RecruitingPhase 1NCT05003947

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Inflammatory Bowel Disease


Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Enrollment

15 participants

Start Date

Jun 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of inflammatory bowel disease


Eligibility

Inclusion Criteria2

  • Diagnosis of Crohn's disease or Ulcerative Colitis
  • 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(2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Center for Investigation in Tissue Engineering and Cellular Therapy

Buenos Aires, Argentina

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NCT05003947


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