Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes
NCT ID: NCT03361631
Last Updated: 2017-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
13 participants
INTERVENTIONAL
2018-06-30
2019-12-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Violation of the protocol by self erectile dysfunction medication
* Withdrawal of the protocol
18 Years
50 Years
MALE
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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PHRCI2016/MESERIC-EL OSTA/NK
Identifier Type: -
Identifier Source: org_study_id