Human blood-derived endothelial colony forming cells as a new cell therapy for chronic non-healing wounds

慢性无法愈合的伤口被认为是一种无声而昂贵的流行病。在英国，仅在2012年，NHS就治疗了220万名受伤的成年患者，花费了50亿英镑。此外，糖尿病溃疡等慢性伤口难以愈合，这对患者来说是一种负担。因此，临床需要新的治疗方法来提高治愈率。这个项目将使用再生医学方法来改善伤口的愈合。80-90%的腿部溃疡是由血管疾病引起的，新血管的形成被认为是伤口有效愈合的关键因素。因此，我们提出了一种血管干细胞治疗慢性伤口的方法：使用从人血液中分离出来的内皮集落形成细胞（ecfc）。我们和其他人已经证明，ecfc是内皮祖细胞的一种亚型，在血管再生方面具有最大的治疗潜力。将ecfc直接注入病变组织，如肢体和视网膜，具有修复血管和逆转组织损伤的潜力。本项目是一项可行性研究，旨在证明ecfc在糖尿病创面中的治疗作用。为了进一步开发ecfc作为一种可行的细胞疗法，我们将开发一种效价测定法来测试ecfc的效率。这对于建立质量保证和满足法规要求非常重要。

Chronic non-healing wounds are considered a silent and expensive epidemic. In the UK, the NHS treated 2.2 million adult patients with wounds in 2012 alone at a cost of £5.0 billion. In addition, chronic wounds such as diabetic ulcers are difficult to heal and this is burdensome to patients. Therefore, there is an unmet clinical need for new therapies to improve healing rates. This project will use regenerative medicine approaches to improve healing of wounds.80-90% of leg ulcers are caused by vascular disease, and new blood vessel formation is considered a key factor for effective wound healing. Hence, we propose a vascular stem cell therapy for chronic wounds: using cells called endothelial colony forming cells (ECFCs) isolated from human blood. We and others have demonstrated that ECFCs are a subtype of endothelial progenitor with the most therapeutic potential for blood vessel regeneration. ECFCs injected directly into diseased tissues such as the limb and retina have potential to repair blood vessels and reverse tissue damage. This project is a feasibility study to demonstrate that ECFCs have a therapeutic role in diabetic wounds. To further develop ECFCs as a viable cell therapy, we will develop a Potency Assay to test the efficiency of ECFCs to perform. This is important to establish a quality assurance and to meet regulatory requirements.