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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813512
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Gwo Xi Stem Cell Applied Technology Co., Ltd.

Study Description
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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
Stroke Drug: ADSCs 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
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Study Type : Interventional  (Clinical Trial)
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 : October 19, 2017
Actual Primary Completion Date : November 27, 2018
Actual Study Completion Date : November 27, 2018
Arms and Interventions
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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 Name: hADSCs


Outcome Measures
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Primary Outcome Measures :
  1. Neurological function [ Time Frame: 6 months ]
    Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813512


Locations
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Taiwan
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Hsinchu, Taiwan, 30261
Hualien Tzu Chi Hospital
Hualien city, Taiwan, 97002
Sponsors and Collaborators
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Investigators
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Principal Investigator: Hualien T Hospital Hualien Tzu Chi General Hospital
More Information
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Responsible Party: Gwo Xi Stem Cell Applied Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02813512    
Other Study ID Numbers: CMUH102-REC1-034
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases