RecruitingPhase 2Phase 3NCT06129175

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


Sponsor

Cytopeutics Sdn. Bhd.

Enrollment

80 participants

Start Date

Dec 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Neuroncell-EX and Placebo for people with acute ischemic stroke. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNeuroncell-EX

Intravenous infusion of Neuroncell-EX (2 million UCMSCs per kg body weight) on day 1 and day 14 plus standard medical care.

OTHERPlacebo

Intravenous infusion of Placebo (normal saline) on day 1 and day 14 plus standard medical care.


Locations(1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, Malaysia

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NCT06129175


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