A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke

Early Phase 1

• Conditions: Stroke, Ischemic
• Interventions: Biological: EPC treatment group

• Registration Number: NCT03726814
• Lead Sponsor: Allife Medical Science and Technology Co., Ltd.

Brief Summary

This is a single centre、single arm、open-label，to investigate the safety and efficacy of EPC transplantation in the brain

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of transplantation EPCs intervent subjests with cerebral hemorrhagic stroke.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Last Update Submitted: 2018-10-30
• Study First Posted: 2018-11-01
• Last Update Posted: 2018-11-01
• Study Start: 2018-12
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Subjects ≥ 18 and ≤ 80 years of age

2. Subjects was confirmed cerebral hemorrhagic stroke, included at least one of risk factors(Hypertension, diabetes, coronary heart disease, high blood lipid), and Satisfied with one of the following conditions:

   A. Significant stenosis (> 50%) of the intracranial and extracranial arteries or their branches due to atherosclerosis, or clinical or imaging manifestations of vascular blockage B. Head imaging (CT or MRI) : cerebral hemispheric infarct lesion diameter of > 1.5cm; Or there were more than 2 discontinuous lesions in the blood supply area of the same intracranial external artery.

   C. Auxiliary examination: color ultrasonography, CTA, MRA or DSA of the blood vessels in the neck confirmed that the intracranial or extracranial stenosis was greater than or equal to 50%；

3. Serum creatinine ≤ 1.5 mg/dl ； Serum ALT/AST）≤2.5×ULN；ALB≥25g/L；

4. Serum creatinine≤ 176.8umol/L（2.0 mg/dl）；

5. Prothrombin time（PT）≤15s，International standardization rates（INR）<1.7；

6. The glucose should be control between 2.8~22.2mmol/L（50~400mg/dl）；

7. Adult patients were willing to use reliable contraceptives (such as condoms) and not to donate sperm throughout the study period and within three months of discharge

8. Subjects and the guardians able to undergo post-physical therapy/rehabilitation

Exclusion Criteria

1. Non-atherogenic cerebral infarction: cardiogenic embolization, small artery occlusion type IS, other exact etiology IS, and unknown etiology IS
2. Combined with cerebral hemorrhage or previous intracranial external blood history, arteriovenous malformation and aneurysm history, or prone to hemorrhage (platelet count below 100 x 109/L)
3. The vital signs of subjects are not stable
4. Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
5. At rest systolic pressure of 170mmHg or diastolic pressure of 105mmHg, or other indications of uncontrolled hypertension
6. Subjects have one kinds of tumors within 5 years
7. The subject was suffering from neurological or mental illness
8. Subjects had congenital or acquired immune deficiencies, active tuberculosis and other active infections (e.g., pulmonary infection, urinary tract infection, skin infection)
9. alcoholics
10. Receipt of any investigational drug or device within 3 month
11. Active hepatitis B (HBV DNA>1000copy/mL), hepatitis C or HIV infection
12. Subjects who have other conditions that were not appropriate for the group determined by the researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EPC treatment group	EPC treatment group	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent AE	1 year	Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment