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

Not Applicable

Completed

• Conditions: Progressive Hemifacial Atrophy; Romberg's Disease

• Registration Number: NCT01309061
• Lead Sponsor: R-Bio

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The volume change of fatty layer	24 weeks	To evaluate the volume change of fatty layer using 3D camera.

Secondary Outcome Measures

Name	Time	Method
Clinical lab tests	24 weeks	To assess the expression change of growth factors after tissue biopsy.
Fat absorption rate	24 weeks	To estimate the fat absorption rate using 3D computerized tomography and 3D camera.

Trial Locations

Locations (1)

ASAN Medical Center; 🇰🇷 Seoul, Korea, Republic of