Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial Cystitis
Study Details
Study Description
Brief Summary
This trial will study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Peyronie's disease, erectile dysfunction , and Interstitial Cystitis
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
This patient funded trial aims to study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Peyronie's disease, erectile dysfunction , and Interstitial Cystitis. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Treatment Group (AlloRx) intravenous and intracavernosal or interstitial delivery (total dose of 100 million cells) |
Biological: AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
|
Outcome Measures
Primary Outcome Measures
- Safety (adverse events) [Four year follow-up]
Clinical monitoring of possible adverse events or complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Peyronie's Disease, erectile dysfunction, or Interstitial Cystitis
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Understanding and willingness to sign a written informed consent document
Exclusion Criteria:
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Active infection
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Active cancer
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Chronic multisystem organ failure
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Pregnancy
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Clinically significant Abnormalities on pre-treatment laboratory evaluation
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Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
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Continued drug abuse
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Pre-menopausal women not using contraception
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Previous organ transplant
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Hypersensitivity to sulfur
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Medical Surgical Associates Center | St. John's | Antigua and Barbuda |
Sponsors and Collaborators
- The Foundation for Orthopaedics and Regenerative Medicine
Investigators
- Principal Investigator: Chadwick Prodromos, MD, The Foundation for Orthopaedics and Regenerative Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Al Demour S, Jafar H, Adwan S, AlSharif A, Alhawari H, Alrabadi A, Zayed A, Jaradat A, Awidi A. Safety and Potential Therapeutic Effect of Two Intracavernous Autologous Bone Marrow Derived Mesenchymal Stem Cells injections in Diabetic Patients with Erectile Dysfunction: An Open Label Phase I Clinical Trial. Urol Int. 2018;101(3):358-365. doi: 10.1159/000492120. Epub 2018 Aug 31.
- Bahk JY, Jung JH, Han H, Min SK, Lee YS. Treatment of diabetic impotence with umbilical cord blood stem cell intracavernosal transplant: preliminary report of 7 cases. Exp Clin Transplant. 2010 Jun;8(2):150-60.
- Levy JA, Marchand M, Iorio L, Zribi G, Zahalsky MP. Effects of Stem Cell Treatment in Human Patients With Peyronie Disease. J Am Osteopath Assoc. 2015 Oct;115(10):e8-13. doi: 10.7556/jaoa.2015.124.
- ATG-1-MSC-015