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

This study has been completed.
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
K-Stemcell Co Ltd
ClinicalTrials.gov Identifier:
NCT01309061
First received: March 2, 2011
Last updated: March 24, 2014
Last verified: March 2014

March 2, 2011
March 24, 2014
March 2008
December 2009   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01309061 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Progressive Hemifacial Atrophy
  • Romberg's Disease
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
Not Provided
Koh KS, Oh TS, Kim H, Chung IW, Lee KW, Lee HB, Park EJ, Jung JS, Shin IS, Ra JC, Choi JW. Clinical application of human adipose tissue-derived mesenchymal stem cells in progressive hemifacial atrophy (Parry-Romberg disease) with microfat grafting techniques using 3-dimensional computed tomography and 3-dimensional camera. Ann Plast Surg. 2012 Sep;69(3):331-7. doi: 10.1097/SAP.0b013e31826239f0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
February 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01309061
KSC-Facial-Stem
No
K-Stemcell Co Ltd
K-Stemcell Co Ltd
Asan Medical Center
Principal Investigator: Jong-Woo Choi, M.D.Ph.D. Asan Medical Center
K-Stemcell Co Ltd
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP