Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)

Prior treatment

• Prior stem cell therapy of any kind.

Other illness

• Any unstable clinically significant medical condition other than ALS
• Any history of malignancy, within the previous 5 years, with the exception of localized skin cancers, cervical cancer in-situ or prostate cancer in-situ (with no evidence of metastasis, significant invasion, or reoccurrence within 3 years of baseline).
• Primary brain cancer or cancer with CNS involvement is exclusionary.
• Other types of motor neuron disease such as primary lateral sclerosis, progressive muscular atrophy, and progressive bulbar palsy.

Other

• Active participation in any other ALS interventional study.
• Inability to lie flat for the duration of IT cell treatment and/or bone marrow biopsy, or inability to tolerate study procedures for any other reason.
• Usage of a feeding tube at Screening Visit 1 or Screening Visit 2.
• Pregnant women or women currently breastfeeding.

• Male and female participants 18 to 75 years old (inclusive) at Screening Visit 1.
• ALS diagnosed as laboratory-supported probable, clinically probable, or definite as defined by the revised El Escorial criteria.
• Having onset of ALS symptoms, including muscle weakness, within 24 months from Screening Visit 1.
• ≥2 points on each item of the ALSFRS-R at the Screening Visit 1.
• ≤45 points on ALSFRS-R total score at Screening Visit 1.
• Upright slow vital capacity (SVC) measure ≥65% of predicted for gender, height, and age at Screening Visit 1.
• Participants must adhere to highly effective methods of contraception as specified in the study protocol.