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

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ClinicalTrials.gov Identifier: NCT03361631
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Tracking Information
First Submitted Date  ICMJE November 22, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date December 5, 2017
Estimated Study Start Date  ICMJE June 30, 2018
Estimated Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
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. [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
  • 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) [ Time Frame: 12 and 24 weeks after injection ]
    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 [ Time Frame: 12 and 24 weeks after injection ]
  • 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 ]
  • 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 ]
  • Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the number of bone marrow extraction [ Time Frame: 19 months ]
  • Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples [ Time Frame: 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 [ Time Frame: 19 months ]
  • Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the cell transport delay (between preparation and injection) [ Time Frame: 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 [ Time Frame: 19 months ]
  • Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the Injection rate actually achieved [ Time Frame: 19 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Erectile Dysfunction
  • Stem Cells
  • Diabetes Mellitus, Type 1
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: arm treated with MSC
  • 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: Drug: Autologous Bone Marrow derived Mesenchymal Stem Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2017)
13
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rabih EL OSTA, MD 03.83.15.33.78 ext +33 r.elosta@chru-nancy.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03361631
Other Study ID Numbers  ICMJE PHRCI2016/MESERIC-EL OSTA/NK
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Central Hospital, Nancy, France
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP