A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke

NCT03725865 | Unknown Early Phase 1

• 1 other identifier: iNSC-81NK-01
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent AE

  1 year

Study Arms (1)

iNSC treatment group

EXPERIMENTAL

Biological: Induction of neural stem cells

Interventions

Induction of neural stem cells BIOLOGICAL

Brain injection iNSC

iNSC treatment group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 4.
• 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.

You may not qualify if:

• 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:
• Coagulopathy.
• Active or history of malignancy.
• Primary or secondary immune deficiency.
• Persistent MRI artifact or unable to undergo MRI.
• Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject.

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: October 31, 2018

Record last verified: 2018-10