CClinicalTrials.gg
Status unknownNCT03726814Updated Nov 1, 2018

A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke

An Early Phase 1 interventional study of EPC treatment group in Stroke, Ischemic, sponsored by Allife Medical Science and Technology Co., Ltd.. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-01.

Sponsored by Allife Medical Science and Technology Co., Ltd. · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
12
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 12 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Allife Medical Science and Technology Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    EPC treatment group

    Biological: EPC treatment group

Interventions

  • BiologicalEPC treatment group

    Brain injection EPC

06

What researchers measure

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

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03726814
Lead sponsor
Allife Medical Science and Technology Co., Ltd.
Responsible party
Sponsor
First posted
Nov 1, 2018
Start date
Dec 2018 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Dec 2020 (estimated)
Last update
Nov 1, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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