Brainstorm Clinical Trial for ALS

Condition: Amyotrophic lateral sclerosis (ALS)

Eligibility

Key Inclusion Criteria

  • 18-60 years old
  • ALS diagnosed as possible, laboratory-supported probable, probable or definite
  • Having onset of ALS disease symptoms within 24 months at the screening visit

Key Exclusion Criteria

  • Prior stem cell therapy of any kind
  • Active participation in any other ALS interventional study
  • Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate study procedures

Full Study Name

A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate Efficacy and Safety of Repeated Administrations of NurOwn (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Subjects With Amyotrophic Lateral Sclerosis (ALS) (IRB no. 49800)

Summary

This study focuses on patients who have been diagnosed with amyotrophic lateral sclerosis (ALS) with symptoms less than two years. The study is designed to test the investigational use of NurOwn (MSC-NTF cells), a type of cell derived from an individual’s own bone marrow. Researchers aim to determine whether repeated dosing of NurOwn is safe without causing too many side effects and whether it may decrease the rate of ALS decline.

MSC-NTF are specialized cells which are made to release chemicals to support the nervous system. Cell treatment in this study only involves cells from the participant’s body. Researchers will compare NurOwn to placebo (inactive substance); participants will be randomly assigned to receive either NurOwn or placebo.

Phase

Phase III


Principal Investigator

Robert Baloh, MD, PhD

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