Erectile DysfunctionPhase 1MESERICNCT03361631
Intracavernous Injection of Autologous Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction Resistant to Oral Treatment in Patients With Type I Diabetes
A Phase 1 study testing Autologous Bone Marrow derived Mesenchymal Stem Cells in people with Erectile Dysfunction and Stem Cells, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Erectile Dysfunction, Stem Cells, Diabetes Mellitus, Type 1
- What is being tested?
- Autologous Bone Marrow derived Mesenchymal Stem Cells
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2018to 31 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Any intercurrent event that does not allow the injection of aMSC
- Violation of the protocol by self erectile dysfunction medication
- Withdrawal of the protocol
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Erectile Dysfunction, Stem Cells, Diabetes Mellitus, Type 1
- Being tested
- Autologous Bone Marrow derived Mesenchymal Stem Cells
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone Marrow derived Mesenchymal Stem CellsDrug
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 group | Role | What they receive |
|---|---|---|
| arm treated with MSC | Experimental | * 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 Receives: Drug: Autologous Bone Marrow derived Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 2 weeks after the injection of CSMa
Secondary outcomes (10)
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)
Measured: 12 and 24 weeks after injection
Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of the EHS score
Measured: 12 and 24 weeks after injection
Evaluation of the efficacy of autologous MSC intracavernous injections at different doses with evaluation of arterial insufficiency
Measured: 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)
Measured: 12 and 24 weeks after injection
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the number of bone marrow extraction
Measured: 19 months
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the quality of the bone marrow samples
Measured: 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
Measured: 19 months
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the cell transport delay (between preparation and injection)
Measured: 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
Measured: 19 months
Evaluation of the feasibility of the autologous MSC intracavernous injection protocol by the Injection rate actually achieved
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start30 Jun 2018 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361631
- Sponsor's protocol ID
- PHRCI2016/MESERIC-EL OSTA/NK
- Acronym
- MESERIC
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03361631
- Acronym / sponsor ID
- MESERIC / PHRCI2016/MESERIC-EL OSTA/NK
- Conditions
- Erectile Dysfunction, Stem Cells, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Jun 2018 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm treated with MSC | Experimental | Drug: Autologous Bone Marrow derived Mesenchymal Stem Cells* 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 ...)
Key exclusion criteria (3 listed)
- Any intercurrent event that does not allow the injection of aMSC
- Violation of the protocol by self erectile dysfunction medication
- Withdrawal of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Bone Marrow derived Mesenchymal Stem CellsInformation 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 | Drug | arm treated with MSC |
Primary outcome
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
10 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Bone Marrow derived Mesenchymal Stem Cells in people with Erectile Dysfunction and Stem Cells, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabih EL OSTA, MD (03.83.15.33.78 ext. +33, r.elosta@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.