Clinical trial NCT03189628: The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration
Official title: Study of Autologous Stromal Vascular Fraction From Adipose Tissue in Promoting Skin Regeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Skin
Aging
Keywords: stromal vascular fraction
skin regeneration
skin texture
anti-aging
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Measure the texture changes of the skin
timeFrame: Baseline and 12 months post the treatment
Secondary outcomes:
measure: Measure the colour changes of the skin
timeFrame: Baseline and 12 months post the treatment
measure: Occurence of major adverse events
timeFrame: Up to approximately 12 months after study start
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
name: Li Qingfeng, MD; PhD
role: STUDY_CHAIR
References: