Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Progressive Hemifacial Atrophy
- Sponsor
- R-Bio
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- The volume change of fatty layer
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The volume change of fatty layer
Time Frame: 24 weeks
To evaluate the volume change of fatty layer using 3D camera.
Secondary Outcomes
- Clinical lab tests(24 weeks)
- Fat absorption rate(24 weeks)