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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Dise

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.

Detailed Summary:

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.


Sponsor: Biostar

Current Primary Outcome: The volume change of fatty layer [ Time Frame: 24 weeks ]

To evaluate the volume change of fatty layer using 3D camera.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Biostar

Dates:
Date Received: March 2, 2011
Date Started: March 2008
Date Completion:
Last Updated: March 24, 2014
Last Verified: March 2014