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

Romberg's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309061
• Other study ID #: KSC-Facial-Stem
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: February 2010

Study information

• Verified date: June 2019
• Source: R-Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Progressive Hemifacial Atrophy
• Romberg's Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	ASAN Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
R-Bio	Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 techniq — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The volume change of fatty layer	To evaluate the volume change of fatty layer using 3D camera.	24 weeks
Secondary	Clinical lab tests	To assess the expression change of growth factors after tissue biopsy.	24 weeks
Secondary	Fat absorption rate	To estimate the fat absorption rate using 3D computerized tomography and 3D camera.	24 weeks