Oliveira Filho Francisco José de, Rodrigues Lenize da Silva, Amaral Sidia Maria Baptista do, Mellucci Filho Pedro Luciano, Medolago Natália Bronzatto, de Carvalho Bovolato Ana Lívia, Alvarado Rita de Cássia, Bertanha Matheus
Department of Surgery and Orthopedics, São Paulo State University - UNESP, Botucatu Medical School, Botucatu, São Paulo, Brazil.
Applied Biotechnology Laboratory, Research Nucleus of Clinical Hospital, São Paulo State University - UNESP, Botucatu Medical School, Botucatu, São Paulo, Brazil.
PLoS One. 2025 Apr 9;20(4):e0318922. doi: 10.1371/journal.pone.0318922. eCollection 2025.
Peripheral artery disease (PAD) can develop into critical limb ischemia (CLI), which is characterized by resting pain at rest, ulcerations, or gangrene, with a high risk of amputation. The optimum course of treatment at this point is arterial revascularization, although this has a significant financial cost and is not always feasible or successful in reducing pain, healing ulcers, or preventing amputations. In situations where traditional alternatives for treating PAD have been exhausted, recent developments in cell therapy may offer a viable substitute.
The purpose of this study is to assess the safety and effectiveness of using expanded autologous adipose-derived stem cells (ASCs) in cellular therapy for the treatment of PAD patients who developed chronic artery ulcers.
An open randomized clinical trial will be carried out with two groups of twenty patients with CLI: In group 1, 2g of abdominal adipose tissue will be taken to produce ASCs. These cells will then be expanded in a lab (cell processing center) for 14-21 days before being applied to the lesion using bio-dressings and perilesional subcutaneous injections. Group 2 will receive conventional treatment with hydrogel-based dressing. There will be regular clinical assessments, supplementary tests, and photo documentation. The main efficacy outcome will be partial or complete healing of the wound. Safety outcomes will be monitored for infections, gangrene, amputations, and death. Participants will be monitored for 90 days. Cases of major amputation of the studied limb will not be included. The results will be evaluated by an independent external evaluator who is blind to the groups. Considering the high prevalence and socioeconomic consequences related to CLI and limb amputation, this study is expected to provide a positive social and financial impact on the Brazilian Unified Health System. ClinicalTrials.gov: NCT06326203.
外周动脉疾病（PAD）可发展为严重肢体缺血（CLI），其特征为静息痛、溃疡或坏疽，截肢风险高。此时最佳的治疗方案是动脉血运重建，尽管这会产生巨大的经济成本，且在减轻疼痛、愈合溃疡或预防截肢方面并不总是可行或成功的。在治疗PAD的传统方法已用尽的情况下，细胞治疗的最新进展可能提供一种可行的替代方案。
本研究的目的是评估使用扩增的自体脂肪来源干细胞（ASC）进行细胞治疗，以治疗发生慢性动脉溃疡的PAD患者的安全性和有效性。
将对两组各20例CLI患者进行一项开放随机临床试验：在第1组中，将采集2g腹部脂肪组织以产生ASC。然后这些细胞将在实验室（细胞处理中心）中扩增14至21天，之后使用生物敷料和病灶周围皮下注射将其应用于病变部位。第2组将接受基于水凝胶敷料的常规治疗。将进行定期的临床评估、补充检查和照片记录。主要疗效指标将是伤口的部分或完全愈合。将监测安全性指标，包括感染、坏疽、截肢和死亡情况。将对参与者进行90天的监测。不包括所研究肢体的大截肢病例。结果将由对分组情况不知情的独立外部评估者进行评估。考虑到与CLI和肢体截肢相关的高患病率和社会经济后果，预计本研究将对巴西统一卫生系统产生积极的社会和经济影响。ClinicalTrials.gov：NCT06326203。
