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A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke

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ClinicalTrials.gov Identifier: NCT03725865
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Allife Medical Science and Technology Co., Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Biological: Induction of neural stem cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Intracerebral Transplantation of Human Peripheral Blood Derived Induced Neural Stem Cells for Cerebral Hemorrhagic Stroke
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: iNSC treatment group Biological: Induction of neural stem cells
Brain injection iNSC




Primary Outcome Measures :
  1. Incidence of Treatment Emergent AE [ Time Frame: 1 year ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study procedures.
  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:

  1. Any disabling psychological or psychiatric disorders which may confound the study.
  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.

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Responsible Party: Allife Medical Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03725865     History of Changes
Other Study ID Numbers: iNSC-81NK-01
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases