A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke
NCT ID: NCT03725865
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
12 participants
INTERVENTIONAL
2019-03-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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iNSC treatment group
Induction of neural stem cells
Brain injection iNSC
Interventions
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Induction of neural stem cells
Brain injection iNSC
Eligibility Criteria
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Inclusion Criteria
2. Men and women 30-65 years old.
3. Women must have a negative serum pregnancy test, gestation age women practice an acceptable method of contraception.
4. At least 12 months but no more than 60 months from time of hemorrhagic stroke, with a motor neurological deficit.
5. Documented history of single hemorrhagic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI.
6. Modified Rankin Score of 2, 3 or 4.
7. 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.
8. Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4 point change in the NIHSS.
9. Able and willing to undergo post-physical therapy/rehabilitation.
Exclusion Criteria
2. History of more than one hemorrhagic stroke.
3. History of another major neurological disease or injury.
4. Cerebral soften lesion size \>5cm in any one measurement.
5. Myocardial infarction within the prior 3 months.
6. History of seizures or current use of antiepileptic medication.
7. History of peripheral nerve surgery, including Selective Dorsal Rhizotomy and Contralateral Seventh Cervical Nerve Transfer.
8. Receipt of any investigational drug or device within 30 days.
9. Receipt of any cell infusion other than blood transfusion.
10. Any concomitant medical disease or condition noted below:
1. Coagulopathy.
2. Active or history of malignancy.
3. Primary or secondary immune deficiency.
4. Persistent MRI artifact or unable to undergo MRI.
11. Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject.
12. Any condition that the surgeon feels may pose complications for the surgery.
30 Years
65 Years
ALL
No
Sponsors
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Allife Medical Science and Technology Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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iNSC-81NK-01
Identifier Type: -
Identifier Source: org_study_id