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| Name | Class |
|---|---|
| Linfen Central Hospital | UNKNOWN |
| Peking University Third Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Beijing Tiantan Hospital |
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This is a multicenter, randomized, double-blind, placebo-controlled, dose-Escalation clinical study to investigate the safety and efficacy of EPCs transplantation in Acute ischemic stroke.
Acute ischemic stroke (AIS) occurs when blood flow to the brain is blocked by a clot or mechanical event and is the most common type of stroke. However, due to the limitation of time and contraindications, only a few patients with AIS are eligible candidates. Endothelial progenitor cells (EPCs) have the potential to reduce brain damage from AIS. They can effectively repair endothelial cells with vascular injuries by directly differentiating into endothelial cells or releasing corresponding regulatory factors, which is a potentially important means for the prevention and treatment of a series of vascular system disorders. The introduction of induced pluripotent stem cells (iPSCs) technology provides a highly feasible option for clinical application of EPCs. Allogeneic iPSC-EPCs can be produced on a large scale to provide enough cells, fundamentally solving the problem of insufficient dosage, and making them a feasible clinical option for treatment of AIS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cohort 1 | Experimental | 1X level dose of iEPCs |
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| Experimental: Cohort 2 | Experimental | 3X level dose of iEPCs or placebo |
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| Experimental: Cohort 3 | Experimental | 6X level dose iEPCs or Placebo |
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| Experimental: Cohort 4 | Experimental | 10X level dose of iEPCs or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iEPCs | Drug | Patients receive iEPCs IV with the single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Incidence and severity of adverse events after iEPCs infusion | Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after iEPCs infusion. | baseline to 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| HLA matching | the level of HLA matching pairs of donor/recipient | From enrollment to the end of treatment at 1 year |
| plasma HLA antibody | The change from the baseline of plasma HLA antibody will be calculated at Day 14,month 1, month 3 post infusion, as available. |
Inclusion Criteria:
Exclusion Criteria:
7. severe respiratory disease that, as assessed by the investigator, may have an impact on the subject's determination of test results (active tuberculosis, chronic obstructive pulmonary disease, interstitial lung disease, severe or critical pneumonia); 8. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg) after treatment, which in the judgment of the investigator carries a high risk of bleeding and has a poor prognosis; 9. Those with malignant tumors or a history of malignant tumors; 10. Have an autoimmune disease or are undergoing immunotherapy; 11. Being pregnant or breastfeeding; 12. Allergic to multiple drugs (≥2) or allergic to human albumin; 13. have been alcohol- or drug-dependent in the 6 months prior to the onset of illness or have had an episode of acute alcoholism in the 24 h prior to the onset of illness or have had an episode of Those with acute alcohol intoxication within 24 h; 14. History of psychiatric illness or severe cognitive impairment that may affect the evaluation of neurologic function; 15. Positive for Hepatitis B surface antigen, positive for Hepatitis C virus antibody, positive for syphilis serum antibody or positive for HIV antibody; 16. Being enrolled in a clinical study of another drug; 17. Patients who, in the opinion of the investigator, are not suitable for participation in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allife Medicine (Beijing) Limitied | Beijing | Beijing Municipality | 100053 | China | ||
| Allife |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
| Linyi People's Hospital | OTHER |
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| Placebo | Drug | Patients receive placebo IV with a single dose |
|
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| From enrollment to the end of treatment at 14 days, 1 month and 3 months |
| plasma T lymphocytes | The change from the baseline in plasma T lymphocytes will be calculated at day 1, day 3, day 7, day 14, day 21, month 1, month 3, month 6, month 9, month 12 post infusion, as available. | From enrollment to the end of treatment at 1 day , 3 days, 7 days, 14 days, 21 days, 1 month , 3 months, 6 months, 9 months, 12 months |
| plasma iEPCs | The change from the baseline in plasma iEPCs will be calculated at 30~40 min, day 1, day 3, day 7, day 14, day 21, month 1, month 2, month 3 post infusion, as available. | From enrollment to the end of treatment at 30~40 mins, 1 day, 3 days, 7 days, 14 days, 21 days, 1 month, 2 months, 3 months |
| Modified Rankin Scale, mRS | The change from the baseline in mRS will be calculated at month 1, month 3, month 6, as available. The scale is divided into 7 degrees, from 0 (no deficit) to 6 (dead). | From enrollment to the end of treatment at 1 month, 3 months, 6 months |
| National Institute of Health stroke scale, NIHSS | The change from the baseline in NIHSS will be calculated at month 1, month 3, month 6 post-treatment, as available. The range of scores is from 0 (normal) to 42. | From enrollment to the end of treatment at 1 month, 3 months, 6 months |
| activity of daily living, ADL | The change from the baseline in ADL will be calculated at month 1, month 3, month 6 post-treatment, as available. Every activity will be scored 5 and the range of scores is from 0 (normal) to 5. | From enrollment to the end of treatment at 1 month, 3 months, 6 months |
| cerebral infarct volume | The change from baseline in cerebral infarct volume using MRI will be calculated at day 7, month 6 post-treatment, as available. | From enrollment to the end of treatment at 7 days and 6 months |
| vascular endothelial growth factor, VEGF | Changes of concentration of vascular endothelial growth factor(VEGF)in the serum from the baseline will be calculated at day 1, day 3, day 7, day 14, day 21, month 1, month 3, month 6, month 9, month 12 post-treatment, as available. | From enrollment to the end of treatment at 1 day , 3 days, 7 days, 14 days, 21 days, 1 month , 3 months, 6 months, 9 months, 12 months |
| brain derived neurotrophic factor,BDNF | Changes of concentration of brain derived neurotrophic factor (BDNF) in the serum from the baseline will be calculated at day 1, day 3, day 7, day 14, day 21, month 1, month 3, month 6, month 9, month 12 post-treatment, as available. | From enrollment to the end of treatment at 1 day , 3 days, 7 days, 14 days, 21 days, 1 month , 3 months, 6 months, 9 months, 12 months |
| Beijing |
| Beijing Municipality |
| China |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |