A Clinical Study of Intracerebral Transplantation of Human Peripheral Blood Derived Induced Neural Stem Cells for Cerebral Hemorrhagic Stroke

Allife Medical Science and Technology Co., Ltd.0 sites12 target enrollmentMarch 2019

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2019

End Date

March 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Sponsor

Allife Medical Science and Technology Co., Ltd.

Responsible Party

Sponsor

•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
•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.

•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.
•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: