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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stromal vascular fraction | Experimental | Transplantation of resuspended SVF |
|
| saline | Placebo Comparator | 1 ml saline without cells will be used as placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stromal vascular fraction | Biological | 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 foreheadăpalpebra inferior and crow's-feet. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the texture changes of the skin | Using CutometerÂŽ dual MPA 580 in 12 months post the treatment. | Baseline and 12 months post the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the colour changes of the skin | Using Canfield Scientific VISIA in 12 months post the treatment. | Baseline and 12 months post the treatment |
| Occurence of major adverse events | Including skin necrosis, infection, erythra and all other adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Qingfeng, MD; PhD | Contact | 0086 21 63089567 | dr.liqingfeng@yahoo.com | |
| He Jizhou, MD | Contact | 0086 21 15800806993 | michael_he@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Qingfeng, MD; PhD | Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38987318 | Derived | 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. |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| Saline | Drug | 1 ml saline was injected for 3 area including the foreheadăpalpebra inferior and crow's-feet. |
|
|
| Up to approximately 12 months after study start |
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |