UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX)
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
| Condition(s) | Acute Ischemic Stroke |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 wh |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Cytopeutics Sdn. Bhd. |
| Locations | Cheras, Kuala Lumpur, Malaysia |
| Start date | 2023-12-19 |
| NCT ID | NCT06129175 |
| Official listing | https://clinicaltrials.gov/study/NCT06129175 |