Armstrong David G, Harris Steven G, Rasor Zachary, Zelen Charles M, Kim Jeehee, Swerdlow Mark, Isaac Adam L
Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, Calif.
Department of Plastic Surgery, Jefferson Surgical Clinic, Salem, Va.
Plast Reconstr Surg Glob Open. 2022 Oct 28;10(10):e4588. doi: 10.1097/GOX.0000000000004588. eCollection 2022 Oct.
Diabetic foot complications are increasingly burdensome for patients, clinicians, and society. Development of innovative therapies to support good quality basic care is a priority among those with an interest in this area. One of these involves scanning and printing tissues to match and conform to a defect (so-called 3D printing).
A single-arm pilot study of ten consecutive patients with a history of a chronic diabetic foot ulcer (DFU), treated with autologous minimally manipulated homologous adipose tissue (AMHAT), dispensed by a specialized 3D bioprinter, Dr. INVIVO, was performed. Patients with nonhealing DFUs present for more than 4 weeks and refractory to standard-of-care therapies were included. Wounds were treated with a single application of AMHAT, and then followed up weekly for up to 12 weeks, or until the wounds healed. The primary outcome measure was complete epithelialization of the wound up to 12 weeks after the treatment. Secondary outcome measures included wound size and/or volume reduction, assessment of ulcer grade, and time to closure.
Five wounds were healed by 5 weeks and one at 8 weeks. The mean percent area reduction at 12 weeks was 78.3% (SD: 33.23). Complete closure was achieved in 60% of wounds. The mean time to closure in these wounds was 49.1 days (95% CI, 29.9-68.3). No adverse events were reported.
Single treatment of bioprinted AMHAT appears to be a safe and potentially effective treatment modality for patients with chronic DFUs. Further studies are warranted to explore the full potential of 3D bioprinting for tissue repair in this high-risk population.
糖尿病足并发症对患者、临床医生和社会来说负担日益加重。开发创新疗法以支持高质量的基础护理是该领域相关人士的首要任务。其中一种方法是扫描和打印组织以匹配并贴合缺损部位（即所谓的3D打印）。
对连续10例有慢性糖尿病足溃疡（DFU）病史的患者进行了一项单臂试验研究，这些患者接受由专门的3D生物打印机Dr. INVIVO分发的自体微处理同源脂肪组织（AMHAT）治疗。纳入非愈合性DFU持续超过4周且对标准护理疗法无效的患者。伤口仅接受一次AMHAT治疗，然后每周随访长达12周，或直至伤口愈合。主要结局指标是治疗后12周内伤口完全上皮化。次要结局指标包括伤口大小和/或体积减小情况、溃疡分级评估以及愈合时间。
5个伤口在5周时愈合，1个在8周时愈合。12周时平均面积缩小百分比为78.3%（标准差：33.23）。60%的伤口实现了完全闭合。这些伤口的平均愈合时间为49.1天（95%置信区间，29.9 - 68.3）。未报告不良事件。
对于慢性DFU患者，生物打印的AMHAT单次治疗似乎是一种安全且可能有效的治疗方式。有必要进一步开展研究以探索3D生物打印在这一高危人群组织修复方面的全部潜力。
