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

慢性不愈合伤口被认为是一种无声的和昂贵的流行病。在英国，NHS仅在2012年就治疗了220万成年患者的伤口，花费了50亿英镑。此外，慢性伤口如糖尿病溃疡难以愈合，这对患者来说是负担。因此，对于提高愈合率的新疗法存在未满足的临床需求。该项目将使用再生医学方法来改善伤口愈合。80 -90%的腿部溃疡是由血管疾病引起的，新血管形成被认为是有效伤口愈合的关键因素。因此，我们提出了一种用于慢性伤口的血管干细胞疗法：使用从人血液中分离的称为内皮集落形成细胞（ECFC）的细胞。我们和其他人已经证明ECFC是内皮祖细胞的一种亚型，具有最大的血管再生治疗潜力。直接注射到患病组织（如肢体和视网膜）中的ECFC具有修复血管和逆转组织损伤的潜力。该项目是一项可行性研究，以证明ECFC在糖尿病伤口中具有治疗作用。为了进一步开发ECFC作为活细胞疗法，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监管要求非常重要。

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.