PolyU’s new Advanced Therapy Product Laboratory gives hope to spinal cord injury patients, supporting Hong Kong’s development into an international health and medical innovation hub

The Hong Kong Polytechnic University (PolyU) strives to promote educational and research development in the fields of medicine and health. Leveraging its state-of-the-art facilities and strengths in interdisciplinary research, the University is committed to supporting Hong Kong’s development into an international health and medical innovation hub by advancing precision medicine and personalised treatment.

PolyU will actively promote precision and personalised medicine through the introduction of advanced therapy products (ATPs). This initiative will promote medical innovation and interdisciplinary collaboration, accelerating the development of the local ATPs ecosystem while enhancing Hong Kong’s global competitiveness in biopharmaceuticals. The University is now planning to manufacture cell therapy products for spinal cord injuries, which will be further complemented by the post-surgery rehabilitation programme and utilise the expertise of PolyU Department of Rehabilitation Sciences (RS), offering a one-stop approach from precision medicine to rehabilitation to bring new hope to hemiplegia and paralysis patients.

The newly established PolyU Advanced Therapy Product (ATP) Laboratory is a Pharmaceutical Inspection Co-operation Scheme’s Good Manufacturing Practice (PIC/S GMP)-compliant facility, focuses on clinical research in immunotherapy, cell therapy, gene therapy and regenerative medicine. Led by Prof. Larry CHOW Ming-cheung, Head of the Department of Applied Biology and Chemical Technology, the research team has made plans to collaborate with thebiopharmaceutical industry and will commence clinical trials once the Laboratory is granted the Licence for Manufacturer and the Certificate for Clinical Trial and Medicinal Test by the HKSAR Government’s Department of Health.

Medical needs of spinal cord injury patients

The spinal cord is an essential part of the central nervous system. Any damage to it may affect the function of the spinal nerves at and below the injury site. According to the World Health Organization, more than 15 million people are living with spinal cord injuries globally. Common symptoms include tetraplegia, paraplegia, loss of sensation, impaired bladder and bowel control, chronic pain, and movement disorders, which seriously affect patients’ physical and mental health.

Currently, there is no effective cure for spinal cord injuries. The medical sector has, in recent years, endeavoured to develop technology for precision medicine, including stem cell therapy, gene therapy, biomaterials and tissue engineering, and electrical stimulation therapy, to help repair the injured spinal nerves. Previous research has indicated that, nevertheless, advanced therapy alone isnot effective enough for patients to fully regain their mobility. It has to be combined with cross-professional rehabilitation training to enhance the treatment outcomes.

PolyU ATP Laboratory: A pioneer in precision medicine

The Laboratory has been established with the grants provided by the University Grants Committee (UGC) and PolyU. Equipped with a Production Site, Quality Control Laboratory and Training Laboratory, it will serve as a robust platform for the development and clinical application of local ATPs. The ATP team, in collaboration with scientific research enterprises, the biopharmaceutical industry, and academic institutions, will focus on clinical trials for spinal cord injury patients during its first phase of work. It will make use of human leukocyte antigen (HLA)-matched umbilical cord blood received from the industry partner to produce umbilical cord blood-derived mononuclear cells. Quality control and product packaging procedures will also be performed. PIC/S GMP-compliant final products will then be sent to the hospitals for transplantation in patients.

The project will also foster collaboration on neurological disorders research at PolyU, further unleashing the University’s interdisciplinary strengths across neuroscience, molecular biology, immunology, biological engineering, rehabilitation sciences, and more.

PolyU is the only local university that offers a one-stop solution from treatment to rehabilitation. It has been nurturing numerous allied health professionals such as physical therapists and occupational therapists who work with medical teams to provide extended care through rehabilitation and the application of technology-assisted diagnosis.

With the ATP Laboratory concentrating on advanced therapy and RS providing physiotherapy and other relevant allied health services, patients will be able to receive comprehensive care. During spinal cord injury treatment, for instance, the injured tissue of the patients can be repaired by stem cell transplantation, and their muscle strength and mobility can be retrained through a rehabilitation programme.

Prof. Larry Chow said, “There is significant potential for growth in the production of advanced therapy products in Hong Kong nowadays. The ATP Laboratory at PolyU aligns with the international good manufacturing practices, and will contribute to nurturing more biopharmaceutical talents in the region. Through collaboration with industry partners, we aim to achieve breakthroughs in cell therapy and immunotherapy, translating the research outcomes of the University by facilitating cutting-edge medical research and clinical trials, thereby advancing Hong Kong’s medical technology development.”

PolyU has submitted a proposal to the HKSAR Government for the establishment of the third medical school in Hong Kong. Capitalising on its research strengths in health technologies, engineering and artificial intelligence, as well as its experience in training allied health professionals over the past half-century, the University is confident in its ability to nurture interdisciplinary medical leaders and foster the development of Hong Kong into an international health and medical innovation hub.

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香港理工大學（理大）推進醫學與健康領域的教研發展，以頂尖設施及跨學科優勢，推動精準醫療與個人化治療，助力香港發展為國際醫療創新樞紐。

理大將以先進療法製品（ATPs）建立精準和個人化醫療，促進醫學創新及跨學科合作，推動本地ATPs生態圈，提升香港在全球生物醫學的競爭力。大學現時計劃生產針對脊髓損傷的細胞治療製品，以先進療法結合理大康復治療科學系的專業知識，提供從精準醫療到康復的一站式復康方案，為全身或半身癱瘓患者帶來新希望。

理大擁有符合國際醫藥品稽查協約組織良好生產規範（PIC/S GMP）的ATP實驗室，專注於免疫療法、細胞治療、基因療法及再生醫學臨床研究。理大應用生物及化學科技學系系主任周銘祥教授領導的團隊計劃與業界合作，待實驗室取得由衞生署發出的製造商牌照及臨床證驗及藥物測試證明書後，正式啟動臨床研究。

脊髓損傷的醫療需求

脊髓是中樞神經系統的關鍵組成部分，一旦因意外或疾病受損，可導致受傷部位及以下的神經功能喪失。根據世界衛生組織，全球目前有超過1,500萬人患有脊髓損傷，常見症狀包括四肢或下肢癱瘓、感覺喪失、膀胱及腸道功能障礙、慢性疼痛及運動功能受限，嚴重影響患者的身心健康及生活質素。

目前，脊髓神經損傷尚無有效治癒方法，近年醫學界積極探索精準醫療技術，包括幹細胞治療、基因治療、生物材料與組織工程及電刺激治療等，致力修復受損脊髓。然而，研究顯示單靠先進療法不足以讓患者完全恢復行動能力，必須結合物理治療等專職醫療，進行跨專業復康訓練，才能顯著提升治療效果。

理大ATP實驗室：精準醫療先驅

理大ATP實驗室獲大學教育資助委員會及大學撥款籌建，設生產區、品質管制實驗室及培訓實驗室，待衞生署批准後，將成為本地先進療法製品研發及臨床應用的重要平台，並與科研企業、生物製藥業界及學術機構合作，首階段聚焦為慢性脊髓損傷患者提供臨床測試服務。團隊將利用經人類白細胞抗原（HLA）配對的臍帶血，生產臍帶血單核細胞，進行品質測試及包裝，根據PIC/S GMP規範放行成品並轉交至醫院治療團隊作臨床使用，為患者進行手術移植。這將帶動大學針對神經系統疾病治療的研究合作，發揮理大的跨學科優勢，包括神經科學、分子生物學、免疫學、生物工程及康復治療等學科的合作。

跨學科整合：以病人為中心的護理

理大是本港唯一能夠提供從治療到復康一站式解決方案的大學，其培訓的物理治療師和職業治療師等專職醫療人員，能與醫護團隊合作，透過復康、輔助診斷及科技應用，提供延續護理。理大ATP實驗室專注於細胞治療等精準醫療技術，康復治療科學系則提供物理治療等專職醫療訓練，兩者結合確保患者獲得全面護理。例如，在脊髓損傷治療中，幹細胞移植可修復受損組織，隨後由物理治療師設計個人化復康計劃，幫助患者重新訓練肌肉、增強力量並恢復行動能力。

周銘祥教授表示：「現時香港在生產先進療法製品方面仍然具發展空間，理大ATP實驗室符合國際的良好生產規範，為香港培育更多生物製藥專業人才。我們希望在與業界合作下，能夠於細胞治療和免疫治療上尋求突破，協助轉化大學研究成果並進行臨床測試及前沿臨床醫學研究，提昇香港整體醫療科技研究水平。」

理大早前就籌建香港第三所醫學院向政府提交建議書，有信心憑藉在醫療科技、工程及人工智能方面的雄厚科研實力，以及累積半世紀培養專職醫療人員的豐富經驗，培養跨學科醫療領袖，助力香港發展成為國際醫療創新樞紐。