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

Primary Purpose

Stroke

Status

Completed

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

ADSCs

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gwo Xi Stem Cell Applied Technology Co., Ltd.
Hualien Tzu Chi Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GXNPC1

Arm Description

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.

Outcomes

Primary Outcome Measures

Neurological function

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02813512

First Posted

June 3, 2016

Last Updated

December 6, 2018

Sponsor

Gwo Xi Stem Cell Applied Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02813512

Brief Title

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

Official Title

Adipose-Derived Stem Cells (ADSCs) Injections for Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

October 19, 2017 (Actual)

Primary Completion Date

November 27, 2018 (Actual)

Study Completion Date

November 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gwo Xi Stem Cell Applied Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GXNPC1

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ADSCs

Other Intervention Name(s)

hADSCs

Intervention Description

Autologous ADSCs

Primary Outcome Measure Information:

Title

Neurological function

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hualien T Hospital

Organizational Affiliation

Hualien Tzu Chi General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gwo Xi Stem Cell Applied Technology Co., Ltd.

City

Hsinchu

ZIP/Postal Code

30261

Country

Taiwan

Facility Name

Hualien Tzu Chi Hospital

City

Hualien city

ZIP/Postal Code

97002

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34644444

Citation

Chiu TL, Baskaran R, Tsai ST, Huang CY, Chuang MH, Syu WS, Harn HJ, Lin YC, Chen CH, Huang PC, Wang YF, Chuang CH, Lin PC, Lin SZ. Intracerebral transplantation of autologous adipose-derived stem cells for chronic ischemic stroke: A phase I study. J Tissue Eng Regen Med. 2022 Jan;16(1):3-13. doi: 10.1002/term.3256. Epub 2021 Oct 21.

Results Reference

derived

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

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