Stroke, IschemicEarly Phase 1NCT03725865
A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke
A Early Phase 1 study testing Induction of neural stem cells 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 induction of neural stem cells transplantation in the brain Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Induction of neural stem cells
- 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
- Mar 2019to Mar 2019
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study procedures.
- Men and women 30-65 years old.
- Women must have a negative serum pregnancy test, gestation age women practice an acceptable method of contraception.
- At least 12 months but no more than 60 months from time of hemorrhagic stroke, with a motor neurological deficit.
- Documented history of single hemorrhagic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI.
- Modified Rankin Score of 2, 3 or 4.
Show all 9Show fewer
- FMMS score of 55 or less, two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 5 point change in the FMMS.
- Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4 point change in the NIHSS.
- Able and willing to undergo post-physical therapy/rehabilitation.
Who cannot join
- Any disabling psychological or psychiatric disorders which may confound the study.
- History of more than one hemorrhagic stroke.
- History of another major neurological disease or injury.
- Cerebral soften lesion size >5cm in any one measurement.
- Myocardial infarction within the prior 3 months.
- History of seizures or current use of antiepileptic medication.
Show all 16Show fewer
- History of peripheral nerve surgery, including Selective Dorsal Rhizotomy and Contralateral Seventh Cervical Nerve Transfer.
- Receipt of any investigational drug or device within 30 days.
- Receipt of any cell infusion other than blood transfusion.
- Any concomitant medical disease or condition noted below:
- Coagulopathy.
- Active or history of malignancy.
- Primary or secondary immune deficiency.
- Persistent MRI artifact or unable to undergo MRI.
- Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject.
- Any condition that the surgeon feels may pose complications for the surgery.
About this study
Official title: A Clinical Study of Intracerebral Transplantation of Human Peripheral Blood Derived Induced Neural Stem Cells for Cerebral Hemorrhagic Stroke
This is a single centre、single arm、open-label，to investigate the safety and efficacy of induction of neural stem cells transplantation in the brain
- Conditions
- Stroke, Ischemic
- Being tested
- Induction of neural stem cells
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of neural stem cellsBiological
Brain injection iNSC
| Study group | Role | What they receive |
|---|---|---|
| iNSC treatment group | Experimental | Not described Receives: Biological: Induction of neural stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent AE
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 posted31 Oct 2018
- Study startMar 2019 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (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
- NCT03725865
- Sponsor's protocol ID
- iNSC-81NK-01
- Status last verified
- Oct 2018
- First submitted
- 29 Oct 2018
- Last updated
- 31 Oct 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 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Intracerebral Transplantation of Human Peripheral Blood Derived Induced Neural Stem Cells for Cerebral Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT03725865
- Acronym / sponsor ID
- iNSC-81NK-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
- Mar 2019 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 31 Oct 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 induction of neural stem cells transplantation in the brain
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNSC treatment group | Experimental | Biological: Induction of neural stem cells |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study procedures.
- Men and women 30-65 years old.
- Women must have a negative serum pregnancy test, gestation age women practice an acceptable method of contraception.
- At least 12 months but no more than 60 months from time of hemorrhagic stroke, with a motor neurological deficit.
- Documented history of single hemorrhagic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI.
Key exclusion criteria (16 listed)
- Any disabling psychological or psychiatric disorders which may confound the study.
- History of more than one hemorrhagic stroke.
- History of another major neurological disease or injury.
- Cerebral soften lesion size >5cm in any one measurement.
- Myocardial infarction within the prior 3 months.
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 |
|---|---|---|
| Induction of neural stem cellsBrain injection iNSC | Biological | iNSC treatment group |
Primary outcome
Incidence of Treatment Emergent AE
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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 Induction of neural stem cells 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 9 inclusion and 16 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 31 Oct 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 31 Oct 2018.