McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, Toronto, ON, M5G 1L7, Canada.
Regen Med. 2010 Nov;5(6):863-76. doi: 10.2217/rme.10.76.
Although Brazil has received attention for conducting one of the world's largest stem cell clinical trials for heart disease, little has been published regarding Brazil's regenerative medicine (RM) sector. Here we present a comprehensive case study of RM in Brazil, including analysis of the current activity, the main motivations for engaging in RM and the remaining challenges to development in this field.
Our case study is primarily based on semi-structured interviews with experts on RM in Brazil, including researchers, policymakers, clinicians, representatives of firms and regulators.
Driven by domestic health needs and strategic government support, Brazil is producing innovative RM research, particularly for clinical research in cardiology, orthopedics, diabetes and neurology. We describe the main RM research currently taking place in Brazil, as well as some of the economic, regulatory and policy events that have created a favorable environment for RM development. Brazilian RM researchers need to overcome several formidable challenges to research: research funding is inconsistent, importation of materials is costly and slow, and weak linkages between universities, hospitals and industry impede translational research.
Although Brazil's contribution to the RM sector is small, its niche emphasis on clinical applications may become of global importance, particularly if Brazil manages to address the challenges currently impinging on RM innovation.
尽管巴西因开展世界上最大的心脏病干细胞临床试验之一而受到关注，但关于巴西再生医学（RM）领域的信息却很少。本文对巴西的 RM 进行了全面的案例研究，包括对当前活动的分析、从事 RM 的主要动机以及该领域发展面临的剩余挑战。
我们的案例研究主要基于对巴西 RM 专家的半结构化访谈，包括研究人员、政策制定者、临床医生、公司和监管机构的代表。
受国内卫生需求和政府战略支持的推动，巴西正在开展创新性的 RM 研究，特别是在心脏病学、骨科、糖尿病和神经病学的临床研究方面。我们描述了巴西目前正在进行的主要 RM 研究，以及一些为 RM 发展创造有利环境的经济、监管和政策事件。巴西 RM 研究人员需要克服研究方面的几个严峻挑战：研究资金不稳定，材料的进口既昂贵又缓慢，大学、医院和工业之间的联系薄弱，阻碍了转化研究。
尽管巴西对 RM 部门的贡献很小，但它在临床应用方面的特色重点可能会变得具有全球重要性，特别是如果巴西能够解决当前影响 RM 创新的挑战。
