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

Primary Purpose

Progressive Hemifacial Atrophy, Romberg's Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous Adipose Tissue derived MSCs Transplantation
Sponsored by
R-Bio
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Hemifacial Atrophy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ASAN Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 2, 2011
Last Updated
June 3, 2019
Sponsor
R-Bio
Collaborators
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01309061
Brief Title
The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
Official Title
Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
Collaborators
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Hemifacial Atrophy, Romberg's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Autologous Adipose Tissue derived MSCs Transplantation
Intervention Description
Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
Primary Outcome Measure Information:
Title
The volume change of fatty layer
Description
To evaluate the volume change of fatty layer using 3D camera.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Clinical lab tests
Description
To assess the expression change of growth factors after tissue biopsy.
Time Frame
24 weeks
Title
Fat absorption rate
Description
To estimate the fat absorption rate using 3D computerized tomography and 3D camera.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Woo Choi, M.D.Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASAN Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22907186
Citation
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.
Results Reference
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The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease

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