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RECRUITING
NCT06129175
PHASE2/PHASE3

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

Sponsor: Cytopeutics Sdn. Bhd.

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, Malaysia