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UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX)
Sponsor: Cytopeutics Sdn. Bhd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-12-19
Completion Date
2026-12-31
Last Updated
2026-01-02
Healthy Volunteers
No
Conditions
Interventions
Neuroncell-EX
Intravenous infusion of Neuroncell-EX (2 million UCMSCs per kg body weight) on day 1 and day 14 plus standard medical care.
Placebo
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