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A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke

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ClinicalTrials.gov Identifier: NCT03726814
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Biological: EPC treatment group Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Human Peripheral Blood Derived Induced EPCs for Cerebral Hemorrhagic Stroke
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: EPC treatment group Biological: EPC treatment group
Brain injection EPC




Primary Outcome Measures :
  1. Incidence of Treatment Emergent AE [ Time Frame: 1 year ]
    Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Allife Medical Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03726814     History of Changes
Other Study ID Numbers: EPC-BJYY-01
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases