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

The Foundation for Orthopaedics and Regenerative Medicine20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

AlloRxBIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Outcomes

Primary Outcomes

Safety (adverse events)

Clinical monitoring of possible adverse events or complications

Time frame: Four year follow-up

Secondary Outcomes

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.

Time frame: Four year follow-up

Data from ClinicalTrials.gov

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