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

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ClinicalTrials.gov Identifier: NCT01309061
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : March 26, 2014
Asan Medical Center
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Progressive Hemifacial Atrophy Romberg's Disease Procedure: Autologous Adipose Tissue derived MSCs Transplantation Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : March 2008
Primary Completion Date : December 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. The volume change of fatty layer [ Time Frame: 24 weeks ]
    To evaluate the volume change of fatty layer using 3D camera.

Secondary Outcome Measures :
  1. Clinical lab tests [ Time Frame: 24 weeks ]
    To assess the expression change of growth factors after tissue biopsy.

  2. Fat absorption rate [ Time Frame: 24 weeks ]
    To estimate the fat absorption rate using 3D computerized tomography and 3D camera.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Biostar
ClinicalTrials.gov Identifier: NCT01309061     History of Changes
Other Study ID Numbers: KSC-Facial-Stem
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Facial Hemiatrophy
Pathological Conditions, Anatomical
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases