The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
|Progressive Hemifacial Atrophy Romberg's Disease||Procedure: Autologous Adipose Tissue derived MSCs Transplantation||Phase 2|
|Study Design:||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)|
- The volume change of fatty layer [ Time Frame: 24 weeks ]To evaluate the volume change of fatty layer using 3D camera.
- Clinical lab tests [ Time Frame: 24 weeks ]To assess the expression change of growth factors after tissue biopsy.
- Fat absorption rate [ Time Frame: 24 weeks ]To estimate the fat absorption rate using 3D computerized tomography and 3D camera.
|Study Start Date:||March 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309061
|Korea, Republic of|
|ASAN Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Jong-Woo Choi, M.D.Ph.D.||Asan Medical Center|