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

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.

Study Overview

• Status: Completed
• Conditions: The Sequelae Caused by Severe Brain Injury
• Intervention / Treatment: Biological: autologous adipose-derived mesenchymal stem cells

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesenchymal stem cells treatment; All subjects will receive autologous adipose-derived mesenchymal stem cells	Biological: autologous adipose-derived mesenchymal stem cells; Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positron emission tomography	18F-FDG used for the assessment of glucose metabolism in the brain	13 months
Magnetic Resonance Imaging	changes in the volume of brain lesions	16 months
Electroencephalogram	improvement of continuous slow-waves and irritative features	16 months
Neuropsychological assessment		16 months
Electrodiagnostic Testing	improvement of subjects' sensory neurologic pathways	16 months
Assessment of language and swallowing functions	changes in levels of severity: normal/slight/mild/moderate/severe	16 months
Measure of the severity of disability		16 months
Assessment of spasticity and strength		16 months
Assessment of brain motor control	measurement of the electrical activities in the muscles during specific testing procedures	16 months

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 9, 2012
• First Submitted That Met QC Criteria: July 22, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): September 12, 2014
• Last Update Submitted That Met QC Criteria: September 11, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: SB-VGH-201101