Back to resultsA Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke
Primary Purpose
Stroke, Ischemic
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
EPC treatment group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic
Eligibility Criteria
Inclusion Criteria:
- Subjects ≥ 18 and ≤ 80 years of age
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%；
- Serum creatinine ≤ 1.5 mg/dl ； Serum ALT/AST）≤2.5×ULN；ALB≥25g/L；
- Serum creatinine≤ 176.8umol/L（2.0 mg/dl）；
- Prothrombin time（PT）≤15s，International standardization rates（INR）<1.7；
- The glucose should be control between 2.8~22.2mmol/L（50~400mg/dl）；
- 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
- Subjects and the guardians able to undergo post-physical therapy/rehabilitation
Exclusion Criteria:
- Non-atherogenic cerebral infarction: cardiogenic embolization, small artery occlusion type IS, other exact etiology IS, and unknown etiology IS
- 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)
- The vital signs of subjects are not stable
- Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
- At rest systolic pressure of 170mmHg or diastolic pressure of 105mmHg, or other indications of uncontrolled hypertension
- Subjects have one kinds of tumors within 5 years
- The subject was suffering from neurological or mental illness
- Subjects had congenital or acquired immune deficiencies, active tuberculosis and other active infections (e.g., pulmonary infection, urinary tract infection, skin infection)
- alcoholics
- Receipt of any investigational drug or device within 3 month
- Active hepatitis B (HBV DNA>1000copy/mL), hepatitis C or HIV infection
- Subjects who have other conditions that were not appropriate for the group determined by the researchers.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EPC treatment group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Treatment Emergent AE
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03726814
First Posted
October 30, 2018
Last Updated
October 30, 2018
Sponsor
Allife Medical Science and Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03726814
Brief Title
A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke
Official Title
A Safety and Efficacy Study of Human Peripheral Blood Derived Induced EPCs for Cerebral Hemorrhagic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allife Medical Science and Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EPC treatment group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
EPC treatment group
Intervention Description
Brain injection EPC
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent AE
Description
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects ≥ 18 and ≤ 80 years of age
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%；
Serum creatinine ≤ 1.5 mg/dl ； Serum ALT/AST）≤2.5×ULN；ALB≥25g/L；
Serum creatinine≤ 176.8umol/L（2.0 mg/dl）；
Prothrombin time（PT）≤15s，International standardization rates（INR）<1.7；
The glucose should be control between 2.8~22.2mmol/L（50~400mg/dl）；
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
Subjects and the guardians able to undergo post-physical therapy/rehabilitation
Exclusion Criteria:
Non-atherogenic cerebral infarction: cardiogenic embolization, small artery occlusion type IS, other exact etiology IS, and unknown etiology IS
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)
The vital signs of subjects are not stable
Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
At rest systolic pressure of 170mmHg or diastolic pressure of 105mmHg, or other indications of uncontrolled hypertension
Subjects have one kinds of tumors within 5 years
The subject was suffering from neurological or mental illness
Subjects had congenital or acquired immune deficiencies, active tuberculosis and other active infections (e.g., pulmonary infection, urinary tract infection, skin infection)
alcoholics
Receipt of any investigational drug or device within 3 month
Active hepatitis B (HBV DNA>1000copy/mL), hepatitis C or HIV infection
Subjects who have other conditions that were not appropriate for the group determined by the researchers.
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke
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