A randomized placebo-controlled phase 3 study of mesenchymal stem cells induced to secrete high levels of neurotrophic factors in amyotrophic lateral sclerosis.

Using the observed baseline study mean (ALSFRS‐R ≥ 31), the difference in the percentage of MSC‐NTF versus placebo responders increased, and the increase in sample size produced a nominally significant P ‐value ( P < .05, Table 4 ).

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Discussion The study did not reach statistical significance on the primary endpoint.

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While the primary and secondary endpoints failed to reach statistical significance in the overall study population, a pre‐specified subgroup suggests across endpoints that MSC‐NTF participants with less severe disease may have retained more function compared to placebo.

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