2022年3月2日 · 干细胞药物Alofisel (darvadstrocel，又名Cx601)用于治疗克罗恩病复杂性肛周瘘，是日本武田制药（Takeda）和比利时干细胞公司TiGenix开发的产品。 2021年，Alofisel在日本厚生劳动省提交了生产和销售的申请。

2023年10月17日 · Alofisel® (darvadstrocel) is a dispersion of expanded allogeneic (or donor-derived), adipose-derived mesenchymal stem cells (eASC) for the treatment of complex CPF in adult patients with non-active or mildly active luminal Crohn’s disease (CD). 1 It is the first allogeneic stem cell therapy to receive centralized marketing authorization ...

2018年4月4日 · Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.

2024年12月13日 · Alofisel® (darvadstrocel) is a dispersion for injection of expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease.

Darvadstrocel, sold under the brand name Alofisel, is a medication used to treat complex perianal fistulas in adults with non-active/mildly active luminal Crohn's disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy. [1] It contains mesenchymal stem cells from fat tissue of adult donors. [2]

Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used only after conditioning of the fistulas (see section 4.2).

2022年2月18日 · Approved in the European Union/European Economic Area, Israel, Switzerland, United Kingdom and Japan, Alofisel, an Expanded Human Allogeneic Adipose-Derived Mesenchymal Stem Cell Therapy, Offers a Potential Cell-Mediated Closure Option for Patients with Complex Crohn’s Perianal Fistulas Who Have …

2023年10月21日 · Alofisel®（darvadstrocel）是一种扩增的异体（或供体来源）脂肪间充质干细胞（eASC）分散液，用于治疗非活动性或轻度活动性腔隙性克罗恩病（CD）成年患者的复杂CPF。

Alofisel是一种局部注射的同种异体脂肪源性 干细胞 悬浮液，这是一种从人体脂肪组织中分离并在体外培养扩增的脂肪源性 干细胞 （ASC），ASC分泌的细胞因子具有调节免疫系统和抑制炎症的作用，因此被认为具有治疗CD患者CPF的潜力。 2018年3月，Alofisel成为第一个获得欧盟集中营销授权批准的同种异体 干细胞 疗法。 2019年，美国 FDA 授予了Alofisel治疗CD成人患者CPF的 再生医学 先进疗法（RMAT）资格。 2021年9月，Alofisel成为日本批准的第一种扩增的人类 …

2023年10月19日 · Alofisel (daradstrocel), a stem cell therapy designed to treat one of the most debilitating complications of Crohn’s—complex perianal fistulas (CPF)—has come up short in a phase 3 trial. In the...