A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke

NCT03726814 | Unknown Early Phase 1

• 1 other identifier: EPC-BJYY-01
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (1)

EPC treatment group

EXPERIMENTAL

Biological: EPC treatment group

Interventions

EPC treatment group BIOLOGICAL

Brain injection EPC

EPC treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: November 1, 2018

Record last verified: 2018-10