Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R Inj.) Treatment in Patients With ALS

  • End date
    May 3, 2026
  • participants needed
  • sponsor
    Corestem, Inc.
Updated on 22 October 2021


ALSUMMIT is a double-blind, randomized, placebo-controlled, multi-center, parallel, phase III clinical trial to evaluate and confirm the efficacy and long-term safety of repeated Lenzumestrocel (Neuronata-R inj.) treatment.


Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder characterized by selective and progressive loss of motor neurons. Disease progression leads to death within 2-4 years, but there exists no definite treatment so far.

Based on phase I/II clinical trial(NCT01363401), twice intrathecal autologous bone marrow-derived mesenchymal stem cells (Lenzumestrocel) injections showed significant therapeutic benefit lasting at least six months with safety in patients with ALS.

Additionally, the switch from pro- to anti-inflammatory conditions, which was indicated from the inverse correlation between TGF-1 and MCP-1 levels after Lenzumestrocel injections in the good responder, has been considered a plausible beneficial action mechanism.

This study is designed to investigate the following. First, to reconfirm and evaluate the long-term efficacy of twice injections (single cycle) of Lenzumestrocel, group 1 will receive a single cycle injection with a 26-day interval.

Second, to evaluate the long-term safety and efficacy of Lenzumestrocel repeated injections, group 2 will receive a single cycle injection a 26-day apart followed by three times injections every three-month interval.

Group 3 will receive comparator injections.

Condition Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, Myelopathy, lou gehrig's disease, Amyotrophic Lateral Sclerosis
Treatment Placebo Comparator, Riluzole, Lenzumestrocel
Clinical Study IdentifierNCT04745299
SponsorCorestem, Inc.
Last Modified on22 October 2021


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