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

Last updated: April 15, 2025
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Overall Status: Active - Recruiting

Phase

1

Condition

Spinal Cord Injuries

Treatment

AlloRx

autologous adipose derived mesenchymal stem cells

Clinical Study ID

NCT05018793
SC-8-GR-10-02
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Spinal Cord Injury

  • Understanding and willingness to sign a written informed consent document

Exclusion

Exclusion Criteria:

  • 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) compromisepatient's safety.

  • Previous organ transplant

  • Hypersensitivity to sulfur

  • Continued drug abuse

  • Pre-menopausal women not using contraception

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: AlloRx
Phase: 1
Study Start date:
December 01, 2024
Estimated Completion Date:
December 31, 2028

Study Description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (SCI). This patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cell for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-MSCs. 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.

Connect with a study center

  • Medical Surgical Associates Center

    St. John's,
    Antigua and Barbuda

    Active - Recruiting

  • Athens Beverly Hills Medical Group

    Glyfáda, Athens 16675
    Greece

    Active - Recruiting

  • Mitera Hospital Athens Greece

    Marousi,
    Greece

    Site Not Available

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