A Phase IIa, Dose-Escalation Followed by Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients

This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.

开始日期2023-09-24

申办/合作机构

长圣国际生技股份有限公司

NCT05532943 / Recruiting临床1/2期

A Seamless Phase I/IIa Clinical Study to Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis

This study is to identify the safety and efficacy of repeat IV(Intravenous) and IT(Intrathecal) administrations of UMSC01 in patients with MS. While anti-inflammatory drugs are routinely used for the treatment of MS by inhibiting immune responses, their effects on axon remyelination or neuroregeneration are limited. The combined systemic delivery of UCMSCs via intravenous injection and local administration of the cells by IT was to have safety and therapeutic efficacy for patients with MS.

开始日期2023-09-08

申办/合作机构

长圣国际生技股份有限公司

NCT04434768 / Recruiting临床1期

A Phase I, Open Label Study to Evaluate the Safety and to Explore the Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients with Acute Ischemic Stroke

This study is a first-in-human assessment of safety of using umbilical cord mesenchymal stem cells (UCMSCs) in patients with Acute Ischemic Stroke via a combination of intra arterial (IA) and intravenous (IV) stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IA and IV had never been conducted in humans, there may be unknown risks to humans not predicted from the preclinical studies. However, the risk to patients in this trial will be minimized by rigorous adherence to the eligibility criteria, use of appropriate dose and concentration of stem cells, standardized techniques of stem cell infusion, and intensive patient monitoring during and after stem cell infusion.

开始日期2020-12-02

申办/合作机构

长圣国际生技股份有限公司

100 项与 UMSC-01 相关的临床结果

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100 项与 UMSC-01 相关的转化医学

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100 项与 UMSC-01 相关的专利（医药）

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项与 UMSC-01 相关的文献（医药）

Frontiers in cardiovascular medicine

First-in-human pilot trial of combined intracoronary and intravenous mesenchymal stem cell therapy in acute myocardial infarction

Article

作者: Lin, Yen-Nien ; Chang, Shih-Sheng ; Chiu, Lu-Ting ; Cho, Der-Yang ; Tseng, Wen-Yih I ; Chang, Kuan-Cheng ; Lu, Chiung-Ray ; Lin, Yu-Kai ; Chen, Chien-Lin ; Hsu, Chin-Ting ; Tsai, Cheng-Kang ; Lin, Cheng-Li ; Shyu, Woei-Cherng ; Hsiao, Lien-Cheng ; Su, Mao-Yuan ; Hu, Kai-Chieh ; Chen, Jan-Yow ; Wu, Mei-Yao ; Tsai, Chang-Hai ; Li, Keng-Yuan ; Wang, Yu-Chen ; Jeng, Long-Bin ; Ho, Ming ; Lu, Shang-Yeh

Background:

Acute ST-elevation myocardial infarction (STEMI) elicits a robust cardiomyocyte death and inflammatory responses despite timely revascularization.

Objectives:

This phase 1, open-label, single-arm, first-in-human study aimed to assess the safety and efficacy of combined intracoronary (IC) and intravenous (IV) transplantation of umbilical cord-derived mesenchymal stem cells (UMSC01) for heart repair in STEMI patients with impaired left ventricular ejection fraction (LVEF 30-49%) following successful reperfusion by percutaneous coronary intervention.

Methods:

Consenting patients received the first dose of UMSC01 through IC injection 4-5 days after STEMI followed by the second dose of UMSC01 via IV infusion 2 days later. The primary endpoint was occurrence of any treatment-related adverse events and the secondary endpoint was changes of serum biomarkers and heart function by cardiac magnetic resonance imaging during a 12-month follow-up period.

Results:

Eight patients gave informed consents, of whom six completed the study. None of the subjects experienced treatment-related serious adverse events or major adverse cardiovascular events during IC or IV infusion of UMSC01 and during the follow-up period. The NT-proBNP level decreased (1362 ± 1801 vs. 109 ± 115 pg/mL, p = 0.0313), the LVEF increased (52.67 ± 12.75% vs. 62.47 ± 17.35%, p = 0.0246), and the wall motion score decreased (26.33 ± 5.57 vs. 22.33 ± 5.85, p = 0.0180) at the 12-month follow-up compared to the baseline values. The serial changes of LVEF were 0.67 ± 3.98, 8.09 ± 6.18, 9.04 ± 10.91, and 9.80 ± 7.56 at 1, 3, 6, and 12 months, respectively as compared to the baseline.

Conclusion:

This pilot study shows that combined IC and IV transplantation of UMSC01 in STEMI patients with impaired LVEF appears to be safe, feasible, and potentially beneficial in improving heart function. Further phase 2 studies are required to explore the effectiveness of dual-route transplantation of UMSC01 in STEMI patients.

100 项与 UMSC-01 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
ST段抬高心肌梗死	临床2期	中国台湾	长圣国际生技股份有限公司	2023-09-24
新型冠状病毒感染	临床2期	中国台湾	长圣国际生技股份有限公司	2020-08-05
心肌梗塞	临床2期	-	长圣国际生技股份有限公司	-
缺血性卒中	临床1期	中国台湾	长圣国际生技股份有限公司	2020-05-05
缺血性卒中	临床1期	中国台湾	China Medical University (Taiwan)	2020-05-05