背景:双相磷酸钙(BCP)可以作为牙槽突裂重建中的骨来源自体骨的现成替代品。为了增加骨传导性BCP的骨诱导性,以实现与自体骨相似的再生能力,局部收获的颊脂肪垫将被机械分馏以产生微碎片化的脂肪(MFAT),由于高的周细胞和间充质干细胞含量以及保留的血管周围小生境,已被证明具有很高的再生能力。
目的:我们的主要目标是评估BCP-MFAT联合用药的可行性和安全性。次要目标将是功效,这将使用X线成像和组织学和组织形态学评估的活检进行评估术后6个月,伴随着牙种植体的放置。
方法:本前瞻性研究将包括8例牙槽沟裂(≥15岁)患者,非盲化,首次在人类临床研究。将在术中从患者自身的颊脂肪垫制备MFAT。将定期进行血液检查和体检,和任何不良事件(AE)或严重的EA(SAE)将被精心记录。放射摄影成像将在手术前和在用BCP-MFAT组合重建肺泡裂隙后定期进行。在甲基丙烯酸甲酯包埋和切片后,将通过组织学和组织形态分析评估6个月后使用用于准备植入部位的环钻获得的活检。
结果:主要结果参数是随访6个月后的安全性,根据射线照相成像,使用可能发生的SAE密切监测,验血,和体检。为了疗效,放射成像将用于使用Bergland量表对骨构造进行临床分级。此外,骨参数,如骨体积,类骨质体积,移植物体积,和破骨细胞的数量将进行组织形态定量。2019年11月开始招募,目前试验处于后续阶段。该协议的当前版本是1.0,日期为2019年9月15日。
结论:在这项首次人体研究中,不仅安全性,而且组织学和影像学评估的BCP-MFAT组合的再生潜力也将在肺泡裂模型中进行评估.当SAE发生时,将得出结论,BCP-MFAT组合在当前设置中还不安全。关于AE,如果它们的发生频率不高于标准治疗(自体骨)或可以通过非侵入性常规方法解决的患者(例如,用镇痛药或抗生素),BCP-MFAT组合将被认为是安全的。在所有其他情况下,BCP-MFAT组合尚未被认为是安全的。
背景:印度尼西亚临床试验注册INA-EW74C1N;https://tinyurl.com/28tnrr64。
■DERR1-10.2196/42371。
BACKGROUND: Biphasic calcium phosphates (BCP) may serve as off-the-shelf alternatives for iliac crest-derived autologous bone in alveolar cleft reconstructions. To add osteoinductivity to the osteoconductive BCPs to achieve similar regenerative capacity as autologous bone, a locally harvested buccal fat pad will be mechanically fractionated to generate microfragmented fat (MFAT), which has been shown to have high regenerative capacity due to high pericyte and mesenchymal stem cell content and a preserved perivascular niche.
OBJECTIVE: Our primary objectives will be to assess the feasibility and safety of the BCP-MFAT combination. The secondary objective will be efficacy, which will be evaluated using radiographic imaging and histological and histomorphometric evaluation of biopsies taken 6 months postoperatively, concomitant with dental implant placement.
METHODS: Eight patients with alveolar cleft (≥15 years) will be included in this prospective, nonblinded, first-in-human clinical
study. MFAT will be prepared intraoperatively from the patient\'s own buccal fat pad. Regular blood tests and physical examinations will be conducted, and any adverse events (AEs) or serious EAs (SAEs) will be meticulously recorded. Radiographic imaging will be performed prior to surgery and at regular intervals after reconstruction of the alveolar cleft with the BCP-MFAT combination. Biopsies obtained after 6 months with a trephine drill used to prepare the implantation site will be assessed with histological and histomorphometric analyses after methylmethacrylate embedding and sectioning.
RESULTS: The primary outcome parameter will be safety after 6 months\' follow-up, as monitored closely using possible occurrences of SAEs based on radiographic imaging, blood tests, and physical examinations. For efficacy, radiographic imaging will be used for clinical grading of the bone construct using the Bergland scale. In addition, bone parameters such as bone volume, osteoid volume,
graft volume, and number of osteoclasts will be histomorphometrically quantified. Recruitment started in November 2019, and the
trial is currently in the follow-up stage. This protocol\'s current version is 1.0, dated September 15, 2019.
CONCLUSIONS: In this first-in-human
study, not only safety but also the histologically and radiographically assessed regenerative potential of the BCP-MFAT combination will be evaluated in an alveolar cleft model. When an SAE occurs, it will be concluded that the BCP-MFAT combination is not yet safe in the current setting. Regarding AEs, if they do not occur at a higher frequency than that in patients treated with standard care (autologous bone) or can be resolved by noninvasive conventional methods (eg, with analgesics or antibiotics), the BCP-MFAT combination will be considered safe. In all other cases, the BCP-MFAT combination will not yet be considered safe.
BACKGROUND: Indonesia Clinical
Trial Registry INA-EW74C1N; https://tinyurl.com/28tnrr64.
UNASSIGNED: DERR1-10.2196/42371.