Erectile Dysfunction Associated With Type 2 Diabetes MellitusPhase 1NCT02945449
Safety of Wharton Jelly in Erectile Dysfunction
A Phase 1 study testing Wharton Jelly Mesenchymal stem cells in people with Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by Sophia Al-Adwan at 1 site in Jordan.
Trial summary
Safety of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients. Read more about this study
- Who is it for?
- Ages 25 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
- What is being tested?
- Wharton Jelly Mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteJordan
- Study dates
- 4 Jan 2017to Nov 2018
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male patients ranging from 25 to 70 years.
- History of chronic erectile dysfunction for at least six months.
- Baseline international index of erectile function (IIEF) score of < 26.
- Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy and willing to forgo theses 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
- Current urinary tract or bladder infection.
- Clinical/Laboratory evidence of transmissible diseases.
- 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.
- Use of any non study treatment for erectile function within 4 weeks of study treatment.
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- 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 (CBC), prothrombin time (PT)/ partial thromboplastin time (PTT)/ international normalized ratio (INR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine falling outside the normal lab values.
- Systemic autoimmune disorder.
- Significant active systemic or localized infection.
- Receiving immunosuppressant medications.
- Post-radical prostatectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib: Evaluation of the Safety and as a Secondary End Point the Efficacy for Two Doses of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction
Safety of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.
Read the detailed description
This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which nine male patients ranging from 25-70 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.
The patients are followed by clinical assessment, laboratory investigations as well as Doppler ultrasound.
- Being tested
- Wharton Jelly Mesenchymal stem cells
- Keywords
- Wharton jelly mesenchymal stem cells, Erectile Dysfunction, Diabetes, safety
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wharton Jelly Mesenchymal stem cellsBiological
Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Dose I | Experimental | Dose I of Wharton Jelly Mesenchymal stem cells (WJ-MSC) Two intracavernous injections of 20 million of WJ-MSC cells will be given to erectile dysfunction patients at baseline and 4th week of follow up. Receives: Biological: Wharton Jelly 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]
Patients will be assessed for any relevant adverse event resulting from the intracavernous injection of the Wharton jelly mesenchymal stem cells.
Measured: 6 months
Secondary outcomes (1)
Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaire
Patients will be evaluated for the efficacy of the intracavernous injection of Wharton Jelly derived Mesenchymal Stem Cells by Sexual Health Inventory for Men/International Index of Erectile Function/Erection Hardness Score (SHIM/IIEF/EHS) questionnaire.
Measured: 12 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 start4 Jan 2017
- Primary completion15 Oct 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Associated With Type 2 Diabetes MellitusStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophia Al-Adwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sophia Al-Adwan, University of Jordan
- Investigators
- Abdallah Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945449
- Sponsor's protocol ID
- WJ.EDUJCTC
- Status last verified
- Nov 2018
- First submitted
- 17 Oct 2016
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib: Evaluation of the Safety and as a Secondary End Point the Efficacy for Two Doses of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02945449
- Acronym / sponsor ID
- WJ.EDUJCTC
- Keywords
- Wharton jelly mesenchymal stem cells, Erectile Dysfunction, Diabetes, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sophia Al-AdwanUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- Nov 2018 (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.
Safety of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.
Detailed description
This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which nine male patients ranging from 25-70 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.
The patients are followed by clinical assessment, laboratory investigations as well as Doppler ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose I | Experimental | Biological: Wharton Jelly Mesenchymal stem cellsDose I of Wharton Jelly Mesenchymal stem cells (WJ-MSC) Two intracavernous injections of 20 million of WJ-MSC cells will be given to erectile dysfunction patients at baseline and 4th week of follow up. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male patients ranging from 25 to 70 years.
- History of chronic erectile dysfunction for at least six months.
- Baseline international index of erectile function (IIEF) score of < 26.
- Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment.
- Body Mass Index between 20-30.
Key exclusion criteria (16 listed)
- Current urinary tract or bladder infection.
- Clinical/Laboratory evidence of transmissible diseases.
- 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.
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 |
|---|---|---|
| Wharton Jelly Mesenchymal stem cellsIntracavernous injection of Wharton Jelly Mesenchymal stem cells. | Biological | Dose I |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 6 months
Patients will be assessed for any relevant adverse event resulting from the intracavernous injection of the Wharton jelly mesenchymal stem cells.
1 secondary outcome
Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaire
Time frame: 12 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 15 Nov 2018.
- 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.
Abdallah Awidi, MD study director
Cell Therapy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wharton Jelly Mesenchymal stem cells in people with Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by Sophia Al-Adwan at 1 site in 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 6 inclusion and 16 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 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 6 months). 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 15 Nov 2018.