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

Stroke Clinical Trial

Official title:

Adipose-Derived Stem Cells (ADSCs) Injections for Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813512
• Other study ID #: CMUH102-REC1-034
• Status: Completed
• Phase: Phase 1
• Start date: October 19, 2017
• Est. completion date: November 27, 2018

Study information

• Verified date: December 2018
• Source: Gwo Xi Stem Cell Applied Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• ADSCs
Autologous ADSCs

Locations

Country	Name	City	State
Taiwan	Gwo Xi Stem Cell Applied Technology Co., Ltd.	Hsinchu
Taiwan	Hualien Tzu Chi Hospital	Hualien city

Sponsors (1)

Lead Sponsor	Collaborator
Gwo Xi Stem Cell Applied Technology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological function	Blood biochemical, Neurobehavioral examination (NIH Stroke Scale 16-20)	6 months