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The Improving Effect of Autologous Stromal Vascular Fraction (SVF) in Adipose Tissue on Skin Grafting

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ClinicalTrials.gov Identifier: NCT02546882
Recruitment Status : Unknown
Verified September 2015 by Qing-Feng Li, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Collaborators:
West China Hospital
Guangzhou General Hospital of Guangzhou Military Command
Second Affiliated Hospital of Suzhou University
The First People's Hospital of Zhaoqing City
Wuhan Third Hospital
Information provided by (Responsible Party):
Qing-Feng Li, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Skin; Deformity, Due to Scar Biological: stromal vascular fraction Drug: saline Phase 1 Phase 2

Detailed Description:

Reconstruction of large scale skin defect is still a challenge for clinical surgeons. The application of skin grafting works as an important choice, however, the strong contracture and poor appearance limit its wide application in scar repair. The stromal vascular fraction (SVF) of adipose tissue is a group of heterogeneous cells including multipotential mesenchymal cells, preadipocytes, endothelial cells, fibroblasts, macrophages and smooth muscle cells. Previous researches have reported that SVF could secrete various angiogenic growth factors in vitro and enhance neovascularisation of ischaemic tissue in vivo. The Adipose-derived Stem cells in the SVF are multipotential stem cells which have the ability to regenerate, while differentiating to become adipose tissue and help to improve the texture of the grafted skin. Besides, SVF is easy to be harvested in large numbers with less donor injury and can be used directly after isolation without in vitro culture, which makes it a good alternative for regenerative medicine.This study is to observe the effect of autologous SVF on improving the texture and contracture of skin grafting.

Patients requiring skin graft of 2 symmetry parts of the body between the age of 3 and 70 years will be enrolled and randomized into two groups, named as the experimental group with SVF transplantation and the control group with no cell transplantation. Patients from the experimental group will have a fat aspiration on the surgery day. The adipose tissue in abdomen or thigh will be digested at 37 °C for 60 min with 0.2% collagenase IV. 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 SVF. The SVF will be resuspended in saline and transplanted between the grafted skin and the wound with 1 million cells for 1 cm2 area. Skin thickness, texture, contracture and colour will be observed to measure the effect of SVF on skin grafting post treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Autologous Stromal Vascular Fraction in Adipose Tissue Transplantation in Improving Skin Grafting
Study Start Date : February 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: stromal vascular fraction
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
1million stromal vascular fraction was resuspended in 1 ml saline and transplanted for 1 cm2 area.
Other Name: heterogeneous cell populations isolated from adipose tissue

Placebo Comparator: saline
1 ml saline without cells will be used as placebo.
Drug: saline
1 ml saline was injected for 1 cm2 area.
Other Name: normal saline




Primary Outcome Measures :
  1. Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment. [ Time Frame: 6 months post the treatment. ]
    Questionnaires scores satisfaction range from 0(not satisfied with the result) to 10(good result)


Secondary Outcome Measures :
  1. Occurence of major adverse events [ Time Frame: Up to approximately 18 months after study start ]
    Including skin graft ischaemia, necrosis, infection, and all other adverse events



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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546882


Contacts
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Contact: Qingfeng Li, MD, PhD 0086 21 63089567 dr.liqingfeng@yahoo.com
Contact: Hua Li, MD, PhD 0086 18621871963 laputanlee@hotmail.com

Locations
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China, Shanghai
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200011
Contact: Qingfeng Li, MD, PhD    0086 21 63089567    dr.liqingfeng@yahoo.com   
Contact: Hua Li, MD, PhD    0086 18621871963    lanputanlee@hotmail.com   
Principal Investigator: Qingfeng Li, MD,PhD         
Sub-Investigator: Hua Li, MD, PhD         
Sub-Investigator: Xiyuan Mao, MM         
Sub-Investigator: Chen Cheng, MD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
West China Hospital
Guangzhou General Hospital of Guangzhou Military Command
Second Affiliated Hospital of Suzhou University
The First People's Hospital of Zhaoqing City
Wuhan Third Hospital
Investigators
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Study Director: Qingfeng Li, MD, PhD Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

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Responsible Party: Qing-Feng Li, MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02546882     History of Changes
Other Study ID Numbers: 2012BAI11B03
2012BAI11B03 ( Other Grant/Funding Number: Scientific and Technical Supporting Programs )
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015

Keywords provided by Qing-Feng Li, Shanghai Jiao Tong University School of Medicine:
stromal vascular fraction
skin graft

Additional relevant MeSH terms:
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Skin Abnormalities
Congenital Abnormalities
Skin Diseases