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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):
RNL Bio Company Ltd.
ClinicalTrials.gov Identifier:
NCT01309061
First received: March 2, 2011
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Progressive Hemifacial Atrophy
Romberg's Disease
 Procedure: Autologous Adipose Tissue derived MSCs Transplantation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)

Further study details as provided by RNL Bio Company Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 5
Study Start Date: March 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Autologous Adipose Tissue derived MSCs Transplantation
    Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309061

Locations
Korea, Republic of
ASAN Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
RNL Bio Company Ltd.
Asan Medical Center
Investigators
Principal Investigator: Jong-Woo Choi, M.D.Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: RNL Bio Company Ltd.
ClinicalTrials.gov Identifier: NCT01309061     History of Changes
Other Study ID Numbers: RB-Facial-Stem
Study First Received: March 2, 2011
Last Updated: May 24, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Facial Hemiatrophy
Atrophy
Mouth Diseases
Stomatognathic Diseases
 Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013