Lipodystrophy Clinical Trial
Official title:
Potential of Mesenchymal Stem Cell Enriched Adipose Tissue Grafting for Contour Deformities of Face
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 60 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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King Edward Medical University |
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. — View Citation
Bollero D, Pozza S, Gangemi EN, De Marchi A, Ganem J, A M el K, Faletti C, Stella M. Contrast-enhanced ultrasonography evaluation after autologous fat grafting in scar revision. G Chir. 2014 Nov-Dec;35(11-12):266-73. — View Citation
Brown SA, Levi B, Lequeux C, Wong VW, Mojallal A, Longaker MT. Basic science review on adipose tissue for clinicians. Plast Reconstr Surg. 2010 Dec;126(6):1936-46. doi: 10.1097/PRS.0b013e3181f44790. Review. Erratum in: Plast Reconstr Surg. 2011 Feb;127(2):1025. Lequex, Charlotte [corrected to Lequeux, Charlotte]. — View 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. — View Citation
Cheong YW, Lo LJ. Facial asymmetry: etiology, evaluation, and management. Chang Gung Med J. 2011 Jul-Aug;34(4):341-51. Review. — View 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. — View Citation
Choudhery MS, Badowski M, Muise A, Pierce J, Harris DT. Cryopreservation of whole adipose tissue for future use in regenerative medicine. J Surg Res. 2014 Mar;187(1):24-35. doi: 10.1016/j.jss.2013.09.027. Epub 2013 Oct 8. — View 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. — View Citation
Eto H, Kato H, Suga H, Aoi N, Doi K, Kuno S, Yoshimura K. The fate of adipocytes after nonvascularized fat grafting: evidence of early death and replacement of adipocytes. Plast Reconstr Surg. 2012 May;129(5):1081-92. doi: 10.1097/PRS.0b013e31824a2b19. — View 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):249-58. doi: 10.1097/PRS.0b013e318254b4d3. Review. — View Citation
Gir P, Oni G, Brown SA, Mojallal A, Rohrich RJ. Human adipose stem cells: current clinical applications. Plast Reconstr Surg. 2012 Jun;129(6):1277-90. doi: 10.1097/PRS.0b013e31824ecae6. Review. — View Citation
Kølle SF, Fischer-Nielsen A, Mathiasen AB, Elberg JJ, Oliveri RS, Glovinski PV, Kastrup J, Kirchhoff M, Rasmussen BS, Talman ML, Thomsen C, Dickmeiss E, Drzewiecki KT. Enrichment of autologous fat grafts with ex-vivo expanded adipose tissue-derived stem cells for graft survival: a randomised placebo-controlled trial. Lancet. 2013 Sep 28;382(9898):1113-20. doi: 10.1016/S0140-6736(13)61410-5. — View Citation
Tiryaki T, Findikli N, Tiryaki D. Staged stem cell-enriched tissue (SET) injections for soft tissue augmentation in hostile recipient areas: a preliminary report. Aesthetic Plast Surg. 2011 Dec;35(6):965-71. doi: 10.1007/s00266-011-9716-x. Epub 2011 Apr 13. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 weeks | No |
Secondary | 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. | 24 weeks | No |
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