Diabetes Mellitus, Type 1, Erectile Dysfunction, Stem Cells
Conditions
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.
Interventions
Information visit (time 1) Inclusion visit (time 2) Bone marrow extraction (time 3) Treatment and culture of MSC (time 4) Intra-cavernosal injection of autologous MSC (time 5) Follow-up 1 (time 6): control / tolerance visit (andrological clinical examination, EHS and and IIEF-5), 2 weeks after injection; Follow-up 2 (time 7): 12-week evaluation of treatment response: andrological clinical examination, IIEF-5 and EHS score determination & Pharmaco-Doppler; Follow-up 3 (time 8): 24-week evaluation of the response to treatment: andrological clinical examination, determination of IIEF-5 and EHS scores & Pharmaco-Doppler
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | within 2 weeks after the injection of CSMa | Occurrence within 2 weeks after the injection of CSMa at the expected dose (10.106, 20.106, 30.106 and 40.106) of a clinical adverse event: thrombosis (s) of the cavernous body, subcutaneous hematoma, induration of the cavernous body , local inflammatory reaction (redness, pain), general effects: fever, chills |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of the EHS score | 12 and 24 weeks after injection | — |
| Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of arterial insufficiency | 12 and 24 weeks after injection | — |
| Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of venous insufficiency (venous leakage) | 12 and 24 weeks after injection | — |
| Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the number of bone marrow extraction | 19 months | — |
| 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) | 12 and 24 weeks after injection | Simplified Scale IIEF-5 with 5 questions (total score between 1 to 25) |
| Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the cell culture of the marrow of diabetic patients | 19 months | — |
| Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the cell transport delay (between preparation and injection) | 19 months | — |
| 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 | 19 months | — |
| Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the Injection rate actually achieved | 19 months | — |
| Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples | 19 months | — |
Contacts
Primary ContactRabih EL OSTA, MD
Outcome results
None listed