Autologous Human Stromal Vascular Fraction Injection in Post- Burn Hypertrophic Scar: A Double-Blinded Placebo-Controlled ClinicalTrial
- سال انتشار: 1397
- محل انتشار: سومین جشنواره ملی و کنگره بین المللی علوم و فناوری های سلول های بنیادی و پزشکی بازساختی
- کد COI اختصاصی: NSCMRMED03_115
- زبان مقاله: انگلیسی
- تعداد مشاهده: 656
نویسندگان
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology andTechnology, ACECR, Tehran, Iran
Shahid Motahari Hospital, Burn Research Center, Iran University of Medical Sciences, Tehran, Iran
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology andTechnology, ACECR, Tehran, Iran
Shahid Motahari Hospital, Burn Research Center, Iran University of Medical Sciences, Tehran, Iran
چکیده
Background and Aim: Post-burn hypertrophic scar (HTS) is a commoncomplication of burn injury which results from the prolongedinflammatory response, and leads to cosmetic, functional, andpsychological complications. Adipose-derived stromal vascular fraction(SVF) contains heterogenous cells with regenerative, anti-inflammatoryand anti-fibrotic properties.Methods: In this phase I randomized placebo-controlled clinical trial,we aimed to evaluate the safety and potential efficacy of intra-dermalinjection of autologous SVF in HTS. We enrolled 20 patients whohad HTS for more than 1 year with Vancouver scar scale (VSS) of ≥4.In each patient, two 6 cm2 scar sites were randomly received 2 mL ofSVF (1×106 cells/cm2) or normal saline. Patients were followed till 4months post-transplantation. Our primary endpoint was the number andseverity of adverse events. Our secondary endpoints were alterations inVSS score, skin thickness (dermal and epidermal layers) measured usinghigh resonance ultrasound, patient self-assessment of HTS improvementbased on visual analog scale (VAS), and level of expression of TGF-βassessed by immunohistochemical assay. This study has been registeredwith IRCT.ir (identifier: IRCT2012070710201N1).Results: Safety evaluations showed no major and serious adverseevents in treated patients. The mean VSS scores of the treatment andplacebo sites before the injection were 8.0±1.2 and 7.3 ±1.6 whichrespectively decreased to 6.4±1.4 and 6.7±1.7 at 4 months following celltransplantation. The mean VAS at 4 months after cell transplantation inSVF and control groups was respectively 3.2±2.2 and 0.7±1.8. The meanskin thickness in SVF group decreased from 2.9±0.7 mm to 2.7±0.6 mm,while in the control group was respectively 2.8 ±0.7 mm and 2.8±0.8mm, before and 4 months after the treatment. The expression level ofTGF-β3 increased in SVF group skin biopsy specimens compared toplacebo group, 4 months after cell injection.Conclusion: In this study, we demonstrated safety and tolerability ofautologous SVF intra-dermal injection in HTS. Besides, our study resultsindicated the potential efficacy of SVF injection in HTS probably via theanti-inflammatory and regenerative properties of SVF cells. However, thisneeds to be confirmed performing further investigations.کلیدواژه ها
Stromal cells Burns Cicatrix; Hypertrophic Regenerative medicineمقالات مرتبط جدید
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