间充质干细胞治疗的安全性及伦理问题探讨

Safety and Ethical Issues in Mesenchymal Stem Cell Therapy

间充质干细胞(Mesenchymal stem cells,MSC)的免疫调节、造血支持及促血管新生的功能特点,使其成为继造血干细胞之后又一个有望应用于临床的成体干细胞。有些国家已经批准MSC作为药物,用于治疗移植物抗宿主病、克隆氏病、骨关节炎等疾病;同时,数百个临床试验也在进行中,上万人已经接受了MSC治疗。然而,MSC本身及其治疗过程,都可能引起相应的毒副反应,甚至产生致命的并发症。因此,在MSC治疗某些疾病效果尚存在争议的情况下,进行这种新型细胞治疗的临床试验,应重视符合医学伦理规范的受试者知情权保护。参试者有权了解细胞治疗细节及其可能机制,潜在的风险及规避措施,其他可以采用的治疗手段及其与细胞治疗的比较等细节,以切实保护受试者权益。

The characteristics of mesenchymal stem cell （MSC）, including immuno-regulatory, hematopoiesis-supporting and angiogenesis-promoting activities endow it to be the second candidate of adult stem cells beyond hematopoietic stem cells in clinical application. MSC, as a cellular drug, has been officially approved by some governments to treat graft-versus- host disease, Crohn＇s disease and osteoarthritis. Meanwhile, hundreds of clinical trials have been ongoing and thousands of subjects have received MSC therapy. However, it should be noted that serious or even fatal side effects and complications might occur, being aroused by MSC itself and the process of MSC therapy. Therefore, the informed consent of the subjects enrolled in a clinical trial should be reinforced especially the efficacies of MSC therapy on a disease are still in controversy. To rigorously protect the interest of the patients, the details of the therapy including the rationale of the treatment, the potential risks and the measurements that will be taken, and the current managements and their differences from the tested trial, should be readily accessible and comprehensible to the enrolled subjects.