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Role of Mesenchymal Stem Cells in Fat Grafting

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ClinicalTrials.gov Identifier: NCT02494752
Recruitment Status : Unknown
Verified July 2015 by Muhammad Mustehsan Bashir, King Edward Medical University.
Recruitment status was:  Not yet recruiting
First Posted : July 10, 2015
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
Muhammad Mustehsan Bashir, King Edward Medical University

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.

Condition or disease Intervention/treatment Phase
Romberg's Disease Craniofacial Microsomia Lipodystrophy Mixed Connective Tissue Disease Procedure: Fat graft enriched with ex vivo expanded stem cells Procedure: Fat graft not enriched with ex vivo expanded stem cells Not Applicable

Detailed Description:

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Potential of Mesenchymal Stem Cell Enriched Adipose Tissue Grafting for Contour Deformities of Face
Study Start Date : August 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: Stem cell enriched
Fat graft will be enriched with ex vivo expanded stem cells
Procedure: Fat graft enriched with ex vivo expanded stem cells
Fat graft will be enriched with ex vivo expanded stem cells

Active Comparator: Non stem cell enriched
Fat graft will not be enriched with ex vivo expanded stem cells
Procedure: Fat graft not enriched with ex vivo expanded stem cells
Fat graft will not be enriched with ex vivo expanded stem cells




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02494752


Contacts
Contact: Muhammad M Bashir, F.C.P.S 923336517745 mmbashir1@gmail.com
Contact: Mahmood S Chaudhry, PhD 923214110894 ms20031@yahoo.com

Sponsors and Collaborators
King Edward Medical University

Publications:

Responsible Party: Muhammad Mustehsan Bashir, Associate professor of Plastic Surgery, King Edward Medical University
ClinicalTrials.gov Identifier: NCT02494752     History of Changes
Other Study ID Numbers: 229/RC/KEMU
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: July 2015

Keywords provided by Muhammad Mustehsan Bashir, King Edward Medical University:
Contour deformities of face
autologous fat grafting
Post traumatic facial contour defects

Additional relevant MeSH terms:
Craniofacial Dysostosis
Lipodystrophy
Connective Tissue Diseases
Mixed Connective Tissue Disease
Goldenhar Syndrome
Facial Hemiatrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Mandibulofacial Dysostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases