Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration

NCT02336997 | Unknown Phase 1

• 1 other identifier: [2014]47
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluating whether autologous grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.

Conditions

Scar

Keywords

skin regeneration; mechanical stretch

Outcome Measures

Primary Outcomes (2)

• Occurence of Major Adverse Events

  Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events

  Up to approximately 24 months after study start

• To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks

  Record the inflation volume of each expander with the maintained inner pressure.

  baseline and 8 weeks post treatment

Secondary Outcomes (3)

• To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin

  baseline and 8 weeks post treatment

• To Measure the Texture of Expanded Flap with VISIA scanner

  4 weeks and 8 weeks post treatment

• To Measure Expanded Skin Thickness by Ultrasound Scanning

  baseline, 4 weeks and 8 weeks post treatment

Study Arms (3)

FAT-GRAFT

EXPERIMENTAL

Fat graft transplantation

Procedure: FAT-GRAFT

SVF-TRANSPLANTATION

EXPERIMENTAL

Transplantation of resuspended SVF

Procedure: SVF-TRANSPLANTATION

CONTROL

PLACEBO COMPARATOR

Same volume saline injection

Procedure: PLACEBO

Interventions

FAT-GRAFT PROCEDURE

Liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin at the density of 0.1 ml/cm2.

FAT-GRAFT

SVF-TRANSPLANTATION PROCEDURE

Liposuction will be performed. SVF will be separated from autologous fat graft by collagenase digestion. Patients will receive resuspended SVF transplantation subdermally to expanded skin at the density of 1\*10e6 cells/cm2.

SVF-TRANSPLANTATION

PLACEBO PROCEDURE

Saline will be injected into expanded skin.

CONTROL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age of 18 to 60 years;
• Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
• Implanted silicone expander of 80 to 600 ml in size;
• History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
• Persistent high level of expander internal pressure;
• Need for further skin expansion;

You may not qualify if:

• Not fit for soft tissue expansion treatment;
• Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; 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;
• History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
• History of allogenic bone marrow transplantation;
• Long history of smoking;
• Evidence of malignant diseases or unwillingness to participate.

Sponsors & Collaborators

• Qing-FengLi Li,MD: lead

Study Sites (2)

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Shanghai Ninth People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qing-Feng Li, M.D., Ph.D.

CONTACT

00862123271699

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: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 26, 2014
• First Posted: January 13, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CN (2)