RecruitingPhase 1NCT05147675

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for OA

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Osteoarthritis


Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Enrollment

92 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously and intraarticularly for the treatment of Osteoarthritis.


Eligibility

Inclusion Criteria2

  • Diagnosis of Osteoarthritis
  • 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

Athens Beverly Hills Medical Group

Glyfada, Athens, Greece

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NCT05147675


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