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

B

Biostar Stem Cell Research Institute (R-Bio)

Status

Completed

Conditions

Progressive Hemifacial Atrophy
Romberg's Disease

Treatments

Procedure: Autologous Adipose Tissue derived MSCs Transplantation

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01309061
KSC-Facial-Stem

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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