Erectile DysfunctionPhase 1NCT02945462
Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
A Phase 1 study testing autologous mesenchymal stem cells in people with Erectile Dysfunction, run by University of Jordan.
Trial summary
Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- autologous mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Oct 2016
- 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 25 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male patients ranging from 25 to 65 years.
- Type 1 or type 2 diabetic patients with a personal history of diabetes ≥ 5 years.
- History of chronic erectile dysfunction for at least six months.
- HbA1c ≤ 10%.
- Baseline International Index of Erectile Function (IIEF) score of < 26.
- Not interested or able to use Phosphodiesterase type 5 inhibitor (PDE-5i) drug therapy and willing to forgo these treatments for the first 6 month period following study treatment.
- Body mass index between 20 -30.
- Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.
Who cannot join
- Untreated hypogonadism or low serum total testosterone < 200 ng/dl.
- Current urinary tract or bladder infection.
- Any medical evidence of any infectious disease.
- Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history of priapism.
- Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
- Current or previous malignancy.
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- Patients with primary hyperlipidemia.
- Use of any non study treatment for erectile dysfunction within 4 weeks of study treatment.
- Lack of willingness to continue through 6 months after study treatment.
- Any previous penile implant or penile vascular surgery.
- Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg, and diastolic blood pressure > 100 or < 50 mm Hg).
- Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening.
- Bleeding or clotting disorder, use of anticoagulant therapy.
- Lab values for complete blood count, prothrombin time/ partial thromboplastin time/international randomized ratio (PT/PTT/INR), Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine falling outside the normal lab values.
- Systemic autoimmune disorder.
- Significant active systemic or localized infection.
- Receiving immunosuppressant medications.
- HbA1c > 10%.
About this study
Official title: The Safety and Efficacy of Using Bone Marrow-derived Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction in Diabetic Patients
Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.
Read the detailed description
Four diabetic male patients ranging from 25-65 years diagnosed with erectile dysfunction will be selected. This diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests. Patients with any evidence of untreated hypogonadism, current urinary tract or bladder infection, clinically evident penile anatomical deformities, previous penile implant or penile vascular surgery, uncontrolled hypertension or hypotension, reported unstable Cardiovascular diseases, uncontrolled diabetes (HbA1c > 10%), or primary hyperlipidemia will be excluded. The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.
This study was performed:
- To test the safety of autologous intracavernous bone marrow mesenchymal stem cells.
- To evaluate benefit for the patient concerning recovery of natural erection by performing detailed and specific diagnostic tests prior and post MSCs injection by a team from Jordan University Hospital and Cell Therapy Center in Jordan University.
- To study the feasibility, indication criteria and application modalities of Bone marrow mesenchymal stem cells for further wider study.
- Conditions
- Erectile Dysfunction
- Being tested
- autologous mesenchymal stem cells
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous mesenchymal stem cellsBiological
Patients will be injected with autologous mesenchymal stem cells, intracavernously
| Study group | Role | What they receive |
|---|---|---|
| autologous mesenchymal stem cells | Experimental | Intervention:
Autologous bone marrow derived stem cells will be injected twice intracavernously to enrolled erectile dysfunction patients Receives: Biological: autologous mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Observation of any relevant adverse side effect resulting from the injection. Assessing the safety of autologous Mesenchymal Stem Cells injection
Measured: six months
Secondary outcomes (2)
Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Sexual Health Inventory for Men/ International Index for Erectile Function/ Erection Hardness Score (SHIM/IIEF/EHS) questionnaire.
For every patient tests would be performed at baseline and repeated at 1,3, 6,12, and 18 months post-injection.
Measured: 18 months
Evaluation the efficacy of intracavernous injection measured by Dynamic Infusion cavernosometry test.
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Dynamic Infusion Cavernosometry test at baseline and repeated at 6 months post injection.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saddam Dmour, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945462
- Sponsor's protocol ID
- EDUJCTC
- Status last verified
- Nov 2016
- First submitted
- 17 Oct 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Al Demour S, Adwan S, Jafar H, Alhawari H, Awidi A. Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial. Basic Clin Androl. 2024 Jul 5;34(1):13. doi: 10.1186/s12610-024-00229-y.
PubMed 38965462
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Using Bone Marrow-derived Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02945462
- Acronym / sponsor ID
- EDUJCTC
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.
Detailed description
Four diabetic male patients ranging from 25-65 years diagnosed with erectile dysfunction will be selected. This diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests. Patients with any evidence of untreated hypogonadism, current urinary tract or bladder infection, clinically evident penile anatomical deformities, previous penile implant or penile vascular surgery, uncontrolled hypertension or hypotension, reported unstable Cardiovascular diseases, uncontrolled diabetes (HbA1c > 10%), or primary hyperlipidemia will be excluded. The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.
This study was performed:
- To test the safety of autologous intracavernous bone marrow mesenchymal stem cells.
- To evaluate benefit for the patient concerning recovery of natural erection by performing detailed and specific diagnostic tests prior and post MSCs injection by a team from Jordan University Hospital and Cell Therapy Center in Jordan University.
- To study the feasibility, indication criteria and application modalities of Bone marrow mesenchymal stem cells for further wider study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous mesenchymal stem cells | Experimental | Biological: autologous mesenchymal stem cellsIntervention: Autologous bone marrow derived stem cells will be injected twice intracavernously to enrolled erectile dysfunction patients |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult male patients ranging from 25 to 65 years.
- Type 1 or type 2 diabetic patients with a personal history of diabetes ≥ 5 years.
- History of chronic erectile dysfunction for at least six months.
- HbA1c ≤ 10%.
- Baseline International Index of Erectile Function (IIEF) score of < 26.
Key exclusion criteria (18 listed)
- Untreated hypogonadism or low serum total testosterone < 200 ng/dl.
- Current urinary tract or bladder infection.
- Any medical evidence of any infectious disease.
- Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history of priapism.
- Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
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 mesenchymal stem cellsPatients will be injected with autologous mesenchymal stem cells, intracavernously | Biological | autologous mesenchymal stem cells |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: six months
Observation of any relevant adverse side effect resulting from the injection. Assessing the safety of autologous Mesenchymal Stem Cells injection
2 secondary outcomes
Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire
Time frame: 18 months
Evaluation the efficacy of intracavernous injection measured by Dynamic Infusion cavernosometry test.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Derived from this study: PubMed 38965462Al Demour S, Adwan S, Jafar H, Alhawari H, Awidi A. Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial. Basic Clin Androl. 2024 Jul 5;34(1):13. doi: 10.1186/s12610-024-00229-y.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous mesenchymal stem cells in people with Erectile Dysfunction, run by University of Jordan.
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 8 inclusion and 18 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: finished, as of the sponsor's last update on 16 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945462, which also lists 1 linked publication.
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 16 Nov 2016.