RecruitingPhase 1NCT05147779

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


Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Enrollment

20 participants

Start Date

Sep 12, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Inclusion Criteria2

  • Diagnosis of Peyronie's Disease, erectile dysfunction, or Interstitial Cystitis
  • Understanding and willingness to sign a written informed consent document

Exclusion Criteria10

  • 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

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Interventions

BIOLOGICALAlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells


Locations(1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

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NCT05147779


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