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

NCT03361631 | Unknown Phase 1

• 1 other identifier: PHRCI2016/MESERIC-EL OSTA/NK
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erectile Dysfunction; Stem Cells; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

Study Arms (1)

arm treated with MSC

EXPERIMENTAL

* 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

Drug: Autologous Bone Marrow derived Mesenchymal Stem Cells

Interventions

Autologous Bone Marrow derived Mesenchymal Stem Cells DRUG

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

arm treated with MSC

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any intercurrent event that does not allow the injection of aMSC
• Violation of the protocol by self erectile dysfunction medication
• Withdrawal of the protocol

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Rabih EL OSTA, MD

CONTACT

03.83.15.33.78; r.elosta@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 5, 2017
• Study Start: June 30, 2018
• Primary Completion: July 30, 2018
• Study Completion: December 31, 2019
• Last Updated: December 5, 2017

Record last verified: 2017-11