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)
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 2, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedJune 5, 2019
June 1, 2019
1.8 years
March 2, 2011
June 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The volume change of fatty layer
To evaluate the volume change of fatty layer using 3D camera.
24 weeks
Secondary Outcomes (2)
Clinical lab tests
24 weeks
Fat absorption rate
24 weeks
Interventions
Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Biolead
- Asan Medical Centercollaborator
Study Sites (1)
ASAN Medical Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 22907186RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong-Woo Choi, M.D.Ph.D.
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2011
First Posted
March 4, 2011
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
June 5, 2019
Record last verified: 2019-06