Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for MS
Study Details
Study Description
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 multiple sclerosis
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 1 |
Detailed Description
Multiple Sclerosis (MS) can be a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and efficacious for the treatment of MS. Patients with MS will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for the infusion 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 Single intravenous infusion 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: Kurtzke Expanded Disability Status Scale (EDSS) [Four year follow-up]
EDSS is a scale to evaluate the function of the central nervous system. It will be completed for each follow up point
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Multiple Sclerosis
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Understanding and willingness to sign a written informed consent document
Exclusion Criteria:
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Active infection
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Active cancer
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Chronic multisystem organ failure
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Pregnancy
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Clinically significant abnormalities on pre-treatment laboratory evaluation
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Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
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Continued drug abuse
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Pre-menopausal women not using contraception
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Previous organ transplant
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Hypersensitivity to sulfur
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
- Li JF, Zhang DJ, Geng T, Chen L, Huang H, Yin HL, Zhang YZ, Lou JY, Cao B, Wang YL. The potential of human umbilical cord-derived mesenchymal stem cells as a novel cellular therapy for multiple sclerosis. Cell Transplant. 2014;23 Suppl 1:S113-22. doi: 10.3727/096368914X685005. Epub 2014 Nov 5.
- Meyer-Moock S, Feng YS, Maeurer M, Dippel FW, Kohlmann T. Systematic literature review and validity evaluation of the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis. BMC Neurol. 2014 Mar 25;14:58. doi: 10.1186/1471-2377-14-58. Review.
- Petrou P, Kassis I, Levin N, Paul F, Backner Y, Benoliel T, Oertel FC, Scheel M, Hallimi M, Yaghmour N, Hur TB, Ginzberg A, Levy Y, Abramsky O, Karussis D. Beneficial effects of autologous mesenchymal stem cell transplantation in active progressive multiple sclerosis. Brain. 2020 Dec 1;143(12):3574-3588. doi: 10.1093/brain/awaa333.
- Riordan NH, Morales I, Fernández G, Allen N, Fearnot NE, Leckrone ME, Markovich DJ, Mansfield D, Avila D, Patel AN, Kesari S, Paz Rodriguez J. Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis. J Transl Med. 2018 Mar 9;16(1):57. doi: 10.1186/s12967-018-1433-7. Erratum in: J Transl Med. 2021 May 10;19(1):197.
- SC-8-ATG-9-03