دورية أكاديمية
Umbilical Cord Blood-Derived Fluid Allograft Product in Foot and Ankle Surgery: Early Results from a Prospective Registry
العنوان: | Umbilical Cord Blood-Derived Fluid Allograft Product in Foot and Ankle Surgery: Early Results from a Prospective Registry |
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المؤلفون: | Paul Cooper MD, Billy Petzold, Steven Czop BS, Mukta Sane PhD, Huiyuan Tang PhD, Soumyajit Banerjee Mustafi PhD, Christopher Jones |
المصدر: | Foot & Ankle Orthopaedics, Vol 4 (2019) |
بيانات النشر: | SAGE Publishing, 2019. |
سنة النشر: | 2019 |
المجموعة: | LCC:Orthopedic surgery |
مصطلحات موضوعية: | Orthopedic surgery, RD701-811 |
الوصف: | Category: Ankle, Ankle Arthritis, Basic Sciences/Biologics, Hindfoot, Surgery Introduction/Purpose: Foot and ankle surgery with bone grafting relieves pain and improves function in patients with hind/midfoot conditions. Umbilical cord blood (UCB) derived allografts have gained recent prominence for their potential in tissue regeneration. UCB is enriched with cytokines which regulate autocrine and paracrine signaling. BioBurst Fluid (BBF) is a UCB derived cellular allograft carefully processed by the patent pending Progenokine™ technique to preserve the unique molecular heterogeneity of UCB. Clinical study is being conducted to determine the safety and efficacy of BBF administered in patients undergoing foot and ankle surgery (NCT03077256). Here we report our initial data from this ongoing study. In vitro biochemical characterization of BBF further established the osteogenic potential of this allograft and provided mechanistic link to its clinical efficiency. Methods: 57 patients undergoing surgery with concomitant BBF administration were enrolled in an IRB-approved study, the selection criteria being not to exclude anyone. Data obtained from 21 of the 57 enrolled patients completing their 6-month post- op is reported. The prospective registry recorded patient demographics, comorbidities, symptoms, fusion status, pain, pain medication use, and neurological status up to 6 months post-op. Surgical, immediate post-op, and follow-up complications were also recorded. Fusion was assessed at 3 and 6 months via anteroposterior and lateral x-rays. Pain and function were assessed with Visual Analogue Scale/VAS and modified Odom’s criteria. Neurological status was recorded as improved, maintained, or worse. Narcotic and NSAID use were rated as increased/same or decreased/discontinued. For in vitro characterization of BBF, standard cell-biology methods were employed using MSC as model system. Cytokine concentration in 30 random BBF lots was determined by Luminex multiplex assay. All data are analyzed using appropriate statistical tools. Results: No complications from administration of BBF were seen intra-operatively and during follow-up. Successful fusion (>50% incorporation) was achieved in 20/21 patients (95%) with 8 patients having fusion by 3 months. One non-union occurred in an HIV positive patient. VAS pain score improved clinically from pre-op at 3 months (-3.3, p |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 2473-0114 24730114 |
العلاقة: | https://doaj.org/toc/2473-0114Test |
DOI: | 10.1177/2473011419S00151 |
الوصول الحر: | https://doaj.org/article/9d206d8c05e0446ba28109399460a1c5Test |
رقم الانضمام: | edsdoj.9d206d8c05e0446ba28109399460a1c5 |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 24730114 |
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DOI: | 10.1177/2473011419S00151 |