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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Suspended
Phase
Phase 1
Locations
Antigua and Barbuda
Study Type
Interventional
Intervention
AlloRx
Sponsored by
The Foundation for Orthopaedics and Regenerative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, ALS, Stem cells

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Surgical Associates Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

three intrathecal injections of 50 million cells at two-month intervals.

Outcomes

Primary Outcome Measures

Safety (adverse events)
Clinical monitoring of possible adverse events or complications

Secondary Outcome Measures

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.

Full Information

First Posted
August 6, 2021
Last Updated
October 6, 2022
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05003921
Brief Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS
Official Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
Modifying Protocol
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Foundation for Orthopaedics and Regenerative Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, ALS, Stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
three intrathecal injections of 50 million cells at two-month intervals.
Intervention Type
Biological
Intervention Name(s)
AlloRx
Intervention Description
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Safety (adverse events)
Description
Clinical monitoring of possible adverse events or complications
Time Frame
Four year follow-up
Secondary Outcome Measure Information:
Title
Efficacy: revised ALS functional rating scale (ALSFRS-R)
Description
ALSFRS-R scale is used to evaluate the progression of disability in patients with ALS. It will be completed for each follow up point.
Time Frame
Four year follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chadwick Prodromos, MD
Organizational Affiliation
The Foundation for Orthopaedics and Regenerative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Surgical Associates Center
City
St. John's
Country
Antigua and Barbuda

12. IPD Sharing Statement

Citations:
PubMed Identifier
10540002
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. doi: 10.1016/s0022-510x(99)00210-5.
Results Reference
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PubMed Identifier
26751635
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.
Results Reference
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PubMed Identifier
32725316
Citation
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.
Results Reference
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PubMed Identifier
30048006
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.
Results Reference
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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS

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