NCT02546882

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 the texture and contracture of skin grafting.

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
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2015

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

First Submitted

Initial submission to the registry

January 23, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

January 23, 2014

Last Update Submit

September 9, 2015

Conditions

Skin; Deformity, Due to Scar

Keywords

stromal vascular fractionskin graft

Outcome Measures

Primary Outcomes (1)

  • Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment.

    Questionnaires scores satisfaction range from 0(not satisfied with the result) to 10(good result)

    6 months post the treatment.

Secondary Outcomes (1)

  • Occurence of major adverse events

    Up to approximately 18 months after study start

Study Arms (2)

stromal vascular fraction

EXPERIMENTAL

The adipose tissue in abdomen or thigh will be harvested and digested at 37 °C for 60 min with 0.2% collagenase I/Ⅲ. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is stromal vascular fraction (SVF).

Biological: stromal vascular fraction

saline

PLACEBO COMPARATOR

1 ml saline without cells will be used as placebo.

Drug: saline

Interventions

stromal vascular fractionBIOLOGICAL

1million stromal vascular fraction was resuspended in 1 ml saline and transplanted for 1 cm2 area.

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

1 ml saline was injected for 1 cm2 area.

Also known as: normal saline
saline

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • With symmetrical scar or soft tissue deficiencies requiring skin graft therapy.
  • Age of 3 to 70.
  • Have no underlying disease except skin scar deformity.
  • Have enough healthy donor site skin for both sides of receiving area.

You may not qualify if:

  • Not fit for skin graft treatment;
  • Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for skin grafting; 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);
  • BMI \>30;
  • Alcohol abuse
  • 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

Conditions

Congenital Abnormalities

Interventions

Sodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Qingfeng Li, MD, PhD

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    STUDY DIRECTOR

Central Study Contacts

Qingfeng Li, MD, PhD

CONTACT

0086 21 63089567dr.liqingfeng@yahoo.com

Hua Li, MD, PhD

CONTACT

0086 18621871963laputanlee@hotmail.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 the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital

Study Record Dates

First Submitted

January 23, 2014

First Posted

September 11, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

September 11, 2015

Record last verified: 2015-09

Locations

CN(1)