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Role of Mesenchymal Stem Cells in Fat Grafting

Primary Purpose

Romberg's Disease, Craniofacial Microsomia, Lipodystrophy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fat graft enriched with ex vivo expanded stem cells
Fat graft not enriched with ex vivo expanded stem cells
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Romberg's Disease focused on measuring Contour deformities of face, autologous fat grafting, Post traumatic facial contour defects

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Stem cell enriched

    Non stem cell enriched

    Arm Description

    Fat graft will be enriched with ex vivo expanded stem cells

    Fat graft will not be enriched with ex vivo expanded stem cells

    Outcomes

    Primary Outcome Measures

    Change from baseline in thickness of subcutaneous tissue
    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

    Change from base line in post operative appearance
    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.

    Full Information

    First Posted
    July 4, 2015
    Last Updated
    July 9, 2015
    Sponsor
    King Edward Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02494752
    Brief Title
    Role of Mesenchymal Stem Cells in Fat Grafting
    Official Title
    Potential of Mesenchymal Stem Cell Enriched Adipose Tissue Grafting for Contour Deformities of Face
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    February 2016 (Anticipated)
    Study Completion Date
    February 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Edward Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Romberg's Disease, Craniofacial Microsomia, Lipodystrophy, Mixed Connective Tissue Disease
    Keywords
    Contour deformities of face, autologous fat grafting, Post traumatic facial contour defects

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stem cell enriched
    Arm Type
    Experimental
    Arm Description
    Fat graft will be enriched with ex vivo expanded stem cells
    Arm Title
    Non stem cell enriched
    Arm Type
    Active Comparator
    Arm Description
    Fat graft will not be enriched with ex vivo expanded stem cells
    Intervention Type
    Procedure
    Intervention Name(s)
    Fat graft enriched with ex vivo expanded stem cells
    Intervention Description
    Fat graft will be enriched with ex vivo expanded stem cells
    Intervention Type
    Procedure
    Intervention Name(s)
    Fat graft not enriched with ex vivo expanded stem cells
    Intervention Description
    Fat graft will not be enriched with ex vivo expanded stem cells
    Primary Outcome Measure Information:
    Title
    Change from baseline in thickness of subcutaneous tissue
    Description
    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.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Change from base line in post operative appearance
    Description
    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.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muhammad M Bashir, F.C.P.S
    Phone
    923336517745
    Email
    mmbashir1@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmood S Chaudhry, PhD
    Phone
    923214110894
    Email
    ms20031@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21880188
    Citation
    Cheong YW, Lo LJ. Facial asymmetry: etiology, evaluation, and management. Chang Gung Med J. 2011 Jul-Aug;34(4):341-51.
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    18090347
    Citation
    Bucky LP, Kanchwala SK. The role of autologous fat and alternative fillers in the aging face. Plast Reconstr Surg. 2007 Nov;120(6 Suppl):89S-97S. doi: 10.1097/01.prs.0000248866.57638.40.
    Results Reference
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    PubMed Identifier
    22743888
    Citation
    Gir P, Brown SA, Oni G, Kashefi N, Mojallal A, Rohrich RJ. Fat grafting: evidence-based review on autologous fat harvesting, processing, reinjection, and storage. Plast Reconstr Surg. 2012 Jul;130(1):249-258. doi: 10.1097/PRS.0b013e318254b4d3.
    Results Reference
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    PubMed Identifier
    21124133
    Citation
    Brown SA, Levi B, Lequex C, Wong VW, Mojallal A, Longaker MT. Basic science review on adipose tissue for clinicians. Plast Reconstr Surg. 2010 Dec;126(6):1936-1946. doi: 10.1097/PRS.0b013e3181f44790. Erratum In: Plast Reconstr Surg. 2011 Feb;127(2):1025. Lequex, Charlotte [corrected to Lequeux, Charlotte].
    Results Reference
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    PubMed Identifier
    22577397
    Citation
    Baer PC, Geiger H. Adipose-derived mesenchymal stromal/stem cells: tissue localization, characterization, and heterogeneity. Stem Cells Int. 2012;2012:812693. doi: 10.1155/2012/812693. Epub 2012 Apr 12.
    Results Reference
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    PubMed Identifier
    24397850
    Citation
    Choudhery MS, Badowski M, Muise A, Pierce J, Harris DT. Donor age negatively impacts adipose tissue-derived mesenchymal stem cell expansion and differentiation. J Transl Med. 2014 Jan 7;12:8. doi: 10.1186/1479-5876-12-8.
    Results Reference
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    PubMed Identifier
    23318344
    Citation
    Choudhery MS, Badowski M, Muise A, Harris DT. Comparison of human mesenchymal stem cells derived from adipose and cord tissue. Cytotherapy. 2013 Mar;15(3):330-43. doi: 10.1016/j.jcyt.2012.11.010. Epub 2013 Jan 11.
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    PubMed Identifier
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