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NCT Number: NCT02813512

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gwo Xi Stem Cell Applied Technology Co., Ltd., Hsinchu, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADSCs

Drug

Autologous ADSCs

Other names: hADSCs

Primary outcomes

  1. Neurological function

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Industry

Registry information

Official study title

Adipose-Derived Stem Cells (ADSCs) Injections for Stroke

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2016
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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