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

Phase 1

Completed

• Conditions: Stroke
• Interventions: Drug: ADSCs

• Registration Number: NCT02813512
• Lead Sponsor: Gwo Xi Stem Cell Applied Technology Co., Ltd.

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 Timeline

• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Study Start: 2017-10-19
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GXNPC1	ADSCs	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.

Primary Outcome Measures

Name	Time	Method
Neurological function	6 months	Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)

Trial Locations

Locations (2)

Hualien Tzu Chi Hospital; 🇨🇳 Hualien city, Taiwan

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