Development of Angicyte, a new vasoreparative cell therapy for chronic non healing wounds (“Angicyte_BMC”)
Development of Angicyte, a new vasoreparative cell therapy for chronic non healing wounds (“Angicyte_BMC”)
批准号:
10026617
负责人:
金额:
$102.83万
依托单位:
依托单位国家:
英国
项目类别:
Collaborative R&D
财政年份:
2022
资助国家:
英国
项目状态:
未结题
起止时间:
2022 至 --
中文摘要
VascVersa正在开发一种革命性的新细胞疗法,用于治疗慢性不可愈合的伤口,特别是糖尿病足溃疡(DFU)和腿部溃疡。尽管进行了大量的医学研究,但目前可用的治疗方法并不充分,39%的已治疗伤口仍无法愈合,这主要是由于缺乏血液供应。在英国和全球,糖尿病溃疡仍然是一个巨大的医疗负担。在英国,近50万人正在遭受这些痛苦和难以愈合的创伤。这种情况深刻地影响了患者的生活质量,限制了他们的工作能力。如果不治疗,这种情况可能会导致截肢和预期寿命缩短。除了社会经济成本,NHS的财政负担也是巨大的,每年超过10亿GB。这些问题在世界范围内反复出现,并随着糖尿病患者数量的增加而恶化--据估计,到2030年,全球糖尿病人口将达到5.78亿。糖尿病患者有无法愈合的伤口或溃疡,血管愈合是有缺陷的。VascVersa的产品Angicyte是一种细胞疗法,将通过促进新血管的形成来解决这一问题。该公司和贝尔法斯特女王大学的研究证实,Angicyte可以促进血管修复。血管细胞是由捐赠的脐带血生成的。在合适的实验室条件下,每一次脐带血捐赠都可以迅速扩大,以提供足够的细胞来治疗大量患者。在这个为期24个月的项目中,VascVersa将与一些专门从事细胞治疗的英国领先研究机构合作,为其第一次临床试验做准备。除了完成监管机构MHRA要求的进一步临床前研究以证明该产品的有效性和安全性外,该项目还将使VascVersa能够开发一种强大的、临床兼容的、更自动化的制造工艺,这将是朝着临床使用的Angicyte大规模生产迈出的重要一步,所有这些都将支持VascVersa,以实现在2025年进行第一次临床研究的目标。
英文摘要
VascVersa is developing a revolutionary new cell therapy for the treatment of chronic non-healing wounds, in particular diabetic foot ulcers (DFU) and leg ulcers. Despite immense medical research, current available treatments are inadequate and 39% of treated wounds still fail to heal, largely due to a lack of blood supply. Diabetic ulcers remain an enormous healthcare burden in the UK and globally. Almost half a million people in the UK are suffering these painful and difficult to heal wounds. This condition profoundly affects the quality of life of sufferers and limits their ability to work. If left untreated, the condition can lead to limb amputation and reduced life expectancy. As well as the socioeconomic costs, the financial burden for the NHS is enormous, over £1 billion each year. These issues are repeated worldwide and are getting worse as the number of people with diabetes increases -- the global diabetic population is estimated to reach 578 million by 2030\.Vascular healing is defective in a diabetic patient with a non-healing wound or ulcer. VascVersa's product, Angicyte, is a cell therapy which will address this by promoting the formation of new blood vessels. Research by the company and at Queen's University Belfast has established that Angicyte can promote blood vessel repair. Angicyte cells are generated from donated umbilical cord blood. Under the right laboratory conditions, each cord blood donation can be rapidly expanded to provide enough cells to treat large numbers of patients.In this 24-month project, VascVersa will work with some of the UK's leading research institutions specialising in cell therapy to prepare for its first clinical trial. As well as completing further pre-clinical research required by the regulatory authority, the MHRA, to prove the efficacy and safety of the product, the project will allow VascVersa to develop a robust, clinically compatible, more automated manufacturing process, which will be a major step towards large scale production of Angicyte for use in the clinic, all of which will support VascVersa, to achieve the objective of conducting its first clinical study in 2025\.
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