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
|Condition or disease||Intervention/treatment||Phase|
|Progressive Hemifacial Atrophy Romberg's Disease||Procedure: Autologous Adipose Tissue derived MSCs Transplantation||Phase 2|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||February 2010|
- Procedure: Autologous Adipose Tissue derived MSCs Transplantation
Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
- 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.
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|
|Principal Investigator:||Jong-Woo Choi, M.D.Ph.D.||Asan Medical Center|