A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke

October 29, 2018 updated by: Allife Medical Science and Technology Co., Ltd.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Treatment Emergent AE
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allife Medical Science and Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iNSC-81NK-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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