Intervertebral Disc Degeneration

Public symposium by NUSI marks the end of a series of spine-related events that provide doctors with platform for professional development and networking SINGAPORE, March 30, 2024 /PRNewswire/ -- The National University Spine Institute (NUSI) is a new dedicated specialist spine institute under the National University Health System (NUHS) that provides multidisciplinary care for patients with spinal diseases and deformities. With an experienced team of spine specialists backed by medical best practices, methodologies and technology, NUSI is steadfast in its commitment to adapting to the evolving healthcare landscape, including addressing the rapid increase in complex spine healthcare for both non-operative and operative demands in an ageing population in Singapore. Under the leadership of Associate Professor Gabriel Liu, NUSI aims to set new standards in spine care through a patient-centric approach. A/Prof Liu said: "NUSI differentiates itself by providing dedicated sub-specialties within the spine practice, standardising work processes and providing value-driven patient care across the cluster to address spinal problems. NUSI is dedicated to developing community care programmes for patients, with cases expected to rise in the coming years partly due to an ageing population." The ageing demographic in Singapore is a pressing concern, with the nation set to attain "super-aged" status in 2026. By 2030, one in four persons in Singapore will be aged 65 and above, up from one in six now. This shift puts a spotlight on age-related spine conditions such as scoliosis, spinal stenosis and degenerative disc disease. With about 1,000 magnetic resonance imaging (MRI) scans ordered at the National University Hospital (NUH) a month, a new deep learning model known as SpineAI is helping radiologists identify spinal abnormalities more efficiently. This application of artificial intelligence (AI) was shared by Dr Jonathan Tan, Consultant in NUSI as well as the Department of Orthopaedic Surgery at NUH, at the inaugural NUSI Fellows Best Practice and Research Conference on 20 March, which saw attendance from local and international spine specialists who convened to share best practices and research presentations on cutting-edge surgical techniques. This event highlights NUSI's commitment to knowledge sharing and global collaboration. The international doctors in attendance are also NUSI spine fellows, who have passed through the doors of NUH to gain exposure to Singapore's healthcare industry and hone their skills in their specialties through the hospital's clinical fellowship scheme. The NUSI Spine Fellow Chapter is part of the NUH Global Fellows Alliance, which boosts more than 900 clinical fellows. Some 35 local and international doctors also attended the NUSI Advanced Cervical Spine Surgery Cadaveric Course on 21 March, which took them through the management of complex cervical spine conditions via lectures and discussions, hands-on cadaveric dissections and live surgery demonstrations. These spine-related events will culminate in the first NUSI Public Spine Symposium to be held at NUHS on 30 March, which features free talks by NUSI doctors on a range of spinal conditions from slipped disc to spine cancer. Attendees will also get to learn exercises to strengthen the back, undergo free scoliosis and osteoporosis screening and hear from members of Scoliosis Support Singapore about what it is like living with and overcoming scoliosis. A/Prof Liu said: "NUSI is not just about transforming spine care. We want to empower individuals with the knowledge and resources they need for better spine health. Through our comprehensive public engagement initiatives and community outreach, we hope to foster awareness, education and prevention that will better improve spine health among the community." NUSI has a multidisciplinary approach that involves orthopaedic spine surgeons, neurosurgeons and rehabilitation clinicians across NUHS, to provide a seamless patient experience across the full spectrum of spine care, from pain management to rehabilitation medicine, and the latest in minimally invasive, navigation, robotic spine surgery as well as complex surgical techniques for the treatment of scoliosis, spinal tumours, degenerative spine disorders and spinal trauma. About the National University Health System (NUHS) ­­The National University Health System (NUHS) aims to transform how illness is prevented and managed by discovering causes of disease, development of more effective treatments through collaborative multidisciplinary research and clinical trials, and creation of better technologies and care delivery systems in partnership with others who share the same values and vision. Institutions in the NUHS Group include the National University Hospital, Ng Teng Fong General Hospital, Jurong Community Hospital and Alexandra Hospital; three National Specialty Centres – National University Cancer Institute, Singapore (NCIS), National University Heart Centre, Singapore (NUHCS) and National University Centre for Oral Health, Singapore (NUCOHS); the National University Polyclinics (NUP); Jurong Medical Centre; and three NUS health sciences schools – NUS Yong Loo Lin School of Medicine (including the Alice Lee Centre for Nursing Studies), NUS Faculty of Dentistry and NUS Saw Swee Hock School of Public Health. With member institutions under a common governance structure, NUHS creates synergies for the advancement of health by integrating patient care, health science education and biomedical research. As a Regional Health System, NUHS works closely with health and social care partners across Singapore to develop and implement programmes that contribute to a healthy and engaged population in the Western part of Singapore. For more information, please visit . SOURCE National University Health System (NUHS)

2024年1月31日，FibroBiologics以Direct Listing（直接上市）的方式上市。公司不发行新股，不从上市中获得任何融资。FibroBiologics曾在美国最大的股权众筹平台之一startengine创下历史上增长最快的生物技术公司纪录，筹集金额超100万美元。FibroBiologics总部位于得克萨斯州，在2021年从FibroGenesis中分拆出来，是一家基于成纤维细胞的细胞疗法公司。目前，公司药物管线还未推进至商业化进程，因此未有盈利，2023年净亏损1648.5万美元。但据FibroBiologics财报数据，公司的现有资本至少能为2025年2月28日之前的运营提供资金。 2023和2022年财务报表（图源：FibroBiologics官网）押注成纤维细胞，已获和待批专利超250项英国科学家约翰·格登和日本科学家山中伸弥因发现成熟细胞可以被重新编程为多功能的干细胞iPS（即诱导多功能干细胞）而获2012年诺贝尔生理学或医学奖，此后围绕干细胞的实验和研究便不断增多。实验室中的突破性进展促成了干细胞的首次人体试验，公司创始人Pete O'Heeron遂将目光转向与间充质干细胞一样具有多向分化潜能的成纤维细胞，并开始围绕这一“新”细胞进行研究。Pete具有扎实的医疗与管理学术基础，他在德克萨斯州立大学获得医疗保健管理学士学位，在休斯顿清湖大学获得医疗保健管理硕士学位，并在芝加哥大学获得兼并与收购高级管理证书。在医疗技术和生物技术开发领域，Pete“摸爬滚打”超25年，拥有300多项已获专利和待批专利。据FibroBiologics官网，在创立FibroBiologics之前，Pete曾创办一家名为Advanced Medical Technologies的业务投资集团，投资医疗治疗领域具有潜力的早期项目。此外，他还创立过医疗器械系统开发公司NeoSurg Technologies（2006年出售给Cooper Surgical）。正是这些经历，促使他在生物制剂、先进手术器械和医疗战略咨询等方面都具有个人独到的见解，并能将其融入公司的战略布局和管理之中。他广集人才，和团队一起不断推动独有技术和产品的商业化进程，公司目前拥有250多项已获和待批专利。Pete O'Heeron（图源：FibroBiologics官网）成纤维细胞：干细胞的挑战者，易获取、易分离、易培养人体内只有两种细胞类型可以再生组织和器官，那便是干细胞和成纤维细胞。成纤维细胞数量大大超过干细胞，而且没有干细胞在来源、分离和培养方面的限制，似乎是更好的细胞来源。成纤维细胞是结缔组织的主要细胞类型，可以产生并维持细胞外基质，保证组织和器官结构的完整性。除了在伤口愈合的组织重塑和增殖阶段使细胞外基质沉积外，还在免疫调节中发挥重要作用。 成纤维细胞示意图（图源：FibroBiologics官网）具体而言，成纤维细胞较干细胞而言的优势在于：● 易获取手术中产生的多余组织可作为异源成纤维细胞的主要来源，患者的一次皮肤穿孔就能为大多数临床应用提供充足的自体成纤维细胞来源。● 易分离成纤维细胞的平均倍增时间（16-24小时）明显更短，而且可稳定传代15次，因此从组织中分离成纤维细胞更简单直接。● 易培养成纤维细胞的扩增和维持对培养基的要求没有干细胞严格。成纤维细胞不需要干细胞所需的高成本添加剂，这就降低了批量生产高质量和稳定成纤维细胞的复杂性和成本。据FibroBiologics官网，在应用方面，成纤维细胞的再生和免疫调节功能甚至比干细胞更有效和强大。成纤维细胞更容易分化成多种不同类型的细胞，包括软骨细胞、脂肪细胞、心肌细胞、肝细胞、骨细胞、上皮细胞和内皮细胞，是临床组织再生应用的理想候选细胞。此外，成纤维细胞更易于维护，在冷链运输物流中不易受损，是干细胞的经济实用的替代品。 干细胞和成纤维细胞对比图（图源：FibroBiologics官网）三条管线同时推进，最快已进入临床1/2期随着FibroBiologics的临床工作进入人体试验阶段，研究人员在大量实验中发现，成纤维细胞参与人体许多生物过程，在治疗领域极具潜力。FibroBiologics专有的成纤维细胞平台是开发治疗慢性疾病（包括退化性椎间盘疾病、多发性硬化症、伤口愈合、癌症）的生物疗法和抗衰老延寿应用（如胸腺内陷逆转和脾脏内陷逆转）的基础。FibroBiologics目前有三款在研管线，进展较快的包括CYMS101和CybroCell™。目前，CYMS101已处于1/2期临床研究阶段，CybroCell™已完成临床前试验，正在提交IND。 药物管线图（图源：FibroBiologics官网）● CYMS101：针对多发性硬化症（MS）MS是一种由T细胞介导的针对髓鞘的自身免疫性疾病。针对MS，FDA目前已经批准了奥瑞珠单抗（Ocrelizumab）、阿仑单抗（Alemtuzumab）、Teriflunomide(Aubagio)等。这些药物可以降低MS的复发率、减轻复发的症状严重程度以及延缓其进展，但具有一定的副作用。目前，仍然未出现无副作用或副作用极小的药物获批。目前，用于自身免疫病治疗主要包含三类细胞：间充质干细胞（MSCs）、调节性T细胞（Treg）、髓源性抑制细胞（MDSCs），利用成纤维细胞的少之又少，而CYMS101就是少数用于治疗MS的异体成纤维细胞疗法。为了解成纤维细胞治疗MS的潜力，FibroBiologics在实验性自身免疫性脑脊髓炎（EAE）多发性硬化症动物模型中对耐受性成纤维细胞进行了体外和体内临床前研究。研究结果表明，耐受性成纤维细胞可以抑制致病性T细胞活化，刺激T调节（Treg）细胞扩增，抑制树突状细胞（DC）成熟，刺激少突胶质细胞扩增和髓鞘蛋白表达。在MS的EAE模型中，使用成纤维细胞的疾病抑制效果明显优于脂肪或骨髓间充质干细胞。此外，与脂肪和骨髓间充质干细胞相比，耐受性成纤维细胞的免疫调节功能也更加强大。在使用CYMS101完成动物实验后，FibroBiologics获批在墨西哥使用成纤维细胞成分对多发性硬化症患者进行临床研究，现已完成第一阶段研究。该研究在五名参与者中进行，研究的主要目标是评估安全性，次要目标是评估疗效，进而确定成纤维细胞在少突胶质细胞扩增中的作用模式。FibroBiologics预计提交2期临床试验的IND申请，并表示可能会寻求战略伙伴，合作开发CYMS101的3期临床试验。● CybroCell™：针对椎间盘退行性病变（DDD）DDD又称椎间盘（IVD）退化，是一种与脊柱中一个或多个椎间盘进行性和不可逆退化有关的疾病，大多数患者会出现慢性下背痛的病症。目前，通常利用间充质干细胞（MSCs）治疗DDD。而FibroBiologics打破了常规的治疗方法，采用CybroCell™——一种基于成纤维细胞的通用供体细胞产品。FibroBiologics已在DDD临床前模型中证明了其安全性和有效性，并获得美国食品药品监督管理局的IND批准，在获得其主细胞库批准的情况下，可以在美国进行CybroCell治疗退行性椎间盘疾病的1/2期研究。除上述管线外，FibroBiologics还正处于开发CYWC628（基于异体成纤维细胞的伤口愈合疗法）的临床前研究阶段。其研究重点在于利用成纤维细胞和成纤维细胞衍生细胞来治疗糖尿病小鼠和大鼠的伤口，预计最早于2024年向美国食品及药物管理局（FDA）提交伤口愈合IND申请。在“银发”时代放抗衰老“长线”，国内集中于干细胞技术路线此外，FibroBiologics还具有处于早期研发阶段的抗衰老和治疗肿瘤的项目。 早期研发阶段药物管线图（图源：FibroBiologics官网）随着年龄的增长，胸腺的功能会下降，这一过程被称为胸腺内陷。胸腺内陷过程会促进调节性T细胞（Treg）的生成，从而导致对病原体感染、肿瘤和自身免疫性疾病的易感性增加[1]。而CYTER915利用胸腺成纤维细胞与胸腺其他细胞的相互作用促使胸腺内陷逆转，恢复胸腺功能，进而抑制衰老对免疫系统的影响。通过细胞疗法，可以改善和延长胸腺的寿命，达到抗衰老的目标。今年1月，国家统计局发布数据显示，2023年末中国60岁及以上人口超2.9亿人。国家卫健委预计2035年左右，60岁及以上老年人口将突破4亿，在总人口中的占比将超过30%，进入重度老龄化阶段。有需求就有市场空间，根据艾媒咨询发布的《2022—2023年全球与中国抗衰老行业发展及消费者需求研究报告》，预测到2025年时，全球抗衰老市场规模将突破3000亿美元。在细胞治疗领域，布局成纤维细胞的企业较少，更多还是集中在干细胞。《“十四五”生物经济发展规划》中也提到，要发展基因诊疗、干细胞治疗、免疫细胞治疗等新技术，对开展临床应用的干细胞治疗、细胞免疫治疗、医疗新技术科学开展临床评价等。在动脉橙不完全统计的临床管线中，过半的管线集中于头部企业中，主要集中在肌肉骨骼疾病和血液系统疾病治疗。目前，全球范围内从事干细胞治疗研发的头部代表企业有Athersys、Mesoblast、Gamida Cell、Cynata等。其中Cardio3、BrainStorm Cell Therapeutics和Cynata的几款自研产品都已进入临床三期阶段，获批上市在即。2023年4月，FDA批准Gamida Cell公司的细胞疗法Omisirge（omidubicel）上市。同时，以辉瑞、武田、拜尔等为代表的知名跨国企业陆续通过并购、合作、授权引进等多种交易形式布局该赛道。反观国内，干细胞治疗发展起步较晚，上市公司寥寥。 中国干细胞疗法上市公司图谱（图源：动脉橙数据库）衰老固然难以避免，但可以降速；慢性病难以根治，但也可以延缓其发展进程。与干细胞同样具有分化潜能的成纤维细胞或将代表细胞疗法成为最有潜力治疗慢性疾病的“良方”和抗衰老延寿应用的下一个“风口”。* 参考文献：[1]Wang, W., et al., Thymic Function Associated With Cancer Development, Relapse, and Antitumor Immunity – A Mini-Review. Front Immunol, 2020. 11: p. 773.近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

MELVILLE, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced its participation in the 36th Annual ROTH Conference being held March 17-19, 2024 at the Ritz Carlton, Laguna Niguel in Dana Point, California BioRestorative’s Chief Executive Officer, Lance Alstodt, is scheduled to participate in a fireside chat hosted by Jonathan Aschoff, Ph.D., Managing Director, Senior Research Analyst at ROTH MKM, on Monday, March 18, 2024 at 12:00pm PDT. The fireside chat will be broadcast live and archived on the investor section of the Company’s website at . Mr. Aschoff and other members of the Company’s management team will also participate in a series of one-on-one meetings with investors during the conference. To arrange a meeting with BioRestorative, attending investors are encouraged to contact thier ROTH MKM sales representative or email oneononerequests@roth.com. About BioRestorative Therapies, Inc. BioRestorative Therapies, Inc. ( ) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. • Metabolic Program (ThermoStem®): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements. CONTACT: Email: ir@biorestorative.com