XSTEM(XSTEM) - 在研适应症：静脉曲张溃疡，骨关节炎，膝关节炎_专利_临床

概要

基本信息

药物类型

间充质干细胞疗法

别名

XSTEM-OA、XSTEM-VLU

靶点-

作用方式-

作用机制-

治疗领域

免疫系统疾病心血管疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症

静脉曲张溃疡骨关节炎膝关节炎+ [1]

非在研适应症-

原研机构

Xintela AB

在研机构

Xindu Pty Ltd

Xintela AB

非在研机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 XSTEM 相关的临床试验

NCT05549609

/ Recruiting临床1/2期

A Multi-centre, Randomised, Single-blind Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of a Single Topical Dose of Allogeneic Integrin α10β1-selected Mesenchymal Stem Cells (XSTEM-VLU) in Patients With Difficult-to-heal Venous Leg Ulcers

The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care.
The patients will be followed weekly for 10 weeks after treatment. At 4 months after treatment, the patients will return to the clinic for an end-of-study visit.

开始日期2022-10-26

申办/合作机构

Xintela AB

[+1]

NCT05344157

/ Active, not recruiting临床1/2期

A First-in-Human Open-Label Phase 1/2a Study to Evaluate Safety, Tolerability and Efficacy of a Single Intra-Articular Injection of Allogeneic Mesenchymal Stem Cells Selected for Integrin α10β1 (XSTEM-OA) in Adult Patients With Symptomatic Knee Osteoarthritis

The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-OA when administered as a single intra-articular injection to patients with symptomatic knee osteoarthritis. The study is divided into two parts; a dose escalation (Part A) and an optional dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) may be further expanded in Part B.

开始日期2022-06-22

申办/合作机构

Xindu Pty Ltd

[+1]

100 项与 XSTEM 相关的临床结果

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100 项与 XSTEM 相关的转化医学

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100 项与 XSTEM 相关的专利（医药）

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100 项与 XSTEM 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
静脉曲张溃疡	临床2期	瑞典	Xintela AB	2022-10-26
骨关节炎	临床2期	澳大利亚	Xintela AB	2022-06-22
膝关节炎	临床2期	澳大利亚	Xindu Pty Ltd	2022-06-22
成人呼吸窘迫综合征	临床前	瑞典	Xintela AB	2024-10-08