Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for SCI
Study Details
Study Description
Brief Summary
This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Spinal Cord Injury.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Spinal Cord Injury (SCI). This patient funded trial aims to study the safety and efficacy of intravenous and intrathecal delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of SCI. 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment Group (AlloRx) intravenous infusion and intrathecal injection (total of 100 million cells) |
Biological: AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
|
Outcome Measures
Primary Outcome Measures
- Safety (adverse events) [Four year follow-up]
Clinical monitoring of possible adverse events or complications
Secondary Outcome Measures
- Efficacy: American Spinal Injury Association Impairment Scale (ASIA) [Four year follow-up]
It will be completed for each follow up point
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of Spinal Cord 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
-
Anticoagulation medicine use
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medical Surgical Associates Center | St. John's | Antigua and Barbuda |
Sponsors and Collaborators
- The Foundation for Orthopaedics and Regenerative Medicine
Investigators
- Principal Investigator: Chadwick Prodromos, MD, The Foundation for Orthopaedics and Regenerative Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Bydon M, Dietz AB, Goncalves S, Moinuddin FM, Alvi MA, Goyal A, Yolcu Y, Hunt CL, Garlanger KL, Del Fabro AS, Reeves RK, Terzic A, Windebank AJ, Qu W. CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury. Mayo Clin Proc. 2020 Feb;95(2):406-414. doi: 10.1016/j.mayocp.2019.10.008. Epub 2019 Nov 27.
- Hur JW, Cho TH, Park DH, Lee JB, Park JY, Chung YG. Intrathecal transplantation of autologous adipose-derived mesenchymal stem cells for treating spinal cord injury: A human trial. J Spinal Cord Med. 2016 Nov;39(6):655-664. Epub 2015 Jul 24.
- Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4.
- ATG-1-MSC-012