Trial | NCT02813512  Report issue

Title

Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
Adipose-Derived Stem Cells (ADSCs) Injections for Stroke

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3
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).
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 Started
Oct 19
2017
Primary Completion
Nov 27
2018
Study Completion
Nov 27
2018
Last Update
Dec 07
2018

Drug ADSCs

Autologous ADSCs

  • Other names: hADSCs

GXNPC1 Experimental

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.

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
No Results Posted