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

NCT06129175 | Recruiting Phase 2 DMC

• 1 other identifier: POD0031/CP/R
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

• Barthel Index (BI)

  Functional recovery after stroke onset is measured by the Barthel Index (BI). BI score from 0-100, higher scores mean better outcome. The investigators measure and compare the BI score for ischemic stroke patients who received Neuroncell-EX and control treatments.

  Baseline, 6 weeks, 3 months, 6 months and 12 months

• Modified Rankin Scale

  Functional recovery after stroke onset is measured by the modified Rankin Scale (mRS). mRS is a 7 point (0-6) ranking scale to assess neurological disability. A score of 0 indicates normal functions with no symptoms while higher scores indicates more severe neurological disability.The investigators measure and compare the mRS score for ischemic stroke patients who received Neuroncell-EX and control treatments.

  Baseline, 6 weeks, 3 months, 6 months and 12 months

Secondary Outcomes (3)

• Number of participants with adverse events due to umbilical cord-derived mesenchymal stem cells infusion as assessed by clinical examination.

  Baseline, day 1, day 14, 6 weeks, 3 months, 6 months and 12 months

• Survival and Re-admission rate

  Baseline, day 1, day 14, 6 weeks, 3 months, 6 months and 12 months

• Blood inflammatory markers before and after umbilical cord derived mesenchymal stem cell infusion based on subclinical analysis.

  Baseline, 6 months and 12 months

Study Arms (2)

Neuroncell-EX

EXPERIMENTAL

Umbilical cord-derived mesenchymal stem cells

Biological: Neuroncell-EX

Control

PLACEBO COMPARATOR

Normal saline

Other: Placebo

Interventions

Neuroncell-EX BIOLOGICAL

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

Neuroncell-EX

Placebo OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be aged ≥ 18 years old.
• Patients with acute ischemic stroke symptom onset within 4 weeks.
• Patients diagnosed with "moderate to severe" based on NIHSS (6-24) at the time of recruitment.
• Patients who are not eligible for thrombolysis or thrombectomy.
• Written informed consent by the patient or next-of-kin.

You may not qualify if:

• Patients who are medically unfit such as those who are haemodynamically unstable or whose general condition is deteriorating.
• Patients with transient ischemic attack (TIA).
• Patients who have been diagnosed with malignancy (past or present) or primary haematological disorders.
• Patients who have renal impairment with serum creatinine more than 200 µmol/l or creatinine clearance less than 30 ml/min.
• Patients who have liver impairment with serum aspartate transaminase (AST) and alanine aminotransferase (ALT) two times greater than upper normal limit.
• Patients who are pregnant or are breastfeeding.
• Patients diagnosed with brain hemorrhage or other pathological brain disorders such as vascular malformation (brain arteriovenous malformation), tumor, abscess, cardiogenic, inflammatory and infectious cerebral embolism or other common non- ischemic brain diseases, or diagnosed with severe brain atrophy, as determined by CT or MRI scans.
• Patients diagnosed/suspected diagnosis with acute coronary syndrome.
• Patients with congestive cardiac failure.
• Patients with history of confirmed or suspected pulmonary embolism or chronic obstructive pulmonary disease (COPD).
• Patients with mental, cognitive or psychological disorders that affects their understanding and adherence to research procedures and follow-ups.
• Patients that are undergoing experimental drug or instrument testing or have participated in other clinical drug trials in the past 3 months.

Sponsors & Collaborators

• Cytopeutics Sdn. Bhd.: lead
• National University of Malaysia: collaborator

Study Sites (1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wan Nur Nafisah Wan Yahya

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sze Piaw Chin

CONTACT

+603-8688 1098; operation@cytopeutics.com

Nik Syazana Saffery

CONTACT

+6016-2192675; niksyazana@cytopeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 13, 2023
• Study Start: December 19, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)