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

NCT05018832 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: SC-20-ATG-12-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 traumatic brain injury

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; stem cell treatment

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events)

  Clinical monitoring of possible adverse events or complications

  Four year follow-up

Study Arms (1)

Treatment Group (AlloRx)

EXPERIMENTAL

Single intravenous infusion of 100 million cells

Biological: AlloRx

Interventions

AlloRx BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group (AlloRx)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Foundation for Orthopaedics and Regenerative Medicine: lead

Study Sites (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Location

Related Publications (3)

• Wang S, Cheng H, Dai G, Wang X, Hua R, Liu X, Wang P, Chen G, Yue W, An Y. Umbilical cord mesenchymal stem cell transplantation significantly improves neurological function in patients with sequelae of traumatic brain injury. Brain Res. 2013 Sep 26;1532:76-84. doi: 10.1016/j.brainres.2013.08.001. Epub 2013 Aug 11.

  PMID: 23942181 BACKGROUND

• Tian C, Wang X, Wang X, Wang L, Wang X, Wu S, Wan Z. Autologous bone marrow mesenchymal stem cell therapy in the subacute stage of traumatic brain injury by lumbar puncture. Exp Clin Transplant. 2013 Apr;11(2):176-81. doi: 10.6002/ect.2012.0053. Epub 2012 Aug 11.

  PMID: 22891928 BACKGROUND

• Wang Z, Luo Y, Chen L, Liang W. Safety of neural stem cell transplantation in patients with severe traumatic brain injury. Exp Ther Med. 2017 Jun;13(6):3613-3618. doi: 10.3892/etm.2017.4423. Epub 2017 May 4.

  PMID: 28588689 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Chadwick Prodromos, MD

  The Foundation for Orthopaedics and Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 24, 2021
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)