Clinical Trial: Role of Mesenchymal Stem Cells in Fat Grafting

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Potential of Mesenchymal Stem Cell Enriched Adipose Tissue Grafting for Contour Deformities of Face

Brief Summary: Contour deformity of face causes both functional as well as aesthetic problems for the patient. Fat being an autologous tissue source is considered as an ideal soft-tissue filler because it is abundant, readily available, inexpensive, host compatible, and can be harvested easily and repeatedly. However absorption of grafted fat is a major problem resulting in lack of consistency of final clinical outcome. Adipose tissue derived mesenchymal stem cells have the potential to enhance the viability of the grafted fat and the reliability of the final outcome of surgery. In the current study potential of mesenchymal stem cells will be studied by comparing two groups of patients requiring fat grafting for contour deformities of face. Control group will have fat graft with out enrichment with stem cells whereas experimental group will have their fat graft enriched with mesenchymal stem cells. Comparison will be made regarding viability of grafted fat in two groups.

Detailed Summary:

Contour deformities of the face requiring soft tissue augmentation often result from conditions such as congenital disorders, acquired diseases, and traumatic and developmental deformities. Significant contour deformity of face causes both functional as well as aesthetic problems for the patient. Conventionally, these problems are treated by allogenic fillers, major flap surgery and fat grafting.1 However; different problems are associated with above mentioned treatment options. For example, allogenic fillers are foreign material that poses not only allergic reactions but also rapid absorption at the site of application. Similarly, flap surgery, in the form of pedicled and free flaps, produces considerable donor site morbidity. In addition, fine- tuning is impossible with flap, and tissue transferred in the form of flap may act as blob.

Autologous fat grafting has gained pervasive acceptance for the management of contour deformities of the face. Fat being an autologous tissue source is considered as an ideal soft-tissue filler because it is abundant, readily available, inexpensive, host compatible, and can be harvested easily and repeatedly.2 Although the practice of fat grafting is not new and it is a safe and natural method of soft-tissue augmentation, the viability and reliability of transplanted fat grafts remains poorly studied. One major concern is the lack of consistency of final clinical outcome, which often requires multiple fat grafting procedures making it expensive. Rate of fat absorption may reach up to 40% to 80%.However, previously published data have failed to produce a cohesive algorithm of the required components for successful, consistent and durable fat transplantation.3 In order to overcome problems associated with fat grafting, other innovative techniques are required.

The role of fat auto-transplanta
Sponsor: King Edward Medical University

Current Primary Outcome: Change from baseline in thickness of subcutaneous tissue [ Time Frame: 24 weeks ]

Objective assessment will be made by doing baseline B mode colour Doppler ultrasonography of the treated area.The operator blinded to the group allocation will measure the thickness of the subcutaneous tissue (in millimeters) in the treated area during the baseline examination with ultrasound B-mode. In order to have a reproducible measurement in subsequent examinations, the operator will look for and note down precise anatomical landmarks or, in case of large areas, will mark the points with an indelible marker, saving a digital image for future reference. Patients will again under go ultrasonography of the treated area at 24 weeks post treatment. During this repeat ultra sonography same operator will again measure the subcutaneous thickness of the treated in millimeters. The difference in two measurements will be noted down as residual volume. Means of residual volumes in two groups will be compared.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change from base line in post operative appearance [ Time Frame: 24 weeks ]

Subjective assessment will be done by taking photographs preoperatively and 24 weeks post treatment months under standard conditions of light, distance, views and camera make. Two plastic surgeons blinded to group allocation will rate post operative appearance as satisfactory/unsatisfactory by comparing pre and post operative photographs.


Original Secondary Outcome: Same as current

Information By: King Edward Medical University

Dates:
Date Received: July 4, 2015
Date Started: August 2015
Date Completion: February 2016
Last Updated: July 9, 2015
Last Verified: July 2015