NCT06129175

UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX)

Cytopeutics® A Phase II-III Double-Blind Randomized Controlled Study to Assess the Efficacy of Umbilical Cord Mesenchymal Stem Cells (Neuroncell-EX) Transplantation in Patients With Acute Ischemic Stroke

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cytopeutics Sdn. Bhd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the functional recovery based on Barthel index (BI) and modified Rankin Scale (mRS) while the secondary objectives are to assess the survival and re-admission rate as well as to investigate the inflammatory response in a subclinical study within 1 year of Neuroncell-EX infusion in participants with acute ischemic stroke.

Detailed description

Background: Ischemic stroke is a serious cerebrovascular disease with high morbidity and disability worldwide. Despite the great efforts that have been made, the prognosis of stroke patients remains unsatisfactory. Mesenchymal stem cells (MSCs) therapy is an emerging treatment studied in various medical conditions including autoimmune, inflammatory as well as central nervous system diseases. The mechanism of MSCs in the treatment of ischemic stroke involved with immune regulation, neuroprotection, angiogenesis, and neural circuit reconstruction. A large number of preclinical data have proved the feasibility of MSCs in the treatment of stroke where the administration of MSCs can alleviate neurological deficits. Similarly, a number of clinical trials have also proved the effectiveness and safety of MSCs in the treatment of stroke. Among these is a phase 2, single-center, assessor-blinded randomized controlled study by investigators using bone marrow-derived MSCs in patients with subacute middle cerebral artery infarct. The investigators demonstrated the safety, tolerability, and efficacy of intravenous infusion of MSCs with significant improvement in median infarct volume (Law et al., 2021). Objective: To determine the efficacy of intravenous infusion of allogeneic Cytopeutics umbilical cord mesenchymal stem cells (Neuroncell-EX) in participants with acute ischemic stroke. Study Design: This is a phase II-III double-blind randomized controlled study involving 80 participants, diagnosed with acute ischemic stroke admitted to HCTM-UKM. Investigational treatment arm (Group A-MSCs) consist of 40 participants will receive Neuroncell-EX whereas control treatment arm (Group B-Control) consist of 40 participants will receive placebo. Both groups will also receive standard medical care for acute stroke. Efficacy assessments will include Barthel index (BI) and modified Rankin Scale (mRS), Functional Magnetic Resonance Imaging (fMRI) and blood tests including biomarkers within 12 months follow-up.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
BIOLOGICAL	Neuroncell-EX	Intravenous infusion of Neuroncell-EX (2 million UCMSCs per kg body weight) on day 1 and day 14 plus standard medical care.
OTHER	Placebo	Intravenous infusion of Placebo (normal saline) on day 1 and day 14 plus standard medical care.

Timeline

• Start date: 2023-12-19
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2023-11-13
• Last updated: 2026-01-02

Locations

1 site across 1 country: Malaysia