A Phase 1 Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Tolerability of a Single Intravenous Infusion of BX-U001, a Human Umbilical Cord Tissue Derived Mesenchymal Stem Cell Product, for Refractory Rheumatoid Arthritis

This is a phase 1, randomized, placebo-controlled, double-blind, single-dose, clinical trial examining the safety and biological effects of allogeneic fresh human umbilical cord tissue-derived mesenchymal stem cell product BX-U001, given by intravenous (IV) infusion, to rheumatoid arthritis (RA) patients with moderate to severe disease activity, who are not well controlled by their current treatments. Two doses of BX-U001 will be tested in 16 patients. The subjects will receive a one-time IV infusion of BX-U001 and monitored for 52 weeks.

开始日期2024-12-01

申办/合作机构

Baylx, Inc.

NCT04452097 / Not yet recruiting临床1/2期

A Phase 1/2a Study of the Safety and Efficacy of BX-U001 for the Treatment of Severe COVID-19 Pneumonia With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS).

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.

开始日期2024-12-01

申办/合作机构

Baylx, Inc.

CTR20233420 / Recruiting临床1期

人脐带间充质干细胞注射液治疗特发性肺纤维化的 I/IIa 期临床试验

主要目的：评估BC-U001治疗IPF的安全性和耐受性。次要目的：探索BC-U001治疗IPF的有效性和适宜剂量，并初步探索BC-U001的人体药代动力学（PK）特征。(第一阶段）

开始日期2023-11-20

申办/合作机构

北京贝来生物科技有限公司

100 项与 BX-U001 相关的临床结果

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100 项与 BX-U001 相关的转化医学

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100 项与 BX-U001 相关的专利（医药）

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项与 BX-U001 相关的文献（医药）

2020-01-01·Cell Transplantation3区 · 医学

Preclinical Evaluation of a Single Intravenous Infusion of hUC-MSC (BX-U001) in Rheumatoid Arthritis

3区 · 医学

ArticleOA

作者: Nguyen, Brenda ; Liu, Linan ; Liao, Wenbin ; Zhao, Weian ; Nguyen, Agnes ; Nguyen, Lily ; Liu, Guangyang ; Han, Menglu ; Farhoodi, Henry P ; Yu, Jingxia

Rheumatoid arthritis (RA) is an inflammatory disease of the joints, which causes severe pain and excessive systemic circulation of harmful inflammatory cytokines. Current treatments are limited, with some patients not responding well, and some experiencing severe and detrimental side effects. Mesenchymal stem cells (MSC) are cell-based therapeutics being evaluated as potent immunomodulators in RA and may provide relief to patients not responding well to drug-based treatments. We evaluated the safety and efficacy of BX-U001 human umbilical cord tissue–derived mesenchymal stem cells (hUC-MSC) to treat RA, in support of a successful investigational new drug application. A collagen-induced arthritis (CIA) mouse model of RA was established in DBA/1 J mice. Mice from the treatment assessment group were given a tail vein infusion of hUC-MSC 24 days after primary RA induction, while control assessment (CA) group mice were given cell-free carrier solution. All animals were evaluated daily for RA symptoms via clinical scoring, blood was taken periodically for cytokine analysis, and mice were dissected at end point for histological analysis. A linear mixed model was used to compare the rate of change among groups. The clinical scores of TA group were significantly reduced compared with CA group ( P < 0.01), indicating therapeutic effects. The histological scores of the joints in TA group were significantly lower than those in the CA group ( P < 0.05), but had no significant difference compared with Healthy groups ( P > 0.05). The concentration of (interleukin) IL-6 in TA group was significantly reduced by 80.0% ( P < 0.0001) 2 days after treatment and by 93.4% at the experimental endpoint compared with levels prior to hUC-MSC injection. A single intravenous infusion of hUC-MSC (2 × 106 cells/mouse), to CIA-induced DBA/1 J mice, resulted in significant alleviation of RA symptoms and may provide significant therapeutic benefits in humans.

100 项与 BX-U001 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
新型冠状病毒感染	临床2期	-	Baylx, Inc.	2024-12-01
急性呼吸窘迫综合征	临床2期	-	Baylx, Inc.	2024-12-01
类风湿关节炎	临床2期	中国	北京贝来生物科技有限公司	2021-04-12
特发性肺纤维化	临床1期	中国	北京贝来生物科技有限公司	2023-11-20
炎症性肠病	临床前	美国	Baylx, Inc.	-
多发性硬化症	临床前	美国	Baylx, Inc.	-