- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05018832
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for TBI
July 20, 2022 updated by: The Foundation for Orthopaedics and Regenerative Medicine
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Traumatic Brain Injury
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
St. John's, Antigua and Barbuda
- Medical Surgical Associates Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group (AlloRx)
Single intravenous infusion of 100 million cells
|
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (adverse events)
Time Frame: Four year follow-up
|
Clinical monitoring of possible adverse events or complications
|
Four year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2022
Primary Completion (Anticipated)
November 1, 2025
Study Completion (Anticipated)
November 1, 2025
Study Registration Dates
First Submitted
August 20, 2021
First Submitted That Met QC Criteria
August 20, 2021
First Posted (Actual)
August 24, 2021
Study Record Updates
Last Update Posted (Actual)
July 22, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC-20-ATG-12-4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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