Cell Therapy Center, University of Jordan, Amman; Department of Medical laboratories, American University of Madaba, Madaba, Jordan.
Department of Cardiac Vascular Surgery/General Surgery, Jordan University Hospital, Amman, Jordan.
Indian J Med Res. 2022 Feb;155(2):273-279. doi: 10.4103/ijmr.IJMR_1441_19.
BACKGROUND & OBJECTIVES: Platelet concentrate contains a rich cocktail of growth factors that support growth and proliferation of cells. The primary goal of this study was to investigate the safety of platelet lysate (PL) in patients with critical limb ischaemia (CLI) not suitable for standard revascularization. Data on the preliminary efficacy are also presented.
Seven patients (18-70 yr) with CLI classified in the Rutherford grades 3-5, with history of intermittent claudication for more than eight weeks and were not suitable for standard revascularization, underwent autologous intramuscular injections of PL. These patients were examined physically alongside other parameters such as TcPO2, toe pressure, and ankle brachial index, at baseline and were followed up for 12 months.
The procedure was well tolerated with no serious adverse or any adverse events reported during follow up. Although not the primary aim of this report, preliminary data showed significant clinical improvement in Rutherford stage, ankle-brachial index and toe pressure which persisted for a year.
INTERPRETATION & CONCLUSIONS: Intramuscular injection of PL was well tolerated with no major adverse events reported in our study participants. With the observed satisfactory safety data, preliminary efficacy data of PL should be further validated.
血小板浓缩物含有丰富的生长因子鸡尾酒，可支持细胞的生长和增殖。本研究的主要目的是调查不适合标准血运重建的严重肢体缺血（CLI）患者使用血小板裂解液（PL）的安全性。同时也呈现了初步疗效的数据。
7 名（18-70 岁）CLI 患者（Rutherford 分级 3-5 级），间歇性跛行病史超过 8 周，不适合标准血运重建，接受自体肌肉内注射 PL。这些患者在基线时进行体格检查和其他参数检查，如 TcPO2、脚趾压力和踝肱指数，并随访 12 个月。
该过程耐受良好，随访期间未报告任何严重不良事件或任何不良事件。虽然这不是本报告的主要目的，但初步数据显示 Rutherford 分期、踝肱指数和脚趾压力有显著的临床改善，且持续了一年。
在我们的研究参与者中，肌肉内注射 PL 耐受良好，未报告重大不良事件。鉴于观察到的安全性数据令人满意，PL 的初步疗效数据应进一步验证。
