A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke

Early Phase 1

• Conditions: Stroke, Ischemic
• Interventions: Biological: Induction of neural stem cells

• Registration Number: NCT03725865
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Last Update Submitted: 2018-10-29
• Study First Posted: 2018-10-31
• Last Update Posted: 2018-10-31
• Study Start: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
iNSC treatment group	Induction of neural stem cells	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent AE	1 year