Skin RegenerationNCT07114692
The Effect of Stromal Vascular Fraction Transplantation on the Regeneration of Expanded Skin
A study testing Stromal vascular fraction transplantation and Normal saline injection in people with Skin Regeneration, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial summary
This study is a randomized controlled trial aimed at evaluating the effect of intradermal stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Regeneration
- What is being tested?
- Stromal vascular fraction transplantation and Normal saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: over 18 years and under 65 years;
- show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis;
- Have signed the informed consent form, agree to participate in this study, and are able to comply with follow-up requirements.
Who cannot join
- Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function;
- Patients with a long history of smoking and alcohol use who have not quit smoking or drinking;
- Patients allergic to iodine or iodine-containing preparations;
- Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate;
- Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin;
- Patients with severely loose skin or insufficient subcutaneous fat tissue;
- Patients who request to withdraw informed consent and exit the clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xin Huang, M.D., Ph.D. contact
About this study
Official title: The Effect of Intradermal Stromal Vascular Fraction Transplantation on the Regeneration of Expanded Skin: a Randomized Controlled Trial
This study is a randomized controlled trial aimed at evaluating the effect of intradermal stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.
Read the detailed description
This study is a randomized controlled trial aimed at evaluating the effect of intradermal stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. This study will enroll patients experiencing dermal exhaustion during the process of skin soft tissue expansion. Participants will be randomly assigned in a 1:1 ratio to either the stromal vascular fraction (SVF) transplantation group or the normal saline control group. To confirm eligibility, all potential participants will undergo a baseline screening visit. Those meeting the inclusion criteria will proceed to the study center for enrollment assessment, followed by randomization. Participants in the SVF transplantation group will undergo abdominal liposuction and receive intradermal SVF transplantation. Participants in the control group will receive intradermal injections of an equivalent volume of normal saline. The changes of dermis of expanded skin were recorded before the treatment (baseline), and at 4 weeks and 8 weeks follow-up timepoints after SVF transplantation. More specifically, skin surface area was measured using laser 3D scan; skin thickness and texture were detected by ultrasound, VISIA skin analyzer and CK skin analyzer; skin blood perfusion was analyzed using indocyanine green angiography.
- Conditions
- Skin Regeneration
- Being tested
- Stromal vascular fraction transplantation, Normal saline injection
- Keywords
- skin expansion, stromal vascular fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal vascular fraction transplantationBiological
Subcutaneous fat was harvested from either the abdomen or the posterior inner thigh region and then digested with 600 U of collagenase (Shanghai Qiaoyuan Biological Pharmaceutical Co., Ltd, Shanghai, China) at 37°C and 150rpm for three hours. After enzymatic digestion, the lower aqueous phase liquid was aspirated to acquire the stromal vascular fraction (SVF). The SVF cell-pellet was washed and adjusted to 2×10^6 cells/mL. Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml (around 1×10^6 cells) were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg.
Normal saline injectionBiological
Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml 0.9% normal saline were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Stromal vascular fraction transplantation | Experimental | Subcutaneous fat was harvested from either the abdomen or the posterior inner thigh region and then digested with 600 U of collagenase (Shanghai Qiaoyuan Biological Pharmaceutical Co., Ltd, Shanghai, China) at 37°C and 150rpm for three hours. After enzymatic digestion, the lower aqueous phase liquid was aspirated to acquire the stromal vascular fraction (SVF). The SVF cell-pellet was washed and adjusted to 2×10^6 cells/mL. Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml (around 1×10^6 cells) were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg. Receives: Biological: Stromal vascular fraction transplantation |
| Normal saline injection | Placebo comparator | Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml 0.9% normal saline were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg. Receives: Biological: Normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal thickness
Using Doppler ultrasound to measure the full-thickness of skin dermis of the expanded skin. The measurements were conducted at the center of the expanded skin and other four points (above, below, left, right) around the center. The average value is taken to represent the dermal thickness of the patient's expanded skin.
Measured: Baseline, 4 and 8 weeks after intervention
Secondary outcomes (1)
Skin surface area
Using the HSCAN771 handheld laser 3D scanner and the VIVID910 3D laser scanning system to measure the surface area of the expanded skin.
Measured: baseline, 4 and 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin RegenerationStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zan, MD, Ph.D, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Tao Zan, M.D., Ph.D., Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114692
- Sponsor's protocol ID
- Shanghai9th-SVF-ES-RCT
- Status last verified
- Jun 2025
- First submitted
- 3 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any additional information regarding individual participants is available from the principle investigator of this study upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intradermal Stromal Vascular Fraction Transplantation on the Regeneration of Expanded Skin: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07114692
- Acronym / sponsor ID
- Shanghai9th-SVF-ES-RCT
- Conditions
- Skin Regeneration
- Keywords
- skin expansion, stromal vascular fraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- 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.
This study is a randomized controlled trial aimed at evaluating the effect of intradermal stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.
Detailed description
This study is a randomized controlled trial aimed at evaluating the effect of intradermal stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. This study will enroll patients experiencing dermal exhaustion during the process of skin soft tissue expansion. Participants will be randomly assigned in a 1:1 ratio to either the stromal vascular fraction (SVF) transplantation group or the normal saline control group. To confirm eligibility, all potential participants will undergo a baseline screening visit. Those meeting the inclusion criteria will proceed to the study center for enrollment assessment, followed by randomization. Participants in the SVF transplantation group will undergo abdominal liposuction and receive intradermal SVF transplantation. Participants in the control group will receive intradermal injections of an equivalent volume of normal saline. The changes of dermis of expanded skin were recorded before the treatment (baseline), and at 4 weeks and 8 weeks follow-up timepoints after SVF transplantation. More specifically, skin surface area was measured using laser 3D scan; skin thickness and texture were detected by ultrasound, VISIA skin analyzer and CK skin analyzer; skin blood perfusion was analyzed using indocyanine green angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stromal vascular fraction transplantation | Experimental | Biological: Stromal vascular fraction transplantationSubcutaneous fat was harvested from either the abdomen or the posterior inner thigh region and then digested with 600 U of collagenase (Shanghai Qiaoyuan Biological Pharmaceutical Co., Ltd, Shanghai, China) at 37°C and 150rpm for three hours. After enzymatic digestion, the lower aqueous phase liquid was aspirated to acquire the stromal vascular fraction (SVF). The SVF cell-pellet was washed and adjusted to 2×10^6 cells/mL. Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml (around 1×10^6 cells) were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg. |
| Normal saline injection | Placebo comparator | Biological: Normal saline injectionLidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml 0.9% normal saline were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: over 18 years and under 65 years;
- show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis;
- Have signed the informed consent form, agree to participate in this study, and are able to comply with follow-up requirements.
Key exclusion criteria (7 listed)
- Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function;
- Patients with a long history of smoking and alcohol use who have not quit smoking or drinking;
- Patients allergic to iodine or iodine-containing preparations;
- Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate;
- Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin;
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 |
|---|---|---|
| Stromal vascular fraction transplantationSubcutaneous fat was harvested from either the abdomen or the posterior inner thigh region and then digested with 600 U of collagenase (Shanghai Qiaoyuan Biological Pharmaceutical Co., Ltd, Shanghai, China) at 37°C and 150rpm for three hours. After enzymatic digestion, the lower aqueous phase liquid was aspirated to acquire the stromal vascular fraction (SVF). The SVF cell-pellet was washed and adjusted to 2×10^6 cells/mL. Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml (around 1×10^6 cells) were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg. | Biological | Stromal vascular fraction transplantation |
| Normal saline injectionLidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml 0.9% normal saline were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg. | Biological | Normal saline injection |
Primary outcome
Dermal thickness
Time frame: Baseline, 4 and 8 weeks after intervention
Using Doppler ultrasound to measure the full-thickness of skin dermis of the expanded skin. The measurements were conducted at the center of the expanded skin and other four points (above, below, left, right) around the center. The average value is taken to represent the dermal thickness of the patient's expanded skin.
1 secondary outcome
Skin surface area
Time frame: baseline, 4 and 8 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No. Any additional information regarding individual participants is available from the principle investigator of this study upon reasonable request.
Related trials for Skin Regeneration
Enrolling by invitationPhase 2
Deployment and Evaluation of Humanoid Robotics in Coalition-Aligned Clinical Care Settings
Mobility Impairment, Clinical Workflow Optimization
Recruiting
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
Diabetic Foot Ulcers (DFUs), Diabetic Foot
Recruiting
Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
Burns, Contracture Scar
Recruiting
Autologous Point-of-Care Adipose Therapy: Recent Injury
Burns, Contracture Scar
Not yet recruitingEarly Phase 1
PIEZO-101 First-in-Human Safety and Proof-of-Concept Study
Skin Aging, Wrinkles in Decolletage
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.
Xin Huang, M.D., Ph.D. contact
Tao Zan, M.D., Ph.D. principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Stromal vascular fraction transplantation and Normal saline injection in people with Skin Regeneration, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
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: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohan Lin ((021)23271699 ext. 5576, shjyiec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal thickness (time frame: Baseline, 4 and 8 weeks after intervention). 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 17 Aug 2025.