Status:
RECRUITING
UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX)
Lead Sponsor:
Cytopeutics Sdn. Bhd.
Collaborating Sponsors:
National University of Malaysia
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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-...
Detailed Description
Background: Ischemic stroke is a serious cerebrovascular disease with high morbidity and disability worldwide. Despite the great efforts that have been made, the prognosis of stroke patients remains u...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06129175
Start Date
December 19 2023
End Date
December 31 2026
Last Update
January 2 2026
Active Locations (1)
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1
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia, 56000