The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration

NCT ID: NCT03189628

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2018-03-13

Brief Summary

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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.

Detailed Description

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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

Conditions

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Skin Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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stromal vascular fraction

Transplantation of resuspended SVF

Group Type EXPERIMENTAL

stromal vascular fraction

Intervention Type 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 forehead、palpebra inferior and crow's-feet.

saline

1 ml saline without cells will be used as placebo.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

1 ml saline was injected for 3 area including the forehead、palpebra inferior and crow's-feet.

Interventions

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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.

Intervention Type BIOLOGICAL

Saline

1 ml saline was injected for 3 area including the forehead、palpebra inferior and crow's-feet.

Intervention Type DRUG

Other Intervention Names

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heterogeneous cell populations isolated from adipose tissue normal saline

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Qing-FengLi Li,MD

MD, PhD, Professor, Head of Departement of Plastic and Reconstructive Surgery, Shanghai 9th People's Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Qingfeng, MD; PhD

Role: STUDY_CHAIR

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Qingfeng, MD; PhD

Role: CONTACT

0086 21 63089567

He Jizhou, MD

Role: CONTACT

0086 21 15800806993

Facility Contacts

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Li Qing Feng, MD; PhD

Role: primary

0086 21 63089567

He Ji Zhou, MD

Role: backup

0086 21 15800806993

References

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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.

Reference Type DERIVED
PMID: 38987318 (View on PubMed)

Other Identifiers

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2016-261-T196

Identifier Type: -

Identifier Source: org_study_id

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