Using umbilical cord stem cells to treat acute ischemic stroke

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

This study is testing whether giving umbilical cord stem cells to people who have had an acute ischemic stroke can help them recover better and improve their overall health.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cytopeutics Sdn. Bhd. (Industry-sponsored)
• Locations: 1 site (Cheras, Kuala Lumpur)
• Trial ID: NCT06129175 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of intravenous infusion of allogeneic umbilical cord mesenchymal stem cells (Neuroncell-EX) in patients with acute ischemic stroke. It aims to assess functional recovery using the Barthel index and modified Rankin Scale, while also monitoring survival rates and inflammatory responses over one year. The study involves 80 participants and employs a double-blind, randomized controlled design to ensure robust results. The research builds on previous findings that suggest mesenchymal stem cells can alleviate neurological deficits in stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute ischemic stroke within the last four weeks and have moderate to severe symptoms.

Not a fit: Patients who are medically unfit, have transient ischemic attacks, or have significant renal or liver impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: Previous studies have shown promising results with mesenchymal stem cell therapies in stroke treatment, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who are medically unfit such as those who are haemodynamically unstable or whose general condition is deteriorating.
2. Patients with transient ischemic attack (TIA).
3. Patients who have been diagnosed with malignancy (past or present) or primary haematological disorders.
4. Patients who have renal impairment with serum creatinine more than 200 µmol/l or creatinine clearance less than 30 ml/min.
5. Patients who have liver impairment with serum aspartate transaminase (AST) and alanine aminotransferase (ALT) two times greater than upper normal limit.
6. Patients who are pregnant or are breastfeeding.
7. 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.
8. Patients diagnosed/suspected diagnosis with acute coronary syndrome.
9. Patients with congestive cardiac failure.
10. Patients with history of confirmed or suspected pulmonary embolism or chronic obstructive pulmonary disease (COPD).
11. Patients with mental, cognitive or psychological disorders that affects their understanding and adherence to research procedures and follow-ups.
12. Patients that are undergoing experimental drug or instrument testing or have participated in other clinical drug trials in the past 3 months.

Where this trial is running

Cheras, Kuala Lumpur

• Hospital Canselor Tuanku Muhriz UKM — Cheras, Kuala Lumpur, Malaysia (Recruiting)

Study contacts

• Principal investigator: Wan Nur Nafisah Wan Yahya — National University of Malaysia
• Study coordinator: Sze Piaw Chin

Conditions Acute Ischemic Stroke; Mesenchymal stem cells