NCT06129175 UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX)
| NCT ID | NCT06129175 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Cytopeutics Sdn. Bhd. |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-19 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2023-12-19 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Wan Nur Nafisah Wan Yahya
PRINCIPAL INVESTIGATOR
National University of Malaysia
Frequently Asked Questions
Who can join the NCT06129175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06129175 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06129175 currently recruiting?
Yes, NCT06129175 is actively recruiting participants. Contact the research team at operation@cytopeutics.com for enrollment information.
Where is the NCT06129175 trial being conducted?
This trial is being conducted at Cheras, Malaysia.
Who is sponsoring the NCT06129175 clinical trial?
NCT06129175 is sponsored by Cytopeutics Sdn. Bhd.. The principal investigator is Wan Nur Nafisah Wan Yahya at National University of Malaysia. The trial plans to enroll 80 participants.
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