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

December 6, 2018 updated by: Gwo Xi Stem Cell Applied Technology Co., Ltd.

Adipose-Derived Stem Cells (ADSCs) Injections for Stroke

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 30261
        • Gwo Xi Stem Cell Applied Technology Co., Ltd.
      • Hualien city, Taiwan, 97002
        • Hualien Tzu Chi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological function
Time Frame: 6 months
Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 19, 2017

Primary Completion (ACTUAL)

November 27, 2018

Study Completion (ACTUAL)

November 27, 2018

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (ESTIMATE)

June 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2018

Last Update Submitted That Met QC Criteria

December 6, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH102-REC1-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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