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Clinical Trial Details

Trial ID: L1924
Source ID: NCT03361631
Associated Drug: Autologous Bone Marrow Derived Mesenchymal Stem Cells
Title: Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes
Acronym: MESERIC
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Erectile Dysfunction|Stem Cells|Diabetes Mellitus, Type 1
Interventions: DRUG: Autologous Bone Marrow derived Mesenchymal Stem Cells
Outcome Measures: Primary: 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., 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, within 2 weeks after the injection of CSMa | Secondary: 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), Simplified Scale IIEF-5 with 5 questions (total score between 1 to 25), 12 and 24 weeks after injection|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 feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples, 19 months|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
Sponsor/Collaborators: Sponsor: Central Hospital, Nancy, France
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-06-30
Completion Date: 2019-12-31
Results First Posted:
Last Update Posted: 2017-12-05
Locations:
URL: https://clinicaltrials.gov/show/NCT03361631