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Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke

Sponsor
Gwo Xi Stem Cell Applied Technology Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02813512
Collaborator
(none)
3
Enrollment
2
Locations
1
Arm
13.3
Actual Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects who have chronic non-hemorrhagic stroke (>6 months).

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This open-label clinical trial will compare outcomes of subjects with chronic stroke. Six subjects will be to treatment (n=3) groups. The treatment group will receive brain transplants of autologous ADSCs. Treatment group will receive rehabilitation after the transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and eight standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), ( Barthel Index )、 ( Berg balance scale )、 (Fugl - Meyer test )、(Action research arm test )、 (Purdue pegboard )、 ( grip strength measurement ) 、(somatosensory evoked potential, SSEP) at 1 month, 3 months, and 6 months after treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
Actual Study Start Date :
Oct 19, 2017
Actual Primary Completion Date :
Nov 27, 2018
Actual Study Completion Date :
Nov 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: GXNPC1

Three subjects will be to treatment (n=3) groups. The treatment group will receive brain transplants of autologous ADSCs. Treatment group will receive rehabilitation after the transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and four standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), European Stroke Scale (ESS), European Stroke Motor Subscale (EMS), Barthel Index, MMSE and Gait analyses at 1 month, 3 months, and 6 months after treatment.

Drug: ADSCs
Autologous ADSCs
Other Names:
  • hADSCs

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neurological function [6 months]

      Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • stroke investigators with age 65 to 80 years

    • history of stroke between six months and 10 years

    • Systolic pressure and Diastolic pressure were maintained under 160 mmHg and 110 mmHg

    • INR < 2.5, platelets counts 1-5 x 10^5/μl

    • Damaged area range between 0.5 cm to 6 cm by brain MRI

    Exclusion Criteria:

    • Pregnant women

    • Investigators with AIDS, cancer, liver dysfunction

    • Others can't fit into the trial evaluate by investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gwo Xi Stem Cell Applied Technology Co., Ltd. Hsinchu Taiwan 30261
    2 Hualien Tzu Chi Hospital Hualien city Taiwan 97002

    Sponsors and Collaborators

    • Gwo Xi Stem Cell Applied Technology Co., Ltd.

    Investigators

    • Principal Investigator: Hualien T Hospital, Hualien Tzu Chi General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gwo Xi Stem Cell Applied Technology Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02813512
    Other Study ID Numbers:
    • CMUH102-REC1-034
    First Posted:
    Jun 27, 2016
    Last Update Posted:
    Dec 7, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Dec 7, 2018