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

The Foundation for Orthopaedics and Regenerative Medicine

Status and phase

Begins enrollment in 4 months

Phase 1

Conditions

Traumatic Brain Injury

Treatments

Biological: AlloRx

Study type

Interventional

Funder types

Other

Identifiers

NCT05018832

SC-20-ATG-12-4

Details and patient eligibility

About

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 traumatic brain injury

Full description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Traumatic brain injury (TBI). 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 TBI. Patients with TBI 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.

Enrollment

20 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of traumatic brain injury
Understanding and willingness to sign a written informed consent document

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) compromise patient's safety.
Continued drug abuse
Pre-menopausal women not using contraception
Previous organ transplant
Hypersensitivity to sulfur
Seizure disorders