Picardi A, Ferraro A S, Miranda M, Meconi F, Lanti A, Adorno G, Arcese W, Bollero P
Stem Cell Transplant Unit, Hematology, Department of Biomedicine and Prevention, University of Rome "Tor Vergata", Rome, Italy.
Blood Bank, Fondazione "Policlinico Tor Vergata", Rome, Italy.
Oral Implantol (Rome). 2017 Jan 21;10(4):398-405. doi: 10.11138/orl/2017.10.4.398. eCollection 2017 Oct-Dec.
Platelet (PLT) gel has been successfully used in tissue regeneration of diabetic and surgical wounds through the releasing of growth factors such as basic fibroblast and PLT-derived growth factors. Based on this background, our previous clinical trial have assessed the feasibility and efficacy of PLT gel for the treatment of muco-cutaneous lesions related to graft versus host disease (GvHD) after allogeneic haematopoietic stem cell transplantion (HSCT). The promising results reported in a small series of 6 patients, of whom 1 with oral ulcers, represent the rationale of the present study.
The aim of this study was to verify the efficacy and safety of PLT gel for treating oral ulcers due to chronic GvHD. Allogeneic hemocomponents were used to obtain PLT gel with an automated system for the on-site preparation and application of patient (autologous) or healthy blood donor (allogeneic)-derived fibrin sealant or PLT-rich fibrin (Vivostat system, Vivostat A/S). Ten patients with multiple oral lesions related to chronic GvHD underwent allogeneic PLT gel as local therapy alone or in combination with systemic therapy in half of the cases.
After the second PLT gel application, all patients resumed the feeding and a significant improvement of the oral pain was observed. After a median of five PLT gel applications (range, 2-15), 7 out of 10 patients showed a complete response. No side effects were documented.
These data confirm that the PLT gel may be used as a safe and effective tool, alone or in combination with systemic therapy, for the treatment of mucosal lesions of mouth related to cGvHD.
血小板(PLT)凝胶已通过释放碱性成纤维细胞生长因子和血小板衍生生长因子等生长因子,成功应用于糖尿病伤口和手术伤口的组织再生。基于此背景,我们之前的临床试验评估了PLT凝胶治疗异基因造血干细胞移植(HSCT)后移植物抗宿主病(GvHD)相关黏膜皮肤损伤的可行性和疗效。在一小系列6例患者(其中1例患有口腔溃疡)中报告的有前景的结果,构成了本研究的理论基础。
本研究的目的是验证PLT凝胶治疗慢性GvHD所致口腔溃疡的疗效和安全性。使用异基因血液成分,通过自动化系统现场制备和应用患者(自体)或健康献血者(异体)来源的纤维蛋白密封剂或富含血小板的纤维蛋白(Vivostat系统,Vivostat A/S)来获得PLT凝胶。10例患有与慢性GvHD相关的多发性口腔损伤的患者接受了异体PLT凝胶治疗,其中一半病例单独作为局部治疗,另一半病例与全身治疗联合使用。
在第二次应用PLT凝胶后,所有患者恢复进食,口腔疼痛明显改善。在中位5次PLT凝胶应用(范围2 - 15次)后,10例患者中有7例显示完全缓解。未记录到副作用。
这些数据证实,PLT凝胶可单独或与全身治疗联合用作治疗与慢性移植物抗宿主病相关的口腔黏膜损伤的安全有效工具。