Skin RegenerationSDR-SVFNCT06439459

Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation

A study testing Stromal vascular fraction transplantation in people with Skin Regeneration, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Skin Regeneration
What is being tested?: Stromal vascular fraction transplantation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteChina
Study dates: 15 Feb 2023to 25 Feb 2024
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

had undergone tissue expansion treatment;
show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis (<2mm) with no improvement after suspending expansion for 2 weeks;
require further expansion to achieve the size for defect reconstruction.

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

1 site in 1 country.

China1 site

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Huangpu, 200011

Other trials in China

About this study

Official title: Quantitative Measurements of the Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation

This study is a prospective, exploratory investigation aimed at exploring the efficacy of 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, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.

Read the detailed description

The trial aims to include patients experiencing dermal exhaustion during the process of skin soft tissue expansion. We will extract SVF components from autologous adipose tissue and injected intradermally into the expanded skin. 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 Doppler 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
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 transplantationProcedure or surgery
Stromal vascular fraction was extracted from subcutaneous fat harvested from either the abdomen or the posterior inner thigh region. The SVF cell-pellet was washed and was adjusted to 2×10^6 cells/mL. 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. This procedure was repeated until adequate skin area was achieved for subsequent facial restoration surgery.

Study groups in NCT06439459
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. 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. This procedure was repeated until adequate skin area was achieved for subsequent facial restoration surgery. Receives: Procedure: Stromal vascular fraction transplantation

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: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation

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: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202325 Feb 2024

First posted3 Jun 2024
Study start15 Feb 2023
Primary completion21 Dec 2023
Study completion25 Feb 2024

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06439459
Sponsor's protocol ID: Shanghai9th-SDR-SVF-ZT
Other IDs: 22MC1940300, shslczdzk00901
Acronym: SDR-SVF
Status last verified: Jan 2023
First submitted: 27 May 2024
Last updated: 3 Jun 2024
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quantitative Measurements of the Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation
ClinicalTrials.gov ID: NCT06439459
Acronym / sponsor ID: SDR-SVF / Shanghai9th-SDR-SVF-ZT
Conditions: Skin Regeneration
Keywords: skin expansion, stromal vascular fraction
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
Study start: 15 Feb 2023 (actual)
Primary completion: 21 Dec 2023 (actual)
Study completion: 25 Feb 2024 (actual)
First posted: 3 Jun 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Stromal vascular fraction transplantation	Experimental	Procedure: 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. 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. This procedure was repeated until adequate skin area was achieved for subsequent facial restoration surgery.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

had undergone tissue expansion treatment;
show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis (<2mm) with no improvement after suspending expansion for 2 weeks;
require further expansion to achieve the size for defect reconstruction.

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 transplantationStromal vascular fraction was extracted from subcutaneous fat harvested from either the abdomen or the posterior inner thigh region. The SVF cell-pellet was washed and was adjusted to 2×10^6 cells/mL. 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. This procedure was repeated until adequate skin area was achieved for subsequent facial restoration surgery.	Procedure or surgery	Stromal vascular fraction transplantation

Primary outcome

Dermal thickness
Time frame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation
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: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation

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 3 Jun 2024.
Individual participant dataSharing planned: No. Any additional information regarding individual participants is available from the principle investigator of this study upon reasonable request.

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Recruiting
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Diabetic Foot Ulcers (DFUs), Diabetic Foot
Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stromal vascular fraction transplantation in people with Skin Regeneration, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site 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 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 3 Jun 2024. 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 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. 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?

Dermal thickness (time frame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation). 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 NCT06439459.

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 3 Jun 2024.