Using stem cells to treat Peyronie's disease, erectile dysfunction, and interstitial cystitis
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Peyronie's Disease, Erectile Dysfunction, and Interstitial Cystitis
This study is testing if stem cells from umbilical cords can safely help people with Peyronie's disease, erectile dysfunction, and interstitial cystitis feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 1 site (St John's) |
| Trial ID | NCT05147779 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of cultured allogeneic adult umbilical cord-derived mesenchymal stem cells (UC-MSCs) delivered either intravenously or through intracavernosal or interstitial methods for treating Peyronie's disease, erectile dysfunction, and interstitial cystitis. Patients will receive a total dose of 100 million cells and will be monitored for safety and efficacy at multiple time points over a period of 48 months. The study is patient-funded and aims to provide insights into the potential therapeutic benefits of stem cell treatment for these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Peyronie's disease, erectile dysfunction, or interstitial cystitis who are willing to provide informed consent.
Not a fit: Patients with active infections, cancer, chronic organ failure, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel and effective option for patients suffering from Peyronie's disease, erectile dysfunction, and interstitial cystitis.
How similar studies have performed: While the use of stem cells in treating these conditions is an emerging field, similar studies have shown promise, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Peyronie's Disease, erectile dysfunction, or Interstitial Cystitis * Understanding and willingness to sign a written informed consent document Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety. * Continued drug abuse * Pre-menopausal women not using contraception * Previous organ transplant * Hypersensitivity to sulfur
Where this trial is running
St John's
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.