NCT01649700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1.6 years

First QC Date

April 9, 2012

Last Update Submit

September 11, 2014

Conditions

The Sequelae Caused by Severe Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Safety evaluation

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

    16 months

Secondary Outcomes (9)

  • Positron emission tomography

    13 months

  • Magnetic Resonance Imaging

    16 months

  • Electroencephalogram

    16 months

  • Neuropsychological assessment

    16 months

  • Electrodiagnostic Testing

    16 months

  • +4 more secondary outcomes

Study Arms (1)

Mesenchymal stem cells treatment

EXPERIMENTAL

All subjects will receive autologous adipose-derived mesenchymal stem cells

Biological: autologous adipose-derived mesenchymal stem cells

Interventions

autologous adipose-derived mesenchymal stem cellsBIOLOGICAL

Patients will receive five infusions, one month apart, each comprising 5-7x10\^7 cells of autologous adipose-derived mesenchymal stem cells.

Mesenchymal stem cells treatment

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Stem Cell Research Centre

Study Record Dates

First Submitted

April 9, 2012

First Posted

July 25, 2012

Study Start

October 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

TW(1)