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

Last updated: April 2, 2025
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

AlloRx

Clinical Study ID

NCT05018767
SC-11-ATG-12-01
  • 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 Aging Frailty

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Aging Frailty

  • Understanding and willingness to sign a written informed consent document

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.

  • Continued drug abuse

  • Pre-menopausal women not using contraception

  • Previous organ transplant

  • Hypersensitivity to sulfur

Study Design

Total Participants: 86
Treatment Group(s): 1
Primary Treatment: AlloRx
Phase: 1
Study Start date:
January 22, 2022
Estimated Completion Date:
December 01, 2027

Study Description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Aging Frailty. 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 Frailty. Patients with Frailty 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

  • Athens Beverly Hills Medical Group

    Glyfáda, Athens 16675
    Greece

    Active - Recruiting

  • Artros

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

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