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

Last updated: April 4, 2025
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Overall Status: Active - Recruiting

Phase

1

Condition

Cerebral Palsy

Treatment

AlloRx

Clinical Study ID

NCT05018819
SC-11-ATG-11-02
  • All Genders

Study 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 Cerebral Palsy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Cerebral Palsy

Exclusion

Exclusion Criteria:

  • 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) compromisepatient's safety

  • Previous organ transplant

  • Seizure disorder

  • Hypersensitivity to sulfur

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: AlloRx
Phase: 1
Study Start date:
February 01, 2022
Estimated Completion Date:
November 30, 2027

Study Description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Cerebral Palsy (CP). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of UC-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

  • Center for Investigation in Tissue Engineering and Cellular Therapy

    Buenos Aires,
    Argentina

    Site Not Available

  • Athens Beverly Hills Medical Group

    Glyfáda, Athens 16675
    Greece

    Active - Recruiting

  • Medyca Bosques

    San Pedro Garza García, N.L
    Mexico

    Site Not Available

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