Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

Diabetes is a major concern in public health because of its high frequency and its negative consequences. Erectile dysfunction (ED) is present, regardless of age, in 50 to 75% of men with diabetes. It is related to endothelial dysfunction and a decrease in smooth muscle and nerve cells. In type 1 diabetic patients, ED is part of the chronic complications of microangiopathy. Current therapies are exclusively symptomatic with moderate efficacy, estimated between 44 and 56%. The administration of culture-grown medullary mesenchymal stem cells (MSCs) would be a curative treatment and have the advantage of being single injection.

However, the data in the literature do not allow to define the optimal dose of MSC in this indication. In addition, the feasibility of this procedure is not known at present.

The aim of this study is to evaluate the tolerance and the efficacy of intracavernous injection of autologous MSC (bone marrow-derived MSCs) administered in a 4-dose-escalating design in patients from 18 to 50 years old with complicated type 1 diabetes mellitus and erectile dysfunction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France

Criteria

Inclusion Criteria:

• Type 1 diabetic man

• Aged from 18 to 50 years

• Having a diabetes evolving for at least 10 years

• Presenting at least one severe manifestation of microangiopathy, with or without dysautonomia: diabetic retinopathy, diabetic or vascular nephropathy, diabetic neuropathy, diabetic foot

• Presenting an erectile dysfunction refractory to oral treatment (sildenafil, tadalafil ...)

• IIEF-5 score less than or equal to 10

Exclusion Criteria:

• Any intercurrent event that does not allow the injection of aMSC

• Violation of the protocol by self erectile dysfunction medication

• Withdrawal of the protocol