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临床试验/NCT02494752
NCT02494752Unknown不适用

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

King Edward Medical University0 个研究点目标入组 30 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Change from baseline in thickness of subcutaneous tissue

研究概览

简要总结

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.

详细描述

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-transplantation in plastic surgery has evolved from a controversial technique designed for simple volume augmentation to the foundation for the innovative and burgeoning field of regenerative medicine. This is based on the fact that adipose tissue contains adipocytes and the stromal vascular fraction (SVF) consisting of multiple cell types such as circulating blood cells, fibroblasts, pericytes, endothelial cells, and mesenchymal stem cells (MSCs). Adipocytes account for 20 percent or fewer of the total number of cells in adipose tissue4whereasthere are only 3% MSCs in SVF of adipose tissue.5 Although this percentage is relatively low, this cell type is the main contributor in overall healing process. MSCs derived from adipose tissue (AT-MSCs) have high proliferative potential and ability to differentiate into mesenchymal (adipose, bone, cartilage) and non-mesenchymal (neuron like cells) lineages.6,7,8 AT-MSCs have been shown to enhance angiogenesis, decrease apoptosis and modify the local inflammatory response owing to their immunosuppressive and immunomodulatory properties.9 Therefore, the current study is designed to evaluate the effect of fat grafting and AT-MSCs together on contour deformities of face. By combining traditional fat graft with AT-MSCs, tissue viability and therefore the consistency of graft survival may be improved. In the current model investigators propose that transferred fat may act as a natural scaffold and temporary filler to restore the volume immediately while AT-MSCs will start participating in multiple parameters of tissue regeneration. This model supports the "host replacement theory" that has been put forward to describe how fat grafts survive after they are transplanted.10 Due to problems associated with fat grafting alone, it is desirable to solve such issues by using innovating techniques. In the current study investigators propose the novel idea of enrichment of conventional fat graft with ex-vivo expanded AT-MSCs to enhance the viability of the grafted fat and the reliability of the final outcome of surgery. Recent animal studies have suggested that AT-MSCs that have been expanded before administration could help preserve grafted fat and improve outcomes.11 Thus rationale of current study is to compare the outcome of conventional fat grafting with stem cell enriched fat grafting for contour deformities of face. If enrichment of fat graft with AT-MSCs can decrease its absorption rate, this innovative strategy can make fat transfer a reliable option for soft tissue augmentation. This can definitely improve final clinical outcome at lesser cost and reduced donor site morbidity

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with congenital and acquired contour deformities of face requiring soft tissue augmentation .
  • Must be 16-60 years of age
  • Must be American Society of Anesthesiology (ASA) class 1 and 2

排除标准

  • Patients with contour deformities in which skin is adherent to facial skeleton
  • Contour deformities underlying skin grafted areas of face
  • Abdominal skin pinch thickness less than 3 inch

结局指标

主要结局

Change from baseline in thickness of subcutaneous tissue

时间窗: 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.

次要结局

  • Change from base line in post operative appearance(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Mustehsan Bashir

Associate professor of Plastic Surgery

King Edward Medical University

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