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

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 1

Conditions: Diabetes Mellitus, Type 1; Erectile Dysfunction; Stem Cells

Treatments: Drug: Autologous Bone Marrow derived Mesenchymal Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03361631

PHRCI2016/MESERIC-EL OSTA/NK

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

arm treated with MSC

Experimental group

Description:

* 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

Treatment:

Drug: Autologous Bone Marrow derived Mesenchymal Stem Cells