Progressive Hemifacial AtrophyNCT01309061
The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
A study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Progressive Hemifacial Atrophy and Romberg's Disease, run by R-Bio at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Progressive Hemifacial Atrophy, Romberg's Disease
- What is being tested?
- Autologous Adipose Tissue derived MSCs Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(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.
Read the 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.
- Conditions
- Progressive Hemifacial Atrophy, Romberg's Disease
- Being tested
- Autologous Adipose Tissue derived MSCs Transplantation
- Medical subject headings
- Facial Hemiatrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Tissue derived MSCs TransplantationProcedure or surgery
Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume change of fatty layer
To evaluate the volume change of fatty layer using 3D camera.
Measured: 24 weeks
Secondary outcomes (2)
Clinical lab tests
To assess the expression change of growth factors after tissue biopsy.
Measured: 24 weeks
Fat absorption rate
To estimate the fat absorption rate using 3D computerized tomography and 3D camera.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progressive Hemifacial AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Responsible party
- Sponsor
- Investigators
- Jong-Woo Choi, M.D.Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309061
- Sponsor's protocol ID
- KSC-Facial-Stem
- Status last verified
- Jun 2019
- First submitted
- 2 Mar 2011
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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 techniques using 3-dimensional computed tomography and 3-dimensional camera. Ann Plast Surg. 2012 Sep;69(3):331-7. doi: 10.1097/SAP.0b013e31826239f0.
PubMed 22907186
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)
- ClinicalTrials.gov ID
- NCT01309061
- Acronym / sponsor ID
- KSC-Facial-Stem
- Conditions
- Progressive Hemifacial Atrophy, Romberg's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- R-BioIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Adipose Tissue derived MSCs TransplantationIntramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml | Procedure or surgery | – |
Primary outcome
The volume change of fatty layer
Time frame: 24 weeks
To evaluate the volume change of fatty layer using 3D camera.
2 secondary outcomes
Clinical lab tests
Time frame: 24 weeks
Fat absorption rate
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Results publication: PubMed 22907186Koh 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 techniques using 3-dimensional computed tomography and 3-dimensional camera. Ann Plast Surg. 2012 Sep;69(3):331-7. doi: 10.1097/SAP.0b013e31826239f0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Woo Choi, M.D.Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Progressive Hemifacial Atrophy and Romberg's Disease, run by R-Bio at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volume change of fatty layer (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01309061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.