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Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05147779
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
The Foundation for Orthopaedics and Regenerative Medicine

Study Description
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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
Erectile Dysfunction Peyronie's Disease Interstitial Cystitis Biological: AlloRx 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Peyronie's Disease, Erectile Dysfunction, and Interstitial Cystitis
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: Four year follow-up ]
    Clinical monitoring of possible adverse events or complications


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147779


Locations
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Antigua and Barbuda
Medical Surgical Associates Center Recruiting
St. John's, Antigua and Barbuda
Contact: Chadwick Prodromos, M.D.    8476996810    research@ismoc.net   
Sponsors and Collaborators
The Foundation for Orthopaedics and Regenerative Medicine
Investigators
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Principal Investigator: Chadwick Prodromos, MD The Foundation for Orthopaedics and Regenerative Medicine
More Information
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Publications:

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Responsible Party: The Foundation for Orthopaedics and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT05147779    
Other Study ID Numbers: ATG-1-MSC-015
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by The Foundation for Orthopaedics and Regenerative Medicine:
Erectile Dysfunction
Peyronie's Disease
stem cell treatment
Interstitial Cystitis
Additional relevant MeSH terms:
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Erectile Dysfunction
Cystitis
Cystitis, Interstitial
Penile Induration
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
 Mental Disorders
Urinary Bladder Diseases
Urologic Diseases
Penile Diseases
Connective Tissue Diseases