search
Back to results

Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells

Primary Purpose

The Sequelae Caused by Severe Brain Injury

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
autologous adipose-derived mesenchymal stem cells
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Sequelae Caused by Severe Brain Injury

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).
  • Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.
  • Subject's modified Rankin scale (mRS) grades IV~V.
  • Ages between 20~40 years.
  • Estimated life expectancy must be greater than 2 months.
  • Signed informed consent from the subject.

Exclusion Criteria:

  • Pregnancy test positive.
  • Subject infected with hepatitis C, HIV or syphilis.
  • Subject not suitable for liposuction surgery.
  • Subject not eligible for PET or MRI.
  • Subject enrolled in any other cell therapy studies within the past 30 days.
  • Subject deemed to be not suitable for the study by the investigator.

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal stem cells treatment

Arm Description

All subjects will receive autologous adipose-derived mesenchymal stem cells

Outcomes

Primary Outcome Measures

Safety evaluation
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).

Secondary Outcome Measures

Positron emission tomography
18F-FDG used for the assessment of glucose metabolism in the brain
Magnetic Resonance Imaging
changes in the volume of brain lesions
Electroencephalogram
improvement of continuous slow-waves and irritative features
Neuropsychological assessment
Electrodiagnostic Testing
improvement of subjects' sensory neurologic pathways
Assessment of language and swallowing functions
changes in levels of severity: normal/slight/mild/moderate/severe
Measure of the severity of disability
Assessment of spasticity and strength
Assessment of brain motor control
measurement of the electrical activities in the muscles during specific testing procedures

Full Information

First Posted
April 9, 2012
Last Updated
September 11, 2014
Sponsor
National Yang Ming University
search

1. Study Identification

Unique Protocol Identification Number
NCT01649700
Brief Title
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Official Title
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Sequelae Caused by Severe Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cells treatment
Arm Type
Experimental
Arm Description
All subjects will receive autologous adipose-derived mesenchymal stem cells
Intervention Type
Biological
Intervention Name(s)
autologous adipose-derived mesenchymal stem cells
Intervention Description
Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells.
Primary Outcome Measure Information:
Title
Safety evaluation
Description
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Positron emission tomography
Description
18F-FDG used for the assessment of glucose metabolism in the brain
Time Frame
13 months
Title
Magnetic Resonance Imaging
Description
changes in the volume of brain lesions
Time Frame
16 months
Title
Electroencephalogram
Description
improvement of continuous slow-waves and irritative features
Time Frame
16 months
Title
Neuropsychological assessment
Time Frame
16 months
Title
Electrodiagnostic Testing
Description
improvement of subjects' sensory neurologic pathways
Time Frame
16 months
Title
Assessment of language and swallowing functions
Description
changes in levels of severity: normal/slight/mild/moderate/severe
Time Frame
16 months
Title
Measure of the severity of disability
Time Frame
16 months
Title
Assessment of spasticity and strength
Time Frame
16 months
Title
Assessment of brain motor control
Description
measurement of the electrical activities in the muscles during specific testing procedures
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation). Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage. Subject's modified Rankin scale (mRS) grades IV~V. Ages between 20~40 years. Estimated life expectancy must be greater than 2 months. Signed informed consent from the subject. Exclusion Criteria: Pregnancy test positive. Subject infected with hepatitis C, HIV or syphilis. Subject not suitable for liposuction surgery. Subject not eligible for PET or MRI. Subject enrolled in any other cell therapy studies within the past 30 days. Subject deemed to be not suitable for the study by the investigator.
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells

We'll reach out to this number within 24 hrs