Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Curative Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes: Dose Escalation Trial
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.
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