Comparative study of the immediate effect of meridian balance method and electro-acupuncture and electro-acupuncture for chronic lower back pain individuals-a randomized control trail - Balance acupuncture;Electro acupuncture;Back pain ;Acubalm

开始日期2025-04-10

申办/合作机构-

DRKS00031819 / SuspendedN/A

Sponsor-initiated, prospective, monocentric, non-interventional clinical observational study (AWB) to evaluate the Transmaxx® ALIF Cage in spine surgery use according to the intended purpose. - PMCF Transmaxx system

开始日期2024-12-31

申办/合作机构-

NCT05729022 / Not yet recruitingN/AIIT

Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections: A Randomized Controlled Trial

The purpose of this study is to compare the Microendoscopic combined with ultrasound technique to the standard routinely used X-ray guided transforaminal steroid injection technique.

开始日期2024-12-01

申办/合作机构

American University of Beirut Medical Center

[+1]

100 项与椎间盘疾病相关的临床结果

登录后查看更多信息

100 项与椎间盘疾病相关的转化医学

登录后查看更多信息

0 项与椎间盘疾病相关的专利（医药）

登录后查看更多信息

3,077

项与椎间盘疾病相关的文献（医药）

2025-01-01·Biofabrication

Calcium phosphate complex of recombinant human thrombomodulin promote bone formation in interbody fusion

Article

作者: Chen, Yu-Wei ; Wu, Hua-Lin ; Kuo, Cheng-Hsiang ; Lin, Cheng-Li ; Tsai, Jui-Chen ; Tu, Ting-Yuan ; Shyong, Yan-Jye

AbstractInterbody fusion is an orthopedic surgical procedure to connect two adjacent vertebrae in patients suffering from spinal disc disease. The combination of synthetic bone grafts with protein-based drugs is an intriguing approach to stimulate interbody bone growth, specifically in patients exhibiting restricted bone progression. Recombinant human thrombomodulin (rhTM), a novel protein drug characterized by its superior stability and potency, shows promise in enhancing bone formation. A composite bone graft, termed CaP-rhTM, has been synthesized, combining calcium phosphate (CaP) microparticles as a delivery vehicle for rhTM to facilitate interbody fusion. In vitro studies have demonstrated that rhTM significantly promotes the proliferation and maturation of preosteoblasts at nanogram dosage, while exerting minimal impact on osteosarcoma cell growth. The expression levels of mature osteoblast markers, including osteocalcin, osteopontin, alkaline phosphatase, and calcium deposition were also enhanced by rhTM. In rat caudal disc model of interbody fusion, CaP-rhTM with 800 ng of drug dosage was implanted along with a polylactic acid cage, to ensure structural stability within the intervertebral space. Microcomputed tomography analyses revealed that from 8 to 24 weeks, CaP-rhTM substantially improves both bone volume and trabecular architecture, in addition to the textural integrity of bony endplate surfaces. Histological examination confirmed the formation of a continuous bone bridge connecting adjacent vertebrae. Furthermore, biomechanical assessment via three-point bending tests indicated an improved bone quality of the fused disc. This study has demostrated that rhTM exhibits considerable potential in promoting osteogenesis. The use of CaP-rhTM has also shown significant improvements in promoting interbody fusion.

2024-10-01·The Spine Journal

Does the gut microbiome influence disc health and disease? The interplay between dysbiosis, pathobionts, and disc inflammation: a pilot study

Article

作者: Tangavel, Chitraa ; Gopalakrishnan, Chellappa ; Nayagam, Sharon Miracle ; Rajasekaran, Shanmuganathan ; Kanna, Rishi Mugesh ; Vasudevan, Gowdaman ; Muthurajan, Raveendran ; Ramachandran, Karthik ; Anand, Sri Vijay ; Shetty, Ajoy Prasad

BACKGROUND CONTEXTGut microbiome alterations resulting in inflammatory responses have been implicated in many distant effects on different organs. However, its influence on disc health is still not fully investigated.PURPOSEOur objective was to document the gut biome in healthy volunteers and patients with disc degeneration and to understand the role of gut dysbiosis on human disc health.STUDY DESIGNExperimental case-control study.PATIENT SAMPLEWe included 40 patients with disc degeneration (DG) and 20 healthy volunteers (HV). HV comprised of age groups 30 to 60 years with no known record of back pain and no clinical comorbidities, with normal MRI. Diseased group (DG) were patients in the same age group undergoing surgery for disc disease (disc herniation-25; discogenic stenosis-15) and without instability (with Modic-20; and non-Modic-20).OUTCOME MEASURESN/A.METHODSWe analyzed 16S V3-V4 rDNA gut metagenome from 20 healthy volunteers (HV) and compared the top signature genera from 40 patients with disc degeneration (DG) across Modic and non-Modic groups. Norgen Stool DNA Kit was used for DNA extraction from ∼200 mg of each faecal sample collected using the Norgen Stool Collection Kit.16S V3-V4 rDNA amplicons were generated with universal bacterial primers 341F and 806R and amplified with Q5 High-Fidelity DNA Polymerase. Libraries were sequenced with 250×2 PE to an average of 0.1 million raw reads per sample (Illumina Novaseq 6000). Demultiplexed raw data was assessed with FastQC, and adapter trimmed reads >Q30 reads were processed in the QIME2 pipeline. Serum C-reactive protein (CRP) was measured by the immunoturbimetry method and Fatty acid-binding protein 5 (FABP5) was measured in albumin-globulin-depleted plasma through global proteome analysis.RESULTSWe observed significant gut dysbiosis between HV and DG and also between the Modic and non-Modic groups. In the Modic group, commensals Bifidobacterium and Ruminococcus were significantly depleted, while pathobionts Streptococcus, Prevotella, and Butryvibrio were enriched. Firmicutes/Bacteroidetes ratio was decreased in DG (Modic-0.62, non-Modic-0.43) compared to HV (0.70). Bacteria-producing beneficial short-chain fatty acids were also depleted in DG. Elevated serum CRP and increased FABP5 were observed in DG.CONCLUSIONThe study revealed gut dysbiosis, an altered Firmicutes/Bacteroidetes ratio, reduced SCFA-producing bacteria, and increased systemic and local inflammation in association with disc disease, especially in Modic changes. The findings have considerable importance for our understanding and prevention of disc degeneration.

2024-10-01·Journal of Orthopaedics

Establishment of intervertebral disc degeneration models; A review of the currently used models

Review

作者: Keskes, Hassib ; Elmounedi, Najah

One of the frequent causes of low back pain is intervertebral disc degeneration (IDD), which is followed by discogenic pain. Some significant risk factors that have been linked to the onset and progression of IDD include age, mechanical imbalance, changes in nutrition and inflammation. According to recent studies, five types of animal models are established for producing IDD: the spontaneous models, the puncture models, the biomechanical models, the chemical models and the hybrid models. These models are crucial in studying and understanding IDD's natural history and identifying potential treatment targets for IDD. In our study, we'll talk about the technical aspects of these models, the time between model establishment and the apparition of observable degradation, and their potential in various research. Each animal model should be compared to the human natural IDD pathogenesis to guide future research efforts in this area. By improving knowledge and appropriate application of various animal models, we seek to raise awareness of this illness and further translational research.

项与椎间盘疾病相关的新闻（医药）

2024-10-03

·BioSpace

BioRestorative Therapies to Participate in the 3rd Annual ROTH Healthcare Opportunities Conference

MELVILLE, N.Y., Oct. 03, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc . (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ), a regenerative medicine innovator focused on stem cell-based therapies and products, today announced that its Chief Executive Officer, Lance Alstodt, will participate in the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024 in New York City. The event will consist of a series of one-on-one investor meetings. To arrange a meeting with BioRestorative, attending investors are encouraged to contact their ROTH MKM sales representative. About BioRestorative Therapies, Inc. BioRestorative ( ) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products: • 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 cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. 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. BADSC secreted exosomes may also impact weight loss. • BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA) approvals in the emerging BioCosmeceuticals space. 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: Stephen Kilmer Investor Relations Direct: (646) 274-3580 Email: skilmer@biorestorative.com

临床2期细胞疗法

2024-09-18

·PRNewswire

SPINE SURGERY MILESTONE: DR. EHSAN JAZINI ACHIEVES LANDMARK 100TH PRODISC® CERVICAL DISC REPLACEMENT SURGERY

RESTON, Va., Sept. 18, 2024 /PRNewswire/ -- Dr. Ehsan Jazini, renowned spine surgeon at VSI (Virginia Spine Institute), has reached a significant milestone, performing his 100th prodisc® cervical disc replacement surgery at HCA Reston Hospital Center. Dr. Jazini is now the fourth surgeon in the United States to achieve this distinction, further establishing his leadership in advanced spine surgery. Continue Reading Dr. Ehsan Jazini celebrates a landmark achievement at VSI (Virginia Spine Institute), receiving the Prodisc Milestone Award for completing 100 successful procedures with the state-of-the-art Cervical Disc Replacement System Spine Surgeon Dr. Ehsan Jazini successfully completes his 100th prodisc surgery, showcasing the modern surgical techniques that make VSI a leader in motion-preserving spine surgery. With this milestone, Dr. Jazini has demonstrated his expertise in providing patients suffering from neck conditions with modern surgical options that alleviate pain and preserve natural neck motion. He has successfully performed over 1,000 cervical artificial disc replacement surgeries, utilizing devices from four leading companies. This advanced procedure provides an effective treatment for conditions such as degenerative disc disease, herniated discs, spondylosis, radiculopathy, and myelopathy, offering patients pain relief while preserving natural neck motion. "Reaching the 100th prodisc surgery milestone is a testament to my commitment to providing the most advanced, motion-preserving solutions in spine care," said Dr. Jazini. "Each procedure is tailored to meet the patient's specific needs, allowing them to regain mobility and live pain-free, active lives. This achievement highlights my dedication to innovation and solidifies my leadership role in modern spine surgery." Dr. Jazini frequently utilizes the prodisc® C SK and prodisc® C Vivo implants in his surgeries, both offer customized solutions designed to match the patient's unique anatomy. The prodisc system features 84 subtypes and size variations, ensuring optimal fit for the specific level of the treated spine. The implant's ball-and-socket mechanism mirrors the technology used in joint replacements, maintaining the physiological range of motion in the cervical spine. For more information on Dr. Jazini's expertise and advanced spine care options at VSI, visit or contact +1 703.709.1114. SOURCE Virginia Spine Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-08-03

·凯莱英药闻

2024年7月国内生物医药投融资汇总

欢迎关注凯莱英药闻 2024年7月，国内共有14家生物医药企业完成融资。在细分赛道上，包括专注于抗体药物开发的洛启生物、宝济药业、英诺迈博；专注于核酸药物研发的溪砾科技、大睿生物、安天圣施医药；专注于细胞药物研发的夏同生物、椎元医学、跃赛生物；专注于疫苗开发的迈科康生物；专注于核药研发的晶核生物；专注于肿瘤药物研发的泽安生物、安邦生技；专注于乙肝药物研发的浩博医药。一抗体药物 1、洛启生物洛启生物成立于2017年10月，是一家致力于纳米抗体创新药物研发的临床阶段公司，已经建立了一体化、系统化、全面化的专业开发平台，是国内唯一具有纳米抗体药物全流程开发能力的公司。公司自主创建了基于纳米抗体的五大核心技术平台：纳米抗体快速筛选平台、毕赤酵母CMC工艺开发平台、吸入式大分子药物研发平台、纳米抗体长效平台和纳米抗体双抗平台，各平台具有独特的技术领先性，并具有明显的行业竞争优势，能够快速从药物活性纳米抗体的发现筛选推进至产业化。 2、宝济药业宝济药业的核心业务是重组蛋白药物和抗体药物的产业化和商业化，目前正在上海宝山区罗店工业园筹建一座符合GMP要求的现代化生物制药的产业化基地，投资总额超过9亿元人民币，拟建成涵盖哺乳动物细胞表达系统和大肠/酵母表达系统的多条原液生产线，包含水针剂、冻干粉针和一次性预灌封的成品制剂生产线。公司开发了一种专有的技术平台，能够快速降解免疫球蛋白G（IgG）。该平台采用全球领先的低预存抗体IgG降解酶，通过静脉给药，仅需1小时就能完全清除血浆和组织中的致病性IgG型免疫球蛋白。其中，Ricefidase是全球领先的新一代IgG降解酶，源于不感染人类的化脓性链球菌的酶，通过公司自主研发设计改构而获得；该药物能够高度特异性地降解IgG的下铰链区，使其失活。I期临床试验已经证明，在给予Ricefidase后的1到2小时，受试者血清和组织中的IgG几乎全部被酶切清除。 3、英诺迈博英诺迈博是一家以组学大数据驱动靶向药物研发及新型精准医疗决策工具开发的公司，基于蛋白质组学技术及PDX/PDO等多种高临床相关度疾病模型库，建立了独具特色的药物研发决策工具平台，利用高临床相关性大数据与AI计算获得的深度生物学知识，推动自研新药管线与IVD产品的高成功率开发。该技术平台可为新药研发多个关键环节提供理性决策数据支持，包括靶点发现、药物作用机制、患者甄选、临床方案设计、临床研究中继/替代终点确定、联合用药开发、临床用药决策依据、药物适应症拓展等。目前，公司拥有多条创新概念的临床前ADC新药管线，包括基于10余年学术积累的独特靶点产品，可发展为first-in-class的产品，使公司具备差异化竞争优势。二核酸药物 1、溪砾科技溪砾科技（“ReviR”）成立于2021年，是一家结合AI技术进行靶向RNA小分子药物研发的生物科技公司，通过借助前沿技术及AI药物研发平台Voyage R进行更有效、安全的靶向RNA疗法研究，以期解决肿瘤及遗传性疾病长期未被满足的临床需求。VoyageR主要包括靶点发现平台和药物发现平台，前者的功能在于帮助实现RNA结构计算与评估、靶点功能预测，后者的重点任务则在于构建化合物库、分子预测、分子生成等。借助VoyageR，公司能够迅速完成RNA靶向小分子库的建设扩充，结合高通量筛选+AI+自动化实验验证干湿闭环，快速得到临床前候选化合物，极大降低成本、缩短研发周期、提高药物研发成功率。目前，公司聚焦神经退行性疾病等遗传性罕见病布局多条自研管线，并在癌症、免疫、代谢等领域开展合作与相应管线研发。 2、大睿生物大睿生物（Rona Therapeutics）是一家全球领先的核酸创新药平台公司，专注于代谢性疾病和中枢神经退行性疾病的治疗。自2021年成立以来，公司始终致力于研发同类最佳的siRNA药物，目前已经取得了多个同类最佳的siRNA治疗药物在临床试验或新药临床研究申请启动阶段的进展，包括用于高胆固醇血症的PCSK9 siRNA和用于混合性高脂血症的APOC3 siRNA。此外，大睿生物还聚焦于中枢神经退行性疾病领域，深入挖掘肝外核酸递送的潜力，成功建立了特有的肝外递送平台，该平台具有强大的敲低效力且长效性显著，可实现长达九个月甚至更长的给药周期。目前，已有多个肝外递送管线产品进入新药临床研究申请准备阶段，旨在治疗一系列复杂疾病，如肌萎缩侧索硬化、阿尔茨海默病等传统药物治疗方式难以奏效的疾病。 3、安天圣施安天圣施医药成立于 2017 年 4 月，系中国首个以RNA剪接和 RNA 编辑为靶标研发反义寡核苷酸（ASO）药物的公司。安天圣施在原有技术基础上优化升级，发明了新一代干预RNA剪接的5D-ASO和新型ASO诱导RNA编辑的ANISPR等以ASO为核心的新药研发技术。目前有多个项目在推进中，其中针对DMD（杜氏肌营养不良症）、SCA3（脊髓小脑性共济失调3型）等疾病的药物研发已取得重要进展。三细胞疗法 1、夏同生物夏同生物成立于2022年7月，是一家专注于神经系统相关干细胞药物研发的科技创新企业。公司在国际上率先证明外源的少突胶质前体细胞（OPC）在体内可形成髓鞘，且建立了商业化人源OPC体外工业级制备技术；同时，独创以PBMC为起始细胞经转录因子及小分子诱导重编程一步生成iNSC的方法，细胞来源丰富不受限制，全过程不涉及胚胎干细胞，无伦理和成瘤风险。公司自主掌握从起始细胞到制剂细胞全部技术和工艺关键环节，产品制备工艺已进展到工业级生产规模。公司计划以OPC治疗髓鞘形成低下性脑白质发育不良和多发性硬化等疾病。 2、椎元医学椎元医学是基于成纤维细胞开发创新细胞疗法的初创企业，开发了同种异体成纤维细胞疗法，为退行性椎间盘疾病患者提供全新的细胞解决方案。公司开发的FibroCell人成纤维细胞注射液是通过诱导退变髓核细胞向纤维细胞转化管理椎间盘退变的细胞药物，相比目前的治疗手段，对早中期椎间盘退变的患者有明确的临床价值。 3、跃赛生物跃赛生物成立于2021年6月，致力于开发新一代基于人多能干细胞技术的细胞治疗药物。公司拥有自主研发的人多能干细胞创新技术平台，包括神经分化技术，SISBAR谱系示踪技术，干细胞基因编辑技术、GMP级别的人iPSCs构建。凭借其拥有自主知识产权的人多能干细胞制备、培养、分化和基因编辑技术平台，研发管线覆盖神经退行性疾病、罕见病及肿瘤等。四疫苗迈科康生物迈科康生物成立于2016年，是一家致力于创新疫苗和新型佐剂研发、生产和商业化于一体的全球生物医药企业。公司专注于创新人用和兽用（含宠物）疫苗的研发、生产和商业化，基于国际领先的新型佐剂、重组蛋白平台及免疫评价平台，搭建了一系列重大创新疫苗品种管线。其中，针对传染性、过敏性疾病及肿瘤领域布局了多样化的产品研发管线，包括多个针对重大传染病的预防性疫苗，以及HPV感染、过敏性疾病、癌症等领域的治疗性疫苗，目前已有2项进入临床试验阶段。五核药晶核生物晶核生物成立于 2021 年，致力于开发下一代靶向放射性核素疗法（TRT）。截至目前，晶核生物已经构建了靶向核药开发的专有技术平台，用于配体筛选、调制偶联因子（J-Linker）和临床转化；通过J-Linker多功能偶联平台，可以有效提高药物在疾病部位的暴露量，并降低其它器官的暴露量，进而为晶核生物在研管线带来更好的治疗效果和更宽的安全窗口。 JH02是公司自主研发的的治疗品种，适应症为治疗前列腺特异性膜抗原（PSMA）阳性的转移性去势抵抗性前列腺癌（mCRPC）成年患者。相较国外同类型产品具有显著优势，包括更高的安全性、更优的治疗效果以及更简单的生产工艺，有望为患者提供全新的药物选择。该药物于2023年7月正式取得CDE默许开展临床研究，成为国内首家在TRT领域管线中美双报获批的企业。六肿瘤药物 1、泽安生物泽安生物成立于2022年2月17日，是一家专注于免疫疗法研发的初创公司。公司以“髓系细胞衔接器”技术平台（Myeloid Engager Platform）为基础的新型免疫疗法，该平台是全球第一款广谱的天然免疫细胞多功能衔接抗体平台。除了自然杀伤（NK）细胞作为效应物外，还可以有效激活巨噬细胞，以提供直接的抗肿瘤和抗免疫抑制细胞杀伤，并促进肿瘤微环境中的炎症 - 间接导致激活适应性免疫和长期记忆。据悉，公司计划今年完成天然免疫衔接多功能抗体平台的临床前验证和首款药物分子的申报临床批件（IND）-enabling工作，明年年初申报IND，并启动首次人体临床研究。 2、安邦生技安邦生技是一家开发精准抗癌药物的临床阶段生物科技公司，其在研管线包括口服EGFR/HER2酪氨酸激酶抑制剂（TKI）ABT-101，目前正在开发用于HER2 exon20基因突变引发的非小细胞肺癌；其次，HDAC抑制剂ABT-301正在开发用于转移型大肠直肠癌，已进入人体临床试验阶段；KRAS G12D抑制剂ABT-202则处于临床前研究阶段。七乙肝药物浩博医药浩博医药是一家面向全球、临床阶段的创新型生物制药公司，致力于变革乙肝治愈疗法、引领寡核苷酸技术创新，凭借自主知识产权的Med-Oligo™ ASO平台和高效靶向递送技术，聚焦变革性 ASO 疗法，应用于病毒性感染、代谢性疾病、遗传性疾病和免疫性疾病等领域，改善患者生活。公司基于自有平台，结合新型偶联技术的靶向递送系统，正在打造多元化的研发管线；其中，AHB-137的临床Ⅰ期疗效和安全性数据展现了很好的功能性治愈潜力。公司将继续以实现慢性乙肝功能性治愈为起点，研发变革性治疗方案拓展至其他疾病，解决尚未被满足的临床需求。参考资料 1、各公司官网 2、猎云网、投资界、动脉网、亿欧网感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

临床1期核酸药物疫苗