澳大利亚批准StemSmart干细胞疗法为克罗恩重症患者提供特殊治疗。
Australia approves StemSmart stem cell therapy for severe Crohn’s disease under special access.
神经科学生物制药公司已获得澳大利亚的监管批准, 开始在特别准入方案下, 使用其干细胞疗法StemSmart治疗严重的克罗恩病患者。
NeuroScientific Biopharmaceuticals has gained Australian regulatory approval to begin treating severe Crohn’s disease patients with its stem cell therapy, StemSmart, under a special access program.
这种疗法来自成人骨髓干细胞,通过专有方法处理,现已在临床早期使用。
The therapy, derived from adult bone marrow stem cells and processed via a proprietary method, is now in early clinical use.
该公司计划在2026年年中之前进行第二阶段试验,正在通过昆士兰新购置的设施扩大生产规模。
The company plans a Phase 2 trial by mid-2026 and is scaling production through a newly acquired facility in Queensland.
StemSmart正在发展成为对选择有限的病人的一流治疗,可能用于肾移植、肺病和移植寄生虫病,到2030年代全球市场上有数十亿人受益。
StemSmart is being developed as a first-in-class treatment for patients with limited options, with potential applications in kidney transplants, lung disorders, and graft-versus-host disease, targeting billions in global markets by the 2030s.