Regulski Matthew J, Saunders Molly C, McCulloch Sharron E, Danilkovitch Alla
From Ocean County Foot & Ankle Surgical Associates, P.C., Forked River, NJ.
Britecyte, Inc., Frederick, MD.
Plast Reconstr Surg Glob Open. 2024 Dec 26;12(12):e6404. doi: 10.1097/GOX.0000000000006404. eCollection 2024 Dec.
Loss or displacement of a fat pad on the foot increases plantar pressure, leading to pain and plantar ulcers. These ulcers, especially in patients with diabetic neuropathy, have high recurrence rates, often resulting in amputations. Standard of care focuses on reducing plantar pressure with shoe padding or orthotic devices, leaving the restoration of the fat pad as an unmet medical need. To address this, a human cryopreserved adipose tissue (hCAT) allograft has been developed to repair adipose tissue defects.
Scientific characterization of hCAT included assessments of its structural properties, immunogenicity, persistence, and remodeling in both in vitro and in vivo models. The incidence of adverse events and ulcer recurrence was analyzed retrospectively in 12 patients with diabetic neuropathy with preulcerative lesions who received 1.5-3.0 mL subcutaneous hCAT implants in areas with fat pad defects.
When implanted in patients, hCAT remained palpable at the implantation sites, and no ulcerations occurred for an average of 6.4 months (range, 2-10 months). No product-related adverse events have been recorded to date. Long-term follow-up for implanted patients is ongoing.
Use of hCAT seems to be safe and potentially beneficial for managing patients at risk for plantar ulcerations. Further studies are warranted to evaluate hCAT's potential to manage patients at high risk for plantar ulcer formation.
足部脂肪垫的缺失或移位会增加足底压力，导致疼痛和足底溃疡。这些溃疡，尤其是糖尿病神经病变患者的溃疡，复发率很高，常常导致截肢。护理标准侧重于使用鞋垫或矫形器械来降低足底压力，而脂肪垫的修复仍是未满足的医疗需求。为了解决这一问题，已开发出一种人冷冻保存脂肪组织（hCAT）同种异体移植物来修复脂肪组织缺损。
hCAT的科学特性包括在体外和体内模型中对其结构特性、免疫原性、持久性和重塑的评估。对12例患有糖尿病神经病变且有溃疡前期病变的患者进行回顾性分析，这些患者在脂肪垫缺损部位接受了1.5 - 3.0毫升皮下hCAT植入，分析不良事件发生率和溃疡复发情况。
当植入患者体内时，hCAT在植入部位仍可触及，平均6.4个月（范围为2 - 10个月）未发生溃疡。迄今为止，未记录到与产品相关的不良事件。对植入患者的长期随访正在进行中。
使用hCAT似乎对管理有足底溃疡风险的患者是安全且可能有益的。有必要进一步研究以评估hCAT对管理有高足底溃疡形成风险患者的潜力。
