The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration

Aging Clinical Trial

Official title:

Study of Autologous Stromal Vascular Fraction From Adipose Tissue in Promoting Skin Regeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03189628
• Other study ID #: 2016-261-T196
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 22, 2017
• Last updated: June 14, 2017
• Start date: March 13, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: June 2017
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Li Qingfeng, MD; PhD
• Phone: 0086 21 63089567
• Email: dr.liqingfeng[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 13, 2018
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Aging
• Skin

Intervention

Biological:
• stromal vascular fraction
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.

Drug:
• Saline
1 ml saline was injected for 3 area including the forehead?palpebra inferior and crow's-feet.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the texture changes of the skin	Using Cutometer® dual MPA 580 in 12 months post the treatment.	Baseline and 12 months post the treatment
Secondary	Measure the colour changes of the skin	Using Canfield Scientific VISIA in 12 months post the treatment.	Baseline and 12 months post the treatment
Secondary	Occurence of major adverse events	Including skin necrosis, infection, erythra and all other adverse events	Up to approximately 12 months after study start