Clinical trial NCT03361631: Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Erectile Dysfunction
Stem Cells
Diabetes Mellitus, Type 1
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: To evaluate the occurrence of clinical adverse event (tolerance) to intracavernous injection of autologous MSC in patients 18 to 50 years of age with complicated type 1 diabetes mellitus with erectile dysfunction refractory to oral treatment.
timeFrame: within 2 weeks after the injection of CSMa
Secondary outcomes:
measure: Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of the clinical score IIEF-5 (International Index of Erectile Function-5)
timeFrame: 12 and 24 weeks after injection
measure: Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of the EHS score
timeFrame: 12 and 24 weeks after injection
measure: Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of arterial insufficiency
timeFrame: 12 and 24 weeks after injection
measure: Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of venous insufficiency (venous leakage)
timeFrame: 12 and 24 weeks after injection
measure: Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the number of bone marrow extraction
timeFrame: 19 months
measure: Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples
timeFrame: 19 months
measure: Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the cell culture of the marrow of diabetic patients
timeFrame: 19 months
measure: Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the cell transport delay (between preparation and injection)
timeFrame: 19 months
measure: Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the patient recruitment rate calculated by the ratio between the number of participants and the number of eligible patients
timeFrame: 19 months
measure: Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the Injection rate actually achieved
timeFrame: 19 months
Other outcomes:
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