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

NCT ID: NCT01649700

Last Updated: 2014-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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The Sequelae Caused by Severe Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal stem cells treatment

All subjects will receive autologous adipose-derived mesenchymal stem cells

Group Type EXPERIMENTAL

autologous adipose-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Oscar Kuang-Sheng Lee

Director of Stem Cell Research Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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SB-VGH-201101

Identifier Type: -

Identifier Source: org_study_id

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