Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS
Study Details
Study Description
Brief Summary
This trial will study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of amyotrophic lateral sclerosis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Amyotrophic lateral sclerosis is a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and can improve the prognosis of afflicted patients. Patients with ALS will receive three intrathecal injections of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for each injection will be 50 million cells and the injections will be at two-month intervals. 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 three intrathecal injections of 50 million cells at two-month intervals. |
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: revised ALS functional rating scale (ALSFRS-R) [Four year follow-up]
ALSFRS-R scale is used to evaluate the progression of disability in patients with ALS. It will be completed for each follow up point.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of Amyotrophic Lateral 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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Anticoagulation medicine use
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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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Previous organ transplant
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Hypersensitivity to sulfur
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Continued drug abuse
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Pre-menopausal women not using contraception
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
- Barczewska M, Maksymowicz S, Zdolińska-Malinowska I, Siwek T, Grudniak M. Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis: an Original Study. Stem Cell Rev Rep. 2020 Oct;16(5):922-932. doi: 10.1007/s12015-020-10016-7.
- Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21.
- Oh KW, Noh MY, Kwon MS, Kim HY, Oh SI, Park J, Kim HJ, Ki CS, Kim SH. Repeated Intrathecal Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis. Ann Neurol. 2018 Sep;84(3):361-373. doi: 10.1002/ana.25302. Epub 2018 Aug 31.
- Petrou P, Gothelf Y, Argov Z, Gotkine M, Levy YS, Kassis I, Vaknin-Dembinsky A, Ben-Hur T, Offen D, Abramsky O, Melamed E, Karussis D. Safety and Clinical Effects of Mesenchymal Stem Cells Secreting Neurotrophic Factor Transplantation in Patients With Amyotrophic Lateral Sclerosis: Results of Phase 1/2 and 2a Clinical Trials. JAMA Neurol. 2016 Mar;73(3):337-44. doi: 10.1001/jamaneurol.2015.4321.
- SC-7-ATG-7-01