Stem Cell Infusion Tested for Recovery After Acute Ischemic Stroke
Tests umbilical cord stem cells against placebo in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX)
Key facts
- Where
- Cheras, MalaysiaSee the site
- Phase
- Phase 2/3
Where in Malaysia
- Hospital Canselor Tuanku Muhriz UKMCheras, MalaysiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cytopeutics Sdn. Bhd.
- Trial code
- NCT06129175
- Record updated
- 2 January 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Patients that are undergoing experimental drug or instrument testing or have participated in other clinical drug trials in the past 3 months; Patients who are medically unfit such as those who are haemodynamically unstable or whose general condition is deteriorating; Patients who have been diagnosed with malignancy (past or present) or primary haematological disorders; 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 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 with transient ischemic attack (TIA); Patients who are pregnant or are breastfeeding.