Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for TBI
NCT ID: NCT05018832
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-12-31
2028-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CKD
NCT05018845
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer
NCT05158127
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for Stroke
NCT05158101
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Diabetes
NCT05003908
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty
NCT05018767
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Group (AlloRx)
Single intravenous infusion of 100 million cells
AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Understanding and willingness to sign a written informed consent document
Exclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Foundation for Orthopaedics and Regenerative Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chadwick Prodromos, MD
Role: PRINCIPAL_INVESTIGATOR
The Foundation for Orthopaedics and Regenerative Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Surgical Associates Center
St John's, , Antigua and Barbuda
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SC-20-ATG-12-4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.