NCS-01 / NC Medical Research - LARVOL DELTA

A Study of NCS-01 in Patients With Acute Ischemic Stroke (clinicaltrials.gov) - P1/2 | N=16 | Active, not recruiting | Sponsor: NC Medial Research Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Ischemic stroke

A Study of NCS-01 in Patients With Acute Ischemic Stroke (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: NC Medial Research Inc | Trial completion date: Oct 2024 ➔ Oct 2028 | Trial primary completion date: Oct 2023 ➔ Oct 2027

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

A First-in-human Phase 1/2, Dose-finding, Double-blind, Placebo-controlled, Multi-center Study To Evaluate The Safety, Tolerability Of Intra-artery Administration Of Bone Marrow Derived Mesenchymal Stem Cells (ncs-01) In Patients With Acute Ischemic Stroke (ISC 2023) - "Trial Status: This study has enrolled only one subject, but is planned for a total of US 6 sites in the US. Study contact: Sean I. Savitz MD (Sean.I.Savitz@uth.tmc.edu)."

Clinical • P1/2 data • Cardiovascular • Ischemic stroke

A Study of NCS-01 in Patients With Acute Ischemic Stroke (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: NC Medial Research Inc | Trial completion date: Oct 2021 ➔ Oct 2024 | Trial primary completion date: Oct 2021 ➔ Oct 2023

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Bone marrow-derived NCS-01 cells for ischemic stroke. (PubMed, Brain Circ) - "NCS-01 cells, in comparison with other lines of stem cells (Li cells), are shown to produce greater therapeutic effects, most likely due to the observed filopodia formation that allows the stem cells to extend and target the ischemic cells. Given these findings, NCS-01 stem cells serve as a potential treatment for stroke through the demonstration of profound efficacy and further research that favors their filopodia-mediated mechanism of action."

Journal • Review • Cardiovascular • Ischemic stroke

Bone Marrow-Derived NCS-01 Cells Advance a Novel Cell-Based Therapy for Stroke. (PubMed, Int J Mol Sci) - "In this review, we discuss recent preclinical advancements using in vitro and in vivo ischemia models that support the transplantation of NCS-01 in human stroke trials. These results, coupled with the recommendations put forth by the consortium of Stem cell Therapeutics as an Emerging Paradigm for Stroke (STEPS), highlight a framework for conducting preclinical research with the ultimate goal of initiating clinical trials."

Journal • Review • Cardiovascular • Gene Therapies • Genetic Disorders • Ischemic stroke • Reperfusion Injury • Transplantation • FGF • IL6

A Study of NCS-01 in Patients With Acute Ischemic Stroke (clinicaltrials.gov) - P1/2; N=16; Recruiting; Sponsor: NC Medial Research Inc; Not yet recruiting ➔ Recruiting; Initiation date: Aug 2019 ➔ Feb 2020

Clinical • Enrollment open • Trial initiation date • MRI

Translating intracarotid artery transplantation of bone marrow-derived NCS-01 cells for ischemic stroke: Behavioral and histological readouts and mechanistic insights into stem cell therapy. (PubMed, Stem Cells Transl Med) - "NCS-01 cells secreted therapeutic molecules, such as basic fibroblast growth factor and interleukin-6, but equally importantly we observed for the first time the formation of filopodia by NCS-01 cells under stroke conditions, characterized by cadherin-positive processes extending from the stem cells toward the ischemic cells. Collectively, the present efficacy readouts and the novel filopodia-mediated mechanism of action provide solid lab-to-clinic evidence supporting the use of NCS-01 cells for treatment of stroke in the clinical setting."

Journal • IL6