The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease

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

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with progressive hemifacial atrophy.

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Detailed Description

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Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.

With the recent demonstration of MSC homing properties, intramuscular aplications of MSCs to cell-damaged diseases have increased.

In a human clinical trial, five patients who had suffered a progressive hemifacial atrophy( Romberg's disease) were intramuscular administered autologous hAdMSCs (1×10e7 cells/500ul) with autologous microlipoinjection one time.

Conditions

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Progressive Hemifacial Atrophy Romberg's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Autologous Adipose Tissue derived MSCs Transplantation

Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects who understand and sign the consent form for this study.
* Age :18-75, males and females.
* Patients with symptom of hemifacial atrophy but not progress disease.

Exclusion Criteria

* Patients with currently progressive hemifacial atrophy.
* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Subjects who don't understand purpose and method for this study.
* Patients with psychical disorder or drug and alcohol addiction.
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No