RecruitingPhase 1NCT05018793

Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for SCI

Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury


Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Enrollment

15 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cells for the treatment of spinal cord injury


Eligibility

Inclusion Criteria2

  • Diagnosis of Spinal Cord Injury
  • Understanding and willingness to sign a written informed consent document

Exclusion Criteria11

  • Active infection
  • Active cancer
  • Chronic multisystem organ failure
  • Pregnancy
  • Anticoagulation medicine use
  • Clinically significant Abnormalities on pre-treatment laboratory evaluation
  • Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
  • Previous organ transplant
  • Hypersensitivity to sulfur
  • Continued drug abuse
  • Pre-menopausal women not using contraception

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Interventions

BIOLOGICALautologous adipose derived mesenchymal stem cells

cultured autologous adult adipose derived mesenchymal stem cells

BIOLOGICALAlloRx

Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal injection for


Locations(2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Athens Beverly Hills Medical Group

Glyfada, Athens, Greece

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NCT05018793


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