ScarPhase 1/2NCT02336997
Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
A Phase 1/2 study testing FAT-GRAFT and SVF-TRANSPLANTATION in people with Scar, run by Qing-FengLi Li,MD at 2 sites in China.
Trial summary
The purpose of this study is to evaluating whether autologous grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Scar
- What is being tested?
- FAT-GRAFT and SVF-TRANSPLANTATION
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2015to Dec 2016
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18 to 60 years;
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 80 to 600 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Who cannot join
- Not fit for soft tissue expansion treatment;
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- Significant renal, cardiovascular, hepatic and psychiatric diseases;
- Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
- BMI >30;
- History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
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- History of allogenic bone marrow transplantation;
- Long history of smoking;
- Evidence of malignant diseases or unwillingness to participate.
Trial locations and contacts
2 sites in 1 country.
Qing-Feng Li, M.D., Ph.D. contact
China2 sites, 2 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Qingfeng Li, MD, PhD, 0086 21 63089567, liqfliqf@yahoo.com.cn
Shuangbai Zhou, MD, 0086 13482514585, shuangbaizhou@gmail.com
- Recruiting
Shanghai Ninth People's Hospital
Shanghai
Qing-Feng Li, M.D., Ph.D.
About this study
The purpose of this study is to evaluating whether autologous grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
Read the detailed description
Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. This study is to evaluate the effects of autologous fat graft/SVF transplantation on accelerating skin regeneration and promoting tissue expansion process.
Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into three groups, named as the experimental group and the control group. Patients from the FAT-GRAFT group will have a liposuction and subdermal fat graft transplantation. Patients from the SVF-TRANSPLANTATION group will have a liposuction and SVF will be separated and transplanted intradermally to expanded skin. Patients from the control group will have saline injection.
- Conditions
- Scar
- Being tested
- FAT-GRAFT, SVF-TRANSPLANTATION, PLACEBO
- Keywords
- skin regeneration, mechanical stretch
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAT-GRAFTProcedure or surgery
Liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin at the density of 0.1 ml/cm2.
SVF-TRANSPLANTATIONProcedure or surgery
Liposuction will be performed. SVF will be separated from autologous fat graft by collagenase digestion. Patients will receive resuspended SVF transplantation subdermally to expanded skin at the density of 1*10e6 cells/cm2.
PLACEBOProcedure or surgery
Saline will be injected into expanded skin.
| Study group | Role | What they receive |
|---|---|---|
| FAT-GRAFT | Experimental | Fat graft transplantation Receives: Procedure: FAT-GRAFT |
| SVF-TRANSPLANTATION | Experimental | Transplantation of resuspended SVF Receives: Procedure: SVF-TRANSPLANTATION |
| CONTROL | Placebo comparator | Same volume saline injection Receives: Procedure: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Major Adverse Events
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
Measured: Up to approximately 24 months after study start
To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks
Record the inflation volume of each expander with the maintained inner pressure.
Measured: baseline and 8 weeks post treatment
Secondary outcomes (3)
To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin
Record the outface of expanded skin flap with 3D laser scanner and calculate the surface of expanded skin
Measured: baseline and 8 weeks post treatment
To Measure the Texture of Expanded Flap with VISIA scanner
Evaluate skin texture with VISIA scanner and compare the characteristics
Measured: 4 weeks and 8 weeks post treatment
To Measure Expanded Skin Thickness by Ultrasound Scanning
Measure the dermal and epidermal thickness of expanded skin by ultrasound scanning
Measured: baseline, 4 weeks and 8 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing-FengLi Li,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336997
- Sponsor's protocol ID
- [2014]47
- Status last verified
- Apr 2016
- First submitted
- 26 Dec 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
- ClinicalTrials.gov ID
- NCT02336997
- Acronym / sponsor ID
- [2014]47
- Conditions
- Scar
- Keywords
- skin regeneration, mechanical stretch
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qing-FengLi Li,MDUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 13 Jan 2015 (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 evaluating whether autologous grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
Detailed description
Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. This study is to evaluate the effects of autologous fat graft/SVF transplantation on accelerating skin regeneration and promoting tissue expansion process.
Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into three groups, named as the experimental group and the control group. Patients from the FAT-GRAFT group will have a liposuction and subdermal fat graft transplantation. Patients from the SVF-TRANSPLANTATION group will have a liposuction and SVF will be separated and transplanted intradermally to expanded skin. Patients from the control group will have saline injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FAT-GRAFT | Experimental | Procedure: FAT-GRAFTFat graft transplantation |
| SVF-TRANSPLANTATION | Experimental | Procedure: SVF-TRANSPLANTATIONTransplantation of resuspended SVF |
| CONTROL | Placebo comparator | Procedure: PLACEBOSame volume saline injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age of 18 to 60 years;
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 80 to 600 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
Key exclusion criteria (9 listed)
- Not fit for soft tissue expansion treatment;
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- Significant renal, cardiovascular, hepatic and psychiatric diseases;
- Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
- BMI >30;
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 |
|---|---|---|
| FAT-GRAFTLiposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin at the density of 0.1 ml/cm2. | Procedure or surgery | FAT-GRAFT |
| SVF-TRANSPLANTATIONLiposuction will be performed. SVF will be separated from autologous fat graft by collagenase digestion. Patients will receive resuspended SVF transplantation subdermally to expanded skin at the density of 1*10e6 cells/cm2. | Procedure or surgery | SVF-TRANSPLANTATION |
| PLACEBOSaline will be injected into expanded skin. | Procedure or surgery | CONTROL |
Primary outcome
Occurence of Major Adverse Events
Time frame: Up to approximately 24 months after study start
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks
Time frame: baseline and 8 weeks post treatment
Record the inflation volume of each expander with the maintained inner pressure.
3 secondary outcomes
To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin
Time frame: baseline and 8 weeks post treatment
To Measure the Texture of Expanded Flap with VISIA scanner
Time frame: 4 weeks and 8 weeks post treatment
To Measure Expanded Skin Thickness by Ultrasound Scanning
Time frame: baseline, 4 weeks and 8 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
Qing-Feng Li, M.D., Ph.D. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FAT-GRAFT and SVF-TRANSPLANTATION in people with Scar, run by Qing-FengLi Li,MD at 2 sites in China.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing-Feng Li, M.D., Ph.D. (00862123271699), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of Major Adverse Events (time frame: Up to approximately 24 months after study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2016.