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

NCT06129175 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-02

No results posted yet for this study

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.

Conditions

  • Acute Ischemic Stroke

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.

Sponsors & Collaborators

  • National University of Malaysia

    collaborator OTHER

  • Cytopeutics Sdn. Bhd.

    lead INDUSTRY

Principal Investigators

  • Wan Nur Nafisah Wan Yahya · National University of Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06129175 on ClinicalTrials.gov