SkinPhase 1/2NCT03189628
The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration
A Phase 1/2 study testing stromal vascular fraction and Saline in people with Skin and Aging, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- stromal vascular fraction and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2017to 13 Mar 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 to 65.
- No other facial plastic surgery or cosmetic surgery was performed during the study period (frontal, temporal, and lower eyelid).
- Intends to undergo facial anti-aging treatment with SVF
Who cannot join
- Not fit for stem cells graft treatment.
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for SVF treatment; 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).
- Used external medication on the targeting area within 4 weeks.
- Skin invasive treatment including laser on the targeting area within 6 months.
Show all 10Show fewer
- Hyaluronic acid injection on the targeting area within 12 months.
- Botulinum toxin injection on the targeting area within 6 months.
- History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis.
- Evidence of malignant diseases or unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Li Qing Feng, MD; PhD, 0086 21 63089567, dr.liqingfeng@yahoo.com
He Ji Zhou, MD, 0086 21 15800806993, michael_he@126.com
About this study
Official title: Study of Autologous Stromal Vascular Fraction From Adipose Tissue in Promoting Skin Regeneration
The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.
Read the detailed description
This is a randomized controlled single blind clinal trial that designed to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.
The clinical trial will concentrate on the therapeutic effect of SVF after facial injection. After 1, 4, 8, 12, 24 and 48 weeks of treatment, a comprehensive examination of the facial skin was performed to assess the effect of the SVF. Skin texture, thickness and colour will be observed to evaluate the effect of SVF on skin regeneration
- Being tested
- stromal vascular fraction, Saline
- Keywords
- stromal vascular fraction, skin regeneration, skin texture, anti-aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stromal vascular fractionBiological
Also called heterogeneous cell populations isolated from adipose tissue
The adipose tissue(no less than 40ml) in abdomen will be harvested and digested at 37 °C for (45-60) min with (0.125-1.5)mg/ml collagenase . After filtration and centrifugation at the speed of (700-1500)g, mature adipocytes are separated from the cell pellet. The pellet then is treated with saline twice to remove cell fragment and rudimental collagenase . The harvested pellet is stromal vascular fraction (SVF) The SVF was resuspended in 1 ml saline and transplanted for 3 area including the forehead、palpebra inferior and crow's-feet.
SalineDrug
Also called normal saline
1 ml saline was injected for 3 area including the forehead、palpebra inferior and crow's-feet.
| Study group | Role | What they receive |
|---|---|---|
| stromal vascular fraction | Experimental | Transplantation of resuspended SVF Receives: Biological: stromal vascular fraction |
| saline | Placebo comparator | 1 ml saline without cells will be used as placebo. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the texture changes of the skin
Using Cutometer® dual MPA 580 in 12 months post the treatment.
Measured: Baseline and 12 months post the treatment
Secondary outcomes (2)
Measure the colour changes of the skin
Using Canfield Scientific VISIA in 12 months post the treatment.
Measured: Baseline and 12 months post the treatment
Occurence of major adverse events
Including skin necrosis, infection, erythra and all other adverse events
Measured: Up to approximately 12 months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start13 Mar 2017
- Primary completion25 Aug 2017 (estimated)
- Study completion13 Mar 2018 (estimated)
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 SkinStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Li Qingfeng, MD; PhD, Study chair, Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189628
- Sponsor's protocol ID
- 2016-261-T196
- Status last verified
- Jun 2017
- First submitted
- 22 May 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qin J, Cheng C, Huang RL, He J, Zhou S, Tan PC, Zhang T, Fang B, Li Q, Xie Y. Isolation of the Stromal Vascular Fraction Using a New Protocol with All Clinical-Grade Drugs: From Basic Study to Clinical Application. Aesthetic Plast Surg. 2024 Nov;48(22):4702-4711. doi: 10.1007/s00266-024-04221-9. Epub 2024 Jul 10.
PubMed 38987318
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Autologous Stromal Vascular Fraction From Adipose Tissue in Promoting Skin Regeneration
- ClinicalTrials.gov ID
- NCT03189628
- Acronym / sponsor ID
- 2016-261-T196
- Keywords
- stromal vascular fraction, skin regeneration, skin texture, anti-aging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 25 Aug 2017 (estimated)
- Study completion
- 13 Mar 2018 (estimated)
- First posted
- 16 Jun 2017 (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.
The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.
Detailed description
This is a randomized controlled single blind clinal trial that designed to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.
The clinical trial will concentrate on the therapeutic effect of SVF after facial injection. After 1, 4, 8, 12, 24 and 48 weeks of treatment, a comprehensive examination of the facial skin was performed to assess the effect of the SVF. Skin texture, thickness and colour will be observed to evaluate the effect of SVF on skin regeneration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stromal vascular fraction | Experimental | Biological: stromal vascular fractionTransplantation of resuspended SVF |
| saline | Placebo comparator | Drug: Saline1 ml saline without cells will be used as placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 to 65.
- No other facial plastic surgery or cosmetic surgery was performed during the study period (frontal, temporal, and lower eyelid).
- Intends to undergo facial anti-aging treatment with SVF
Key exclusion criteria (10 listed)
- Not fit for stem cells graft treatment.
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for SVF treatment; 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).
- Used external medication on the targeting area within 4 weeks.
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 fractionAlso: heterogeneous cell populations isolated from adipose tissueThe adipose tissue(no less than 40ml) in abdomen will be harvested and digested at 37 °C for (45-60) min with (0.125-1.5)mg/ml collagenase . After filtration and centrifugation at the speed of (700-1500)g, mature adipocytes are separated from the cell pellet. The pellet then is treated with saline twice to remove cell fragment and rudimental collagenase . The harvested pellet is stromal vascular fraction (SVF) The SVF was resuspended in 1 ml saline and transplanted for 3 area including the forehead、palpebra inferior and crow's-feet. | Biological | stromal vascular fraction |
| SalineAlso: normal saline1 ml saline was injected for 3 area including the forehead、palpebra inferior and crow's-feet. | Drug | saline |
Primary outcome
Measure the texture changes of the skin
Time frame: Baseline and 12 months post the treatment
Using Cutometer® dual MPA 580 in 12 months post the treatment.
2 secondary outcomes
Measure the colour changes of the skin
Time frame: Baseline and 12 months post the treatment
Occurence of major adverse events
Time frame: Up to approximately 12 months after study start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Derived from this study: PubMed 38987318Qin J, Cheng C, Huang RL, He J, Zhou S, Tan PC, Zhang T, Fang B, Li Q, Xie Y. Isolation of the Stromal Vascular Fraction Using a New Protocol with All Clinical-Grade Drugs: From Basic Study to Clinical Application. Aesthetic Plast Surg. 2024 Nov;48(22):4702-4711. doi: 10.1007/s00266-024-04221-9. Epub 2024 Jul 10.
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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.
Li Qingfeng, MD; PhD study chair
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
1 site 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 stromal vascular fraction and Saline in people with Skin and Aging, run by Shanghai Jiao Tong University School of Medicine 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 10 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 16 Jun 2017. 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. 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 Li Qingfeng, MD; PhD (0086 21 63089567, dr.liqingfeng@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the texture changes of the skin (time frame: Baseline and 12 months post the treatment). 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 NCT03189628, 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 16 Jun 2017.