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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

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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Stem Cells Diabetes Mellitus, Type 1 Drug: Autologous Bone Marrow derived Mesenchymal Stem Cells Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 30, 2018
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  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. [ 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


Secondary Outcome Measures :
  1. 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)

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the number of bone marrow extraction [ Time Frame: 19 months ]
  6. Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples [ Time Frame: 19 months ]
  7. 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 ]
  8. Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the cell transport delay (between preparation and injection) [ Time Frame: 19 months ]
  9. 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 ]
  10. Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the Injection rate actually achieved [ Time Frame: 19 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361631


Contacts
Contact: Rabih EL OSTA, MD 03.83.15.33.78 ext +33 r.elosta@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03361631     History of Changes
Other Study ID Numbers: PHRCI2016/MESERIC-EL OSTA/NK
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Erectile Dysfunction
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Autoimmune Diseases
Immune System Diseases