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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.

Tracking Information
First Submitted Date  ICMJE June 3, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date December 7, 2018
Actual Study Start Date  ICMJE October 19, 2017
Actual Primary Completion Date November 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
Neurological function [ Time Frame: 6 months ]
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
Official Title  ICMJE Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Drug: ADSCs
Autologous ADSCs
Other Name: hADSCs
Study Arms  ICMJE 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.
Intervention: Drug: ADSCs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2016)
3
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 27, 2018
Actual Primary Completion Date November 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813512
Other Study ID Numbers  ICMJE CMUH102-REC1-034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gwo Xi Stem Cell Applied Technology Co., Ltd.
Study Sponsor  ICMJE Gwo Xi Stem Cell Applied Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hualien T Hospital Hualien Tzu Chi General Hospital
PRS Account Gwo Xi Stem Cell Applied Technology Co., Ltd.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP