Status:
UNKNOWN
Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Erectile Dysfunction
Stem Cells
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- Any intercurrent event that does not allow the injection of aMSC
- Violation of the protocol by self erectile dysfunction medication
- Withdrawal of the protocol
Key Trial Info
Start Date :
June 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03361631
Start Date
June 30 2018
End Date
December 31 2019
Last Update
December 5 2017
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