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

Diabetes Mellitus, Type 1 Clinical Trial

— MESERIC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03361631
• Other study ID #: PHRCI2016/MESERIC-EL OSTA/NK
• Status: Not yet recruiting
• Phase: Phase 1
• First received: November 22, 2017
• Last updated: November 28, 2017
• Start date: June 30, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2017
• Source: Central Hospital, Nancy, France
• Contact: Rabih EL OSTA, MD
• Phone: 03.83.15.33.78
• Email: r.elosta[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 13
• Est. completion date: December 31, 2019
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Erectile Dysfunction
• Stem Cells

Intervention

Drug:
• Autologous Bone Marrow derived Mesenchymal Stem Cells
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of the EHS score		12 and 24 weeks after injection
Secondary	Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of arterial insufficiency		12 and 24 weeks after injection
Secondary	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
Secondary	Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the number of bone marrow extraction		19 months
Secondary	Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples		19 months
Secondary	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
Secondary	Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the cell transport delay (between preparation and injection)		19 months
Secondary	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
Secondary	Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the Injection rate actually achieved		19 months