Stem Cell Secretome for the Treatment of Erectile Dysfunction

Stem cell therapy for erectile dysfunction has become an active area of scientific research. This article summarizes what published research has reported so far, explains the scientific rationale behind the stem cell secretome, and describes the treatment approach ANOVA applies at its clinic in Germany.

Erectile dysfunction (ED) is defined as the consistent or current inability to achieve and/or maintain an erection sufficient for satisfactory sexual performance.

ED is highly prevalent; its rates range from 10 to 50% for men of 40 to 70 years of age¹. Risk factors for ED include hypertension, hyperlipidemia, diabetes, smoking, obesity, ß-blockers, anti-depressants, and alcohol use, amongst others².

There are many different causes that can lead to ED. We published an article on the causes of ED previously.

Pharmacologically approved treatments for ED generally address the symptoms rather than the underlying cause of ED¹, and a proportion of patients do not respond adequately to them³. This has motivated scientific interest in approaches that aim at the underlying tissue and vascular changes.

More than forty preclinical (animal-model) studies have reported beneficial effects of bone marrow- and adipose-derived stem cells in nerve-injury-, aging- and diabetes mellitus-related ED³.

Early clinical studies in patients have since reported encouraging findings¹: improvements in penile hardness in men with type 2 diabetes mellitus-related ED, the ability to achieve intercourse together with better IIEF-5 scores in continent patients after radical prostatectomy, and increases in penile artery peak systolic velocity. IIEF-5 stands for International Index of Erectile Function and is a standard questionnaire that tracks sexual function in men. Changes in the Erection Hardness Score (EHS) were also reported, with or without the concomitant use of PDE-5 inhibitors. These early clinical findings come from small studies and require further evaluation, but together with the preclinical data they provide a scientific rationale for the approach.

How stem cells produce these effects is not yet fully established. Current evidence suggests that they act largely through a local paracrine mechanism — that is, through the factors they secrete rather than through the cells themselves¹. This observation is central to the rationale for secretome-based approaches.

In one clinical study, an initial improvement declined over time, which suggests that repeated applications may be needed to maintain an effect¹. Informed by these findings, ANOVA uses a treatment scheme of repeated applications — where appropriate, in series of three to five applications repeated every few months.

ANOVA applies secretome therapy in selected patients following an individual medical assessment. A typical scheme combines intravenous and intracavernous applications of Mesenchymal stem cell (MSC) Secretome.

For example, a total of 5 intravenous and 5 intracavernous applications may be given in two treatment blocks a few months apart, each block delivered over the course of three days, as shown in the figure.

In ANOVA's clinical experience, some patients have reported changes in sexual function following treatment. Individual experiences of this kind vary from person to person and are not a substitute for controlled clinical data, but they are broadly consistent with the findings reported in the scientific literature.