NCT06129175RecruitingPhase 2/3
UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX)
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
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 12 Oct 2023
- Start date
- 19 Dec 2023
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Cytopeutics Sdn. Bhd.
- Diseases
- Stroke
- NCT number
- NCT06129175
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 80
- From 19 Dec 2023 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that are undergoing experimental drug or instrument testing or have participated in other clinical drug trials in the past 3 months.
Other illness
- 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.
Lab values
- 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.
Other
- Patients with transient ischemic attack (TIA).
- Patients who are pregnant or are breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Canselor Tuanku Muhriz UKM Coordinator of this site? Confirm its status | Cheras | Malaysia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.