Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes (MESERIC)
Primary Purpose
Erectile Dysfunction, Stem Cells, Diabetes Mellitus, Type 1
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Autologous Bone Marrow derived Mesenchymal Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
arm treated with MSC
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of the EHS score
Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of arterial insufficiency
Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of venous insufficiency (venous leakage)
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the number of bone marrow extraction
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the cell culture of the marrow of diabetic patients
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the cell transport delay (between preparation and injection)
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
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the Injection rate actually achieved
Full Information
NCT ID
NCT03361631
First Posted
November 22, 2017
Last Updated
November 28, 2017
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03361631
Brief 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
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2018 (Anticipated)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Stem Cells, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
arm treated with MSC
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Autologous Bone Marrow derived Mesenchymal Stem Cells
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
within 2 weeks after the injection of CSMa
Secondary Outcome Measure Information:
Title
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)
Description
Simplified Scale IIEF-5 with 5 questions (total score between 1 to 25)
Time Frame
12 and 24 weeks after injection
Title
Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of the EHS score
Time Frame
12 and 24 weeks after injection
Title
Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of arterial insufficiency
Time Frame
12 and 24 weeks after injection
Title
Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of venous insufficiency (venous leakage)
Time Frame
12 and 24 weeks after injection
Title
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the number of bone marrow extraction
Time Frame
19 months
Title
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples
Time Frame
19 months
Title
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the cell culture of the marrow of diabetic patients
Time Frame
19 months
Title
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the cell transport delay (between preparation and injection)
Time Frame
19 months
Title
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
Time Frame
19 months
Title
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the Injection rate actually achieved
Time Frame
19 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabih EL OSTA, MD
Phone
03.83.15.33.78
Ext
+33
Email
r.elosta@chru-nancy.fr
12. IPD Sharing Statement
Learn more about this trial
Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes
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