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

Sponsor
R-Bio (Industry)
Overall Status
Completed
CT.gov ID
NCT01309061
Collaborator
Asan Medical Center (Other)
5
Enrollment
1
Location
23.1
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Autologous Adipose Tissue derived MSCs Transplantation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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)
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Feb 1, 2010

Outcome Measures

Primary Outcome Measures

  1. The volume change of fatty layer [24 weeks]

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

Secondary Outcome Measures

  1. Clinical lab tests [24 weeks]

    To assess the expression change of growth factors after tissue biopsy.

  2. Fat absorption rate [24 weeks]

    To estimate the fat absorption rate using 3D computerized tomography and 3D camera.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 ASAN Medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • R-Bio
  • Asan Medical Center

Investigators

  • Principal Investigator: Jong-Woo Choi, M.D.Ph.D., Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
R-Bio
ClinicalTrials.gov Identifier:
NCT01309061
Other Study ID Numbers:
  • KSC-Facial-Stem
First Posted:
Mar 4, 2011
Last Update Posted:
Jun 5, 2019
Last Verified:
Jun 1, 2019
Additional relevant MeSH terms:
Facial Hemiatrophy
Atrophy

Study Results

No Results Posted as of Jun 5, 2019