Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05003921
• Other study ID #: SC-7-ATG-7-01
• Status: Suspended
• Phase: Phase 1
• Start date: December 2022
• Est. completion date: September 2025

Study information

• Verified date: October 2022
• Source: The Foundation for Orthopaedics and Regenerative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of Amyotrophic Lateral Sclerosis.

• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection

• Active cancer

• Chronic multisystem organ failure

• Pregnancy

• Anticoagulation medicine use

• Clinically significant Abnormalities on pre-treatment laboratory evaluation

• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.

• Previous organ transplant

• Hypersensitivity to sulfur

• Continued drug abuse

• Pre-menopausal women not using contraception

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Biological:
• AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations

Country	Name	City	State
Antigua and Barbuda	Medical Surgical Associates Center	St. John's

Sponsors (1)

Lead Sponsor	Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Country where clinical trial is conducted

Antigua and Barbuda, 

References & Publications (4)

Barczewska M, Maksymowicz S, Zdolinska-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events)	Clinical monitoring of possible adverse events or complications	Four year follow-up
Secondary	Efficacy: revised ALS functional rating scale (ALSFRS-R)	ALSFRS-R scale is used to evaluate the progression of disability in patients with ALS. It will be completed for each follow up point.	Four year follow-up