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

This study has been completed.
Asan Medical Center
Information provided by (Responsible Party):
Biostar Identifier:
First received: March 2, 2011
Last updated: March 24, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Progressive Hemifacial Atrophy
Romberg's Disease
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)

Resource links provided by NLM:

Further study details as provided by Biostar:

Primary Outcome Measures:
  • The volume change of fatty layer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the volume change of fatty layer using 3D camera.

Secondary Outcome Measures:
  • Clinical lab tests [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To assess the expression change of growth factors after tissue biopsy.

  • Fat absorption rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To estimate the fat absorption rate using 3D computerized tomography and 3D camera.

Enrollment: 5
Study Start Date: March 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Autologous Adipose Tissue derived MSCs Transplantation
    Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01309061

Korea, Republic of
ASAN Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Jong-Woo Choi, M.D.Ph.D. Asan Medical Center
  More Information

Responsible Party: Biostar Identifier: NCT01309061     History of Changes
Other Study ID Numbers: KSC-Facial-Stem 
Study First Received: March 2, 2011
Last Updated: March 24, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Facial Hemiatrophy
Cranial Nerve Diseases
Facial Nerve Diseases
Mouth Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Stomatognathic Diseases processed this record on May 22, 2016