bone marrow-derived mesenchymal stem cells / CoreStem - LARVOL DELTA

Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Corestemchemon, Inc.

New P1 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

ALSummit: Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS (clinicaltrials.gov) - P3 | N=115 | Active, not recruiting | Sponsor: Corestemchemon, Inc. | Trial primary completion date: Oct 2023 ➔ Dec 2024

Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • CCL4 • IL10 • IL6 • TGFB1 • TNFA

A Propensity-Score-Matched Control Surveillance Study of Intrathecal Autologous Bone Marrow-Derived Mesenchymal Stem Cells (Neuronata-R®) Treatment in Patients with ALS to Assess the Long-Term Survival Benefits (ALS-MND 2023) - "The findings highlight lenzumestrocel as a promising autologous BM-MSC therapy for ALS. mhkim@csco.co.kr"

Clinical • Amyotrophic Lateral Sclerosis • CNS Disorders

ALSummit: Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS (clinicaltrials.gov) - P3 | N=115 | Active, not recruiting | Sponsor: Corestem, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Amyotrophic Lateral Sclerosis • CNS Disorders

Long-term survival benefits of intrathecal autologous bone marrow-derived mesenchymal stem cells (Neuronata-R®: lenzumestrocel) treatment in ALS: Propensity-score-matched control, surveillance study. (PubMed, Front Aging Neurosci) - "Additionally, there were no serious adverse drug reactions found during the safety assessment, lasting a year after the first administration. The results of the present study showed that lenzumestrocel treatment had a long-term survival benefit in real-world ALS patients."

Journal • Amyotrophic Lateral Sclerosis • CNS Disorders

Safety and tolerability of bone marrow-derived mesenchymal stem cells in lupus animal models and a phase I clinical trial in humans. (PubMed, Lupus) - P1 | "We defined the characteristics of BM-MSCs and identified their safety and tolerability in both animal models and a phase I clinical trial. The maximum tolerated dose was determined to be 3.0×10 cells/kg in patients with LN."

Journal • P1 data • Preclinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Musculoskeletal Pain • Nephrology • Oncology • Systemic Lupus Erythematosus • Transplantation

Efficacy and safety of Lenzumestrocel (Neuronata-R® inj.) in patients with amyotrophic lateral sclerosis (ALSUMMIT study): study protocol for a multicentre, randomized, double-blind, parallel-group, sham procedure-controlled, phase III trial. (PubMed, Trials) - P3 | "Lenzumestrocel is the orphan cell therapy product for ALS conditionally approved by the South Korea Ministry of Food and Drug Safety (MFDS). This ALSUMMIT protocol was developed for the adoption of enrichment enrolment, add-on design, and consideration of ethical issues for the placebo group."

Clinical • Clinical protocol • Journal • P3 data • Amyotrophic Lateral Sclerosis • CNS Disorders