MedDataX Logo

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

NCT ID: NCT02813512

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-19

Study Completion Date

2018-11-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

ADSCs

Intervention Type DRUG

Autologous ADSCs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADSCs

Autologous ADSCs

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

hADSCs

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gwo Xi Stem Cell Applied Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hualien T Hospital

Role: PRINCIPAL_INVESTIGATOR

Hualien Tzu Chi General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Hsinchu, , Taiwan

Site Status

Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34644444 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMUH102-REC1-034

Identifier Type: -

Identifier Source: org_study_id