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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Corestemchemon, Inc.

Conditions:

Amyotrophic Lateral Sclerosis

Eligibility:

All Genders

25-75 years

Phase:

PHASE3

Brief Summary

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 (Neuro...

Detailed Description

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 exi...

Eligibility Criteria

Inclusion

  • \[Inclusion Criteria\]
  • Subjects who show both upper motor neuron signs and lower motor neuron signs at the same time in neurological tests.
  • Among subjects diagnosed with familial or sporadic ALS, subjects falling into clinically definite ALS, probable ALS and probable ALS-lab supported according to The revised World Federation of Neurology El Escorial Criteria\[Rix Brooks, 2000\], during 17-weeks period prior to the administration and ALSFRS-R score (progression rate) of 1.03 ± 50%/month (meaning mean value in that total period).
  • For subjects who are under Riluzole treatment, those who have received stable dose of Riluzole for more than 28 days before screening visit.
  • Subjects with duration of disease of no more than 2 years from the first diagnosis date.
  • Subjects whose ALSFRS-R scores are in the range of 31\~46 at the time of screening (P-V0).
  • \[Exclusion Criteria\]
  • Subjects who received tracheostomy or use ventilators (including positive pressure ventilators; subjects who use non-invasive ventilation for sleep apnea may be allowed after review) at the time of screening (P-V0).
  • Subjects who received gastrotomy at the time of screening (P-V0).
  • Subjects for whom clinical efficacy evaluation is not possible because pulmonary functional tests cannot be conducted at the time of screening (P-V0) or subjects whose forced vital capacity is found to be not greater than 40%of the expected value.
  • Subjects who fall into above Class II according to the New York Heart Association's functional classification, who have showed myocardial infarction, unstable arrhythmia and/or other significant cardiovascular diseases such as unstable angina in the past 3 months, or who show electrocardiographic signs of myocardial infarction or angina at the time of screening (P-V0) or who received stent insertion or coronary artery bypass grafting.
  • Subjects who have received other investigational products or edaravone within 3 month or 5 half-lives at the time of screening (P-V0) and lead in period visit L-V1 (evaluated by whichever is longer).
  • Subjects who have experienced epileptic seizure.
  • Subjects with severe renal disorder (serum creatinine: not less than 2.0 mg/dL).
  • Subjects with severe hepatic disorder (ALT, AST, or bilirubin: over 2.0 times of the normal upper limit).
  • Subjects who show hemorrhagic tendency at the time of screening (PT and aPTT \> 1.5 x ULN)
  • Subjects who are found to have active viral infections (HBsAg, HCV Ab, HIV Ab, CMV IgM, EBV IgM, HSV IgM and Treponema pallidum) at the time of screening.
  • Subjects with hypersensitivity to antibiotics (penicillin or streptomycin).
  • Subjects who have ever received any cell therapy product for the same disease.
  • Subjects with any malignant tumor in the past 5 years before screening, except malignant tumors with very low risk of metastasis or death.

Exclusion

    Key Trial Info

    Start Date :

    March 23 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    May 3 2026

    Estimated Enrollment :

    115 Patients enrolled

    Trial Details

    Trial ID

    NCT04745299

    Start Date

    March 23 2021

    End Date

    May 3 2026

    Last Update

    January 10 2025

    Active Locations (5)

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    Page 1 of 2 (5 locations)

    1

    Pusan National University Yangsan Hospital

    Yangsan, Kyungsangnam-do, South Korea, 50612

    2

    Hanyang university hospital

    Seoul, Seoul, South Korea, 04763

    3

    Korea University Anam Hospital

    Seoul, South Korea, 02841

    4

    Samsung Medical Center

    Seoul, South Korea, 06351