretome components and signalling.
MSC secretome components and cellular signalling.

In humans, mainly mesenchymal stem cells — cells, not secretome — have been tested. In a small external randomised but open study, 20 adults with newly diagnosed type 1 diabetes received their own bone marrow MSC or no cells. C-peptide was better preserved after one year, but a benefit on HbA1c or insulin dose could not yet be demonstrated.[22] In a small external randomised, double-blind phase 1/2 trial with donor umbilical cord MSC, C-peptide fell by about 10%, compared with about 47% with placebo; an effect on HbA1c could not yet be demonstrated. The trial was sponsored by the manufacturer.[23] In a further small external randomised phase 1/2 trial with the patients’ own MSC, a benefit on C-peptide or insulin dose could not yet be demonstrated compared with placebo.[24] In a small external study with donor fat-derived cells in seven people with recent type 1 diabetes, a difference from controls could not yet be demonstrated after correction for multiple testing.[25]

In type 2 diabetes, a small external randomised, double-blind phase 2 trial included 91 adults. The goal of HbA1c below 7% with half the insulin dose was reached by 20% with donor umbilical cord MSC and by 4.55% with placebo. An effect on beta-cell function could not yet be demonstrated.[26] A small external, manufacturer-sponsored trial with donor bone marrow precursor cells primarily examined safety; HbA1c fell only at the highest dose and only transiently.[27] A small external study with the patients’ own bone marrow cells reported lower insulin needs in 6 of 10 people.[28] An earlier external meta-analysis, which also included non-randomised studies, reported lower HbA1c and some people who no longer needed insulin, mainly in type 2 diabetes.[29] A more recent external meta-analysis of 13 randomised trials with 507 patients found lower HbA1c and insulin doses after one year, with marked differences between trials.[30] Another external meta-analysis of seven randomised trials in type 1 diabetes, with all kinds of stem cells, rated the certainty of the evidence as very low; no participant became insulin-independent.[31]

For secretome or extracellular vesicles in diabetes itself, no clinical results have yet been published to our knowledge. Registered external studies with vesicles from donor cells have not reported results. Stem cell-derived islet cells, which replace beta cells rather than act through signalling factors, are a different approach and are described in the FAQ below.[41],[42]

What is the efficacy hypothesis behind MSC secretome in diabetes?

In type 1 diabetes, T cells attack the beta cells, and in type 2 diabetes, chronic inflammation contributes to insulin resistance and beta-cell failure.[7],[10] The hypothesis is that the soluble factors of the mesenchymal stromal cell secretome, carried by the bloodstream, influence this immune activity. In animal models they may shift the immune response towards regulation, improve the response to insulin and reduce the death of beta cells.[35],[36],[37]

One limitation belongs with it: beta cells that have been lost are not expected to grow back. Our aim is to influence the immune activity and inflammation and to help preserve remaining insulin production, not to cure diabetes.

Talk to us about current changes or additions to the programme. For several conditions, ANOVA IRM also offers other infusion therapies alongside MSEC.

Request a Consultation →

Where does our own diabetes evidence stand?

We do not currently publish our own outcome data for diabetes. What we can say about MSEC in diabetes therefore rests on the published literature and on the rationale described above. Some patients describe their experience on our testimonials page; these are individual accounts, not evidence that a treatment works.

Stem cell-based therapy for diabetes remains experimental, and outcomes vary from patient to patient. Treatment goals are agreed individually and followed with the C-peptide, HbA1c, glucose sensor data and insulin dose recorded by your own doctors. Treatment cannot guarantee better blood sugar control, a lower insulin dose or independence from insulin.

What is the realistic goal of diabetes treatment?

Care for diabetes aims to keep blood sugar in a safe range, avoid severe low blood sugar and prevent complications.[12],[14] For MSEC, too, the aim is to influence immune activity and inflammation and to help preserve remaining insulin production, not to replace beta cells that have been lost.

MSEC is an autologous tissue preparation from the patient’s own fat tissue, which ANOVA IRM manufactures under a collection (procurement) authorisation (Section 20b AMG) and a manufacturing authorisation under Section 20c AMG. Both were granted by the Darmstadt Regional Council, today the Hessian State Office for Health and Care (HLfGP), with the involvement of the Paul-Ehrlich-Institut; the HLfGP inspects the facility regularly. For diabetes, MSEC is given as an individual therapeutic attempt (individueller Heilversuch), which concerns the administration only and follows full disclosure and informed consent. Because the product is used only for ANOVA IRM’s own patients, no authorisation under Section 4b(3) or Section 21a AMG is required (see our regulatory status page).

Frequently asked questions — diabetes, evidence and approval status

Is stem cell therapy approved for diabetes anywhere?

No. To our knowledge, no stem cell therapy is approved for type 1 or type 2 diabetes anywhere. The US list of approved cell and gene therapies contains one product for type 1 diabetes, but it consists of islet cells from deceased donors, not stem cells. It is approved for adults with repeated severe low blood sugar and requires lifelong immunosuppression.[43],[44] At ANOVA IRM, MSEC is given for diabetes as an individual therapeutic attempt.

Are MSC studies evidence that MSEC works in diabetes?

No. Animal studies and small external clinical studies with mesenchymal stem cells provide a rationale, but no proof. Some small external trials in type 1 diabetes reported better preserved C-peptide.[22],[23] In another small external randomised trial, this could not yet be demonstrated, and a meta-analysis rated the certainty of the evidence as very low.[24],[31] Proof would require a randomised controlled trial with MSEC itself, and none exists. See the scientific rationale.

What type of stem cell therapy does ANOVA use for diabetes?

ANOVA uses an autologous mesenchymal stem cell secretome (MSEC), produced from mesenchymal stromal cells taken from the patient’s own abdominal fat tissue. The preparation given into a vein is cell-free and contains no living cells.

Does ANOVA use embryonic or pluripotent stem cells or insulin-producing cells for diabetes?

No. For diabetes, as for all conditions, ANOVA IRM uses only adult cells from your own body as the starting material. We do not use embryonic stem cells, induced pluripotent stem cells, donor cells or insulin-producing cells grown in the laboratory. Such stem cell-derived islet cells are being tested elsewhere in small external studies. In one, 10 of 12 people with type 1 diabetes no longer needed insulin after one year; they required immunosuppression.[41],[42] These products are not approved.

How common is diabetes?

Very common. About 589 million adults aged 20 to 79 worldwide had diabetes in 2024, and the number is expected to rise to 853 million by 2050.[2] Another estimate, based on a broader age range, puts the number of adults with diabetes at 828 million in 2022.[3] About 8.4 million people worldwide had type 1 diabetes in 2021, about four in five of them adults.[4] In Germany, at least 9.3 million people have diagnosed diabetes. About 340,000 adults and about 35,000 children and adolescents have type 1 diabetes.[5]

What are the symptoms of diabetes?

The symptoms depend on how high the blood sugar is and how fast it rises. In type 1 diabetes they often appear within weeks; in type 2 diabetes they develop slowly or are absent for years.[1]

High blood sugar

  • strong thirst (polydipsia) and a dry mouth
  • frequent urination (polyuria), also at night
  • strong hunger (polyphagia)
  • unintended weight loss, mainly in type 1 diabetes

General symptoms

  • tiredness and weakness
  • blurred vision
  • slow-healing wounds and frequent infections

Signs of complications

  • numbness, tingling or burning in the feet (neuropathy)
  • nausea, vomiting, abdominal pain and rapid breathing in ketoacidosis — a medical emergency

Which forms of diabetes are there, and how does it progress?

Diabetes mellitus is divided into several forms by its cause; most people have type 2 diabetes.[1],[5]

  • Type 1 diabetes (T1D): autoimmune destruction of the beta cells; it can begin at any age, often in childhood or young adulthood. It develops in stages, from islet antibodies with normal blood sugar (stage 1) to the clinical disease (stage 3).[6]
  • Type 2 diabetes (T2D): insulin resistance with a gradual decline of insulin production; usually in adults and often linked to overweight. It can go into remission after major weight loss.[8],[19]
  • Other forms: diabetes in pregnancy (gestational diabetes), inherited forms (MODY), a slowly progressing autoimmune form in adults (LADA) and diabetes after diseases of the pancreas.[1]
  • Course: in type 1 diabetes, the remaining insulin production usually declines over the years after diagnosis; in type 2 diabetes, many people need more medication over time.[7],[8]

What complications can diabetes cause?

High blood sugar over years damages blood vessels and nerves, and several complications can be prevented or treated early.[1],[15],[16]

  • Acute: diabetic ketoacidosis, mainly in type 1 diabetes; a hyperosmolar hyperglycaemic state, mainly in type 2 diabetes; and severe low blood sugar as a side effect of treatment.
  • Eyes: damage to the retina (retinopathy), which can lead to loss of vision.
  • Kidneys: diabetic kidney disease (nephropathy), up to kidney failure.
  • Nerves: damage to the nerves (neuropathy), especially in the feet, and of the nerves to internal organs.
  • Heart and blood vessels: heart attack, stroke and narrowing of the leg arteries.
  • Feet: ulcers and infections that can lead to amputation (diabetic foot).

Affiliations of ANOVA

ANOVA IRM shares its premises in Offenbach with two further institutions owned by Dr. Stehling: the Institut für Bildgebende Diagnostik (IBDO), providing MRI and CT imaging, and the VITUS PRIVATKLINIK Prof. Dr. Stehling GmbH. Because imaging is carried out in the same building, the MRI required before the tissue collection for diabetes treatment can be performed in-house rather than referred elsewhere. See diagnostics at ANOVA IRM.

References — diabetes literature

Literature specific to diabetes is listed here. General literature on MSC, secretome and extracellular vesicles is maintained on the MSC secretome page, bone marrow literature on the BMC page.

Diabetes — definition, frequency, forms and course

  • [1] American Diabetes Association Professional Practice Committee. 2. Diagnosis and classification of diabetes: Standards of Care in Diabetes—2026. Diabetes Care. 2026;49(Suppl 1):S27–S49. doi:10.2337/dc26-S002. PMID: 41358893.
  • [2] International Diabetes Federation. IDF Diabetes Atlas. 11th ed. Brussels: International Diabetes Federation; 2025. Accessed 22 October 2026. https://diabetesatlas.org/
  • [3] NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes prevalence and treatment from 1990 to 2022: a pooled analysis of 1108 population-representative studies with 141 million participants. Lancet. 2024;404(10467):2077–2093. doi:10.1016/S0140-6736(24)02317-1. PMID: 39549716.
  • [4] Gregory GA, Robinson TIG, Linklater SE, et al. Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol. 2022;10(10):741–760. doi:10.1016/S2213-8587(22)00218-2. PMID: 36113507.
  • [5] Deutsche Diabetes Gesellschaft (DDG), diabetesDE – Deutsche Diabetes-Hilfe. Deutscher Gesundheitsbericht Diabetes 2026. Wiesbaden: MedTriX; 2025. Accessed 22 October 2026. https://www.diabetesde.org/system/files/document/Gesundheitsbericht%202026_final_0.pdf
  • [6] Insel RA, Dunne JL, Atkinson MA, et al. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015;38(10):1964–1974. doi:10.2337/dc15-1419. PMID: 26404926.
  • [7] Atkinson MA, Eisenbarth GS, Michels AW. Type 1 diabetes. Lancet. 2014;383(9911):69–82. doi:10.1016/S0140-6736(13)60591-7. PMID: 23890997.
  • [8] DeFronzo RA, Ferrannini E, Groop L, et al. Type 2 diabetes mellitus. Nat Rev Dis Primers. 2015;1:15019. doi:10.1038/nrdp.2015.19. PMID: 27189025.

Disease mechanisms

  • [9] Butler AE, Janson J, Bonner-Weir S, et al. Beta-cell deficit and increased beta-cell apoptosis in humans with type 2 diabetes. Diabetes. 2003;52(1):102–110. doi:10.2337/diabetes.52.1.102. PMID: 12502499.
  • [10] Donath MY, Shoelson SE. Type 2 diabetes as an inflammatory disease. Nat Rev Immunol. 2011;11(2):98–107. doi:10.1038/nri2925. PMID: 21233852.
  • [11] Steffes MW, Sibley S, Jackson M, et al. Beta-cell function and the development of diabetes-related complications in the Diabetes Control and Complications Trial. Diabetes Care. 2003;26(3):832–836. doi:10.2337/diacare.26.3.832. PMID: 12610045.

Standard of care

  • [12] American Diabetes Association Professional Practice Committee. 9. Pharmacologic approaches to glycemic treatment: Standards of Care in Diabetes—2026. Diabetes Care. 2026;49(Suppl 1):S183–S215. doi:10.2337/dc26-S009. PMID: 41358900.
  • [13] Bundesärztekammer (BÄK), Kassenärztliche Bundesvereinigung (KBV), Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationale VersorgungsLeitlinie Typ-2-Diabetes – Langfassung, Version 3.0. 2023. doi:10.6101/AZQ/000503. AWMF-Register-Nr. nvl-001. https://register.awmf.org/de/leitlinien/detail/nvl-001
  • [14] Deutsche Diabetes Gesellschaft (DDG). S3-Leitlinie Therapie des Typ-1-Diabetes, Version 5.1. 2023. AWMF-Register-Nr. 057-013. https://register.awmf.org/de/leitlinien/detail/057-013
  • [15] Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329(14):977–986. doi:10.1056/NEJM199309303291401. PMID: 8366922.
  • [16] UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352(9131):837–853. doi:10.1016/S0140-6736(98)07019-6. PMID: 9742976.
  • [17] Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–2128. doi:10.1056/NEJMoa1504720. PMID: 26378978.
  • [18] Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–322. doi:10.1056/NEJMoa1603827. PMID: 27295427.
  • [19] Lean MEJ, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018;391(10120):541–551. doi:10.1016/S0140-6736(17)33102-1. PMID: 29221645.
  • [20] Herold KC, Bundy BN, Long SA, et al. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019;381(7):603–613. doi:10.1056/NEJMoa1902226. PMID: 31180194.
  • [21] European Medicines Agency. Teizeild (teplizumab): EPAR — medicine overview. Authorised 8 January 2026. Accessed 22 October 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/teizeild

Mesenchymal stem cells in diabetes — clinical studies (cells, other products than MSEC)

  • [22] Carlsson PO, Schwarcz E, Korsgren O, et al. Preserved β-cell function in type 1 diabetes by mesenchymal stromal cells. Diabetes. 2015;64(2):587–592. doi:10.2337/db14-0656. PMID: 25204974.
  • [23] Carlsson PO, Espes D, Sisay S, et al. Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial. Diabetologia. 2023;66(8):1431–1441. doi:10.1007/s00125-023-05934-3. PMID: 37221247.
  • [24] Izadi M, Sadr Hashemi Nejad A, Moazenchi M, et al. Mesenchymal stem cell transplantation in newly diagnosed type-1 diabetes patients: a phase I/II randomized placebo-controlled clinical trial. Stem Cell Res Ther. 2022;13(1):264. doi:10.1186/s13287-022-02941-w. PMID: 35725652.
  • [25] Dantas JR, Araújo DB, Silva KR, et al. Adipose tissue-derived stromal/stem cells + cholecalciferol: a pilot study in recent-onset type 1 diabetes patients. Arch Endocrinol Metab. 2021;65(3):342–351. doi:10.20945/2359-3997000000368. PMID: 33939911.
  • [26] Zang L, Li Y, Hao H, et al. Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese adults with type 2 diabetes: a single-center, double-blinded, randomized, placebo-controlled phase II trial. Stem Cell Res Ther. 2022;13(1):180. doi:10.1186/s13287-022-02848-6. PMID: 35505375.
  • [27] Skyler JS, Fonseca VA, Segal KR, et al. Allogeneic mesenchymal precursor cells in type 2 diabetes: a randomized, placebo-controlled, dose-escalation safety and tolerability pilot study. Diabetes Care. 2015;38(9):1742–1749. doi:10.2337/dc14-2830. PMID: 26153271.
  • [28] Bhansali S, Dutta P, Kumar V, et al. Efficacy of autologous bone marrow-derived mesenchymal stem cell and mononuclear cell transplantation in type 2 diabetes mellitus: a randomized, placebo-controlled comparative study. Stem Cells Dev. 2017;26(7):471–481. doi:10.1089/scd.2016.0275. PMID: 28006991.
  • [29] Li Y, Wang F, Liang H, et al. Efficacy of mesenchymal stem cell transplantation therapy for type 1 and type 2 diabetes mellitus: a meta-analysis. Stem Cell Res Ther. 2021;12(1):273. doi:10.1186/s13287-021-02342-5. PMID: 33957998.
  • [30] Kashbour M, Abdelmalik A, Yassin MNA, et al. Mesenchymal stem cell-based therapy for type 1 & 2 diabetes mellitus patients: a systematic review and meta-analysis of randomized controlled trials. Diabetol Metab Syndr. 2025;17(1):189. doi:10.1186/s13098-025-01619-6. PMID: 40462158.
  • [31] Yadav J, Kumar J, Kumar R, et al. Efficacy and safety of stem cell therapy in type 1 diabetes: a systematic review and meta-analysis of randomised controlled trials. Indian J Med Res. 2026;164(1):81–90. doi:10.25259/IJMR_2655_2025. PMID: 42397823.

Mesenchymal stromal cell secretome and extracellular vesicles — laboratory and animal studies

  • [32] Galipeau J, Sensébé L. Mesenchymal stromal cells: clinical challenges and therapeutic opportunities. Cell Stem Cell. 2018;22(6):824–833. doi:10.1016/j.stem.2018.05.004. PMID: 29859173.
  • [33] Dominici M, Le Blanc K, Mueller I, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315–317. doi:10.1080/14653240600855905. PMID: 16923606.
  • [34] Viswanathan S, Shi Y, Galipeau J, et al. Mesenchymal stem versus stromal cells: International Society for Cell & Gene Therapy (ISCT®) Mesenchymal Stromal Cell committee position statement on nomenclature. Cytotherapy. 2019;21(10):1019–1024. doi:10.1016/j.jcyt.2019.08.002. PMID: 31526643.
  • [35] Nojehdehi S, Soudi S, Hesampour A, et al. Immunomodulatory effects of mesenchymal stem cell-derived exosomes on experimental type-1 autoimmune diabetes. J Cell Biochem. 2018;119(11):9433–9443. doi:10.1002/jcb.27260. PMID: 30074271.
  • [36] Sun Y, Shi H, Yin S, et al. Human mesenchymal stem cell derived exosomes alleviate type 2 diabetes mellitus by reversing peripheral insulin resistance and relieving β-cell destruction. ACS Nano. 2018;12(8):7613–7628. doi:10.1021/acsnano.7b07643. PMID: 30052036.
  • [37] Zeinhom A, Fadallah SA, Mahmoud M. Human mesenchymal stem/stromal cell based-therapy in diabetes mellitus: experimental and clinical perspectives. Stem Cell Res Ther. 2024;15(1):384. doi:10.1186/s13287-024-03974-z. PMID: 39468609.
  • [38] Serena C, Keiran N, Ceperuelo-Mallafre V, et al. Obesity and type 2 diabetes alters the immune properties of human adipose derived stem cells. Stem Cells. 2016;34(10):2559–2573. doi:10.1002/stem.2429. PMID: 27352919.
  • [39] Cramer C, Freisinger E, Jones RK, et al. Persistent high glucose concentrations alter the regenerative potential of mesenchymal stem cells. Stem Cells Dev. 2010;19(12):1875–1884. doi:10.1089/scd.2010.0009. PMID: 20380516.
  • [40] Fiorina P, Jurewicz M, Augello A, et al. Immunomodulatory function of bone marrow-derived mesenchymal stem cells in experimental autoimmune type 1 diabetes. J Immunol. 2009;183(2):993–1004. doi:10.4049/jimmunol.0900803. PMID: 19561093.

Stem cell-derived islet cells and approval status