NCT03189628

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

May 22, 2017

Last Update Submit

June 14, 2017

Conditions

SkinAging

Keywords

stromal vascular fractionskin regenerationskin textureanti-aging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Measure the colour changes of the skin

    Baseline and 12 months post the treatment

  • Occurence of major adverse events

    Up to approximately 12 months after study start

Study Arms (2)

stromal vascular fraction

EXPERIMENTAL

Transplantation of resuspended SVF

Biological: stromal vascular fraction

saline

PLACEBO COMPARATOR

1 ml saline without cells will be used as placebo.

Drug: Saline

Interventions

stromal vascular fractionBIOLOGICAL

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.

Also known as: heterogeneous cell populations isolated from adipose tissue
stromal vascular fraction
SalineDRUG

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

Also known as: normal saline
saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38987318DERIVED

MeSH Terms

Interventions

Sodium ChlorideSaline Solution

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Li Qingfeng, MD; PhD

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

    STUDY CHAIR

Central Study Contacts

Li Qingfeng, MD; PhD

CONTACT

0086 21 63089567dr.liqingfeng@yahoo.com

He Jizhou, MD

CONTACT

0086 21 15800806993michael_he@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor, Head of Departement of Plastic and Reconstructive Surgery, Shanghai 9th People's Hospital

Study Record Dates

First Submitted

May 22, 2017

First Posted

June 16, 2017

Study Start

March 13, 2017

Primary Completion

August 25, 2017

Study Completion

March 13, 2018

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

CN(1)