MULHOUSE, France, and SUNNYVALE, Calif., July 08, 2024 (GLOBE NEWSWIRE) -- Cellprothera, a private company specializing in cell-based therapies for repairing ischemic tissues, and BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announce success from a collaborative Phase II trial of ProtheraCytes for the treatment of acute myocardial infarction (AMI) led by CellProthera, as well as plans to continue the relationship into Phase III..

法国穆尔豪斯（MULHOUSE）和加利福尼亚州桑尼维尔（SUNNYVALE），2024年7月8日（Global NEWSWIRE）--Cellprothera是一家专门从事修复缺血组织的细胞疗法的私营公司，BioCardia，Inc.[纳斯达克：BCDA]，一家用于治疗心血管和肺部疾病的细胞和细胞衍生疗法的开发商，今天宣布由Cellprothera领导的用于治疗急性心肌梗死（AMI）的原细胞合作II期试验取得成功，并计划将这种关系延续到III期。。

CellProthera’s clinical results from the Phase I/IIb EXCELLENT Trial, which studied the feasibility of transendocardial injection of ProtheraCytes for acute myocardial infarction when delivered in combination with the standard of care, suggested an effective solution for preventing heart failure progression in the patients at high risk following a heart attack..

CellProthera的I/IIb期卓越试验的临床结果研究了经心内膜注射前体细胞治疗急性心肌梗死的可行性，并结合标准护理，为预防心脏病发作后高危患者的心力衰竭进展提供了有效的解决方案。。

The ProtheraCytes, which are autologous, expanded CD34+ stem cells, were well tolerated with no unexpected serious adverse events reported. Transendocardial administration of ProtheraCytes, performed utilizing the percutaneous catheter delivery system from BioCardia, was associated with improvements in multiple efficacy endpoints including a significant improvement of the viability of segments from baseline to six months, a consistent positive trend of improvement of LV volumes at six months, and a faster decrease in an important biomarker of heart failure, NTproBNP..

自体扩增的CD34+干细胞的原始细胞耐受性良好，没有意外的严重不良事件报道。利用BioCardia的经皮导管输送系统进行的经心内膜给药与多个疗效终点的改善相关，包括从基线到六个月的节段活力的显着改善，六个月时LV体积改善的一致积极趋势，以及心力衰竭的重要生物标志物NTproBNP的更快下降。。

“The promising results of the study confirm the potential of our therapy to provide an effective one-off solution to prevent heart failure progression in AMI patients,” said Matthieu de Kalbermatten, CEO, CellProthera. “We are actively planning for what comes next and we have valued the responsiveness of the BioCardia team throughout the EXCELLENT trial in supporting training, attending clinical cases, and providing delivery systems.

CellProthera首席执行官Matthieu de Kalbermaten说：“这项研究的有希望的结果证实了我们的治疗方法有潜力提供一种有效的一次性解决方案来预防AMI患者的心力衰竭进展。”。“我们正在积极规划下一步的工作，我们重视BioCardia团队在支持培训、参与临床病例和提供分娩系统方面的出色试验中的反应能力。

We have great learnings today that will enhance our efforts in what comes next, together.”.

我们今天学到了很多东西，这将加强我们在接下来的工作中的努力。”。

“The EXCELLENT trial has meaningful results for patient benefit using an approach that we feel makes enormous sense for locally administered high effective dosage of autologous CD34+ cells for these patients,” said Peter Altman, PhD, President and CEO of BioCardia. “I am personally impressed by their approach.

BioCardia总裁兼首席执行官彼得·奥特曼（PeterAltman）博士说：“这项出色的试验为患者带来了有意义的结果，我们认为这种方法对于这些患者局部施用高效剂量的自体CD34+细胞非常有意义。”。“我个人对他们的做法印象深刻。

It has been an honor to support CellProthera and we look forward to collaborating in the study to follow. We are ready for what comes next with enhancements to our delivery capabilities.”.

很荣幸能支持CellProthera，我们期待着在接下来的研究中合作。我们已经准备好了接下来要做的事情，即增强我们的交付能力。”。

About CellProthera

关于CellProthera

CellProthera is a regenerative cell therapy developer specializing in cardiovascular diseases with a leading program in myocardial infarction. CellProthera has developed a unique GMP-compliant cell expansion process as well as a proprietary automation technology for in vitro production of large quantity of purified, CD34+ stem cells.

CellProthera是一家专门研究心血管疾病的再生细胞疗法开发公司，拥有领先的心肌梗塞项目。CellProthera开发了一种独特的符合GMP的细胞扩增工艺，以及专有的自动化技术，用于体外生产大量纯化的CD34+干细胞。

Its lead therapy ProtheraCytes™, is an autologous cell therapy and has been developed for body regeneration and targeted to regenerate various damaged tissues, including cardiac tissue. ProtheraCytes is registered as an Advanced Therapy Medicinal Product by the European Medicines Agency (EMA). CellProthera’s proprietary technology platform comprises an automated expansion device called StemXpand® and its disposable kit StemPack®.

它的铅疗法ProtheraCytes™是一种自体细胞疗法，已被开发用于身体再生，并靶向再生各种受损组织，包括心脏组织。ProtheraCytes被欧洲药品管理局（EMA）注册为高级治疗药物产品。CellProthera的专有技术平台包括一种称为StemXpand®的自动扩展设备及其一次性套件StemPack®。

CellProthera is headquartered in France..

CellProthera总部位于法国。。

About BioCardia

关于BioCardia

BioCardia, Inc., is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs..

BioCardia，Inc.正在开发用于治疗心血管和肺部疾病的细胞和细胞衍生疗法。CardiAMP™自体和CardiALLO同种异体细胞疗法是该公司正在开发的三种临床阶段候选产品的生物治疗平台。BioCardia还与其他生物治疗公司合作，为其项目提供交付系统和开发支持。。