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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Biological: AlloRx


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>three intrathecal injections of 50 million cells at two-month intervals. | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyotrophic Lateral Sclerosis, ALS, Stem cells