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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

March 23, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

May 3, 2026

Conditions
Amyotrophic Lateral Sclerosis
Interventions
BIOLOGICAL

Lenzumestrocel

Single cycle administration group : injections twice in a 26-day interval Multiple administration group : injections twice in a 26-day interval followed by repeated three times injections every three months

DRUG

Riluzole

concomitant administration of Riluzole to all groups, except subjects to whom Riluzole administration is deemed impossible owing to adverse events as determined by medical experts

DRUG

Placebo Comparator

"Single cycle administration group: Placebo comparator is injected three times every three months after injection of Lenzumestrocel twice in a 26-day interval.~Control group: Placebo comparator is injected twice in a 26-day interval followed by repeated three times injcections every three months"

Trial Locations (5)

50612

Pusan National University Yangsan Hospital, Yangsan

04763

Hanyang university hospital, Seoul

02841

Korea University Anam Hospital, Seoul

06351

Samsung Medical Center, Seoul

Unknown

Seoul National University Hospital, Seoul

Sponsors
All Listed Sponsors
lead

Corestemchemon, Inc.

INDUSTRY

NCT04745299 - Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients with ALS | Biotech Hunter | Biotech Hunter