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Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS

NCT02017912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-06-06

Study results available
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Summary

This is a multi-center, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in patients with ALS .

MSC-NTF cells are a novel cell-therapeutic approach which is expected to effectively deliver Neurotrophic factors, which are potent survival factors for neurons, directly to the site of damage.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

BIOLOGICAL

Nurown MSC-NTF cells

Single autologous MSC-NTF cells treatment by combined intramuscular and intrathecal administration

BIOLOGICAL

Placebo

Excipient administration by combined intramuscular and intrathecal administration

Sponsors & Collaborators

  • Brainstorm-Cell Therapeutics

    lead INDUSTRY

Principal Investigators

  • Merit Cudkowicz, MD · Massachusetts General Hospital

  • Robert H Brown, D.Phil, M.D. · UMass Medical School

  • Anthony J. Windebank, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-03-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02017912 on ClinicalTrials.gov