To investigate feasibility and safety of a new minimally invasive same-day method of autologous adipose derived stem cell (ADSC) transplantation in men suffering from ED.
Prospective case series of 10 men with an IIEF-EF domain score <17. The IIEF questionnaire was filled out at baseline and 1, 2 and 3 months after treatment. Side effects were assessed by investigations and interviews until 6 months after treatment. The myStem® X2 kit was used for preparation of ADSC: Adipose tissue was harvested from the patient himself under local anesthesia and immediately prepared and injected into the penis. Primary endpoints were feasibility and safety. Secondary outcomes included effects on ED and changes in the remaining IIEF domains.
Ten men were included. Only one adverse event in the form of minor blue discoloration at the fat harvest site was registered. There were statistically significant improvements in IIEF-EF at one, two and three months after treatment compared to baseline with the median score increasing from 5.5 to 10.5, 10.5 and 10, respectively. Considering the individual patients, 3/10 men achieved an improvement equal to or greater than the minimal clinically important difference according to their baseline IIEF-EF score.
Our study confirms the feasibility and safety of this minimally invasive, same-day delivery of ADSC. Due to the design and size on the study, conclusions should not be drawn regarding efficacy, but the method seems worthy of further study.