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Completed

NCT Number: NCT01309061

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

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.

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Key information

Conditions

Progressive Hemifacial Atrophy Cranial Nerve Diseases Facial Hemiatrophy Facial Nerve Diseases Mouth Diseases Nervous System Diseases Romberg's Disease Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASAN Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Adipose Tissue derived MSCs Transplantation

Procedure

Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml

Primary outcomes

  1. The volume change of fatty layer

    Time frame: 24 weeks

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

Secondary outcomes

  1. Clinical lab tests

    Time frame: 24 weeks

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

  2. Fat absorption rate

    Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Collaborators

  • Asan Medical Center

Registry information

Official study title

Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 4, 2011
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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