Stroke, IschemicEarly Phase 1NCT03726814
A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke
A Early Phase 1 study testing EPC treatment group in people with Stroke, Ischemic, run by Allife Medical Science and Technology Co., Ltd..
Trial summary
This is a single centre、single arm、open-label，to investigate the safety and efficacy of EPC transplantation in the brain Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- EPC treatment group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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）；
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- 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
Who cannot join
- 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
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- 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.
About this study
Official title: A Safety and Efficacy Study of Human Peripheral Blood Derived Induced EPCs for Cerebral Hemorrhagic Stroke
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.
- Conditions
- Stroke, Ischemic
- Being tested
- EPC treatment group
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPC treatment groupBiological
Brain injection EPC
| Study group | Role | What they receive |
|---|---|---|
| EPC treatment group | Experimental | Not described Receives: Biological: EPC treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allife Medical Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726814
- Sponsor's protocol ID
- EPC-BJYY-01
- Status last verified
- Oct 2018
- First submitted
- 30 Oct 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Human Peripheral Blood Derived Induced EPCs for Cerebral Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT03726814
- Acronym / sponsor ID
- EPC-BJYY-01
- Conditions
- Stroke, Ischemic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Allife Medical Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPC treatment group | Experimental | Biological: EPC treatment group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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；
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPC treatment groupBrain injection EPC | Biological | EPC treatment group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EPC treatment group in people with Stroke, Ischemic, run by Allife Medical Science and Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent AE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.