Commercialization of Human Mammary Basal / Luminal Cell System for Research

人类乳腺基底/腔细胞系统的商业化研究

• 批准号: 8000878
• 负责人: BENJAMIN M BUEHRER
• 金额: $ 68.19万
• 依托单位: ZEN-BIO, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8000878
• 关键词: Address; Basal Cell; Biological Assay; Biological Models; Breast; Cells; Coculture Techniques; Communities; Contracts; Development; Diagnosis; Drug Formulations; Ductal Epithelial Cell; Epithelial Cells; Etiology; Funding; GRB7 gene; Gene Dosage; Gene Expression; Gland; Goals; Growth Factor; Hormones; Human; In Vitro; Individual; Lobular; Maintenance; Malignant - descriptor; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary Neoplasms; Mammary gland; Milk; Modeling; Myoepithelial cell; Normal Cell; Pattern; Phase; Phenotype; Population; Preparation; Procedures; Process; Protocols documentation; Quality Control; Reagent; Research; Research Personnel; Research Support; Serum; Services; Source; Structure; System; Time; Tissues; Toxic effect; Tumor Tissue; Tumor-Derived; Variant; Woman; anticancer research; base; cell population study; cell type; commercialization; comparative; controlled release; cost; human tissue; keratin 5; malignant breast neoplasm; phase 1 study; public health relevance; receptor; response; systems research; tool; tumor

DESCRIPTION (provided by applicant): Breast cancer is the second most common cancer among women. Roughly 190,000 women in the U.S. will be diagnosed with breast cancer in 2009, and 40,000 will die. The majority of breast cancers originate in the lobular or ductal cells of the milk-producing glands. In these structures, there are two main cell types: the inner luminal cells surrounded by basal myoepithelium. These cells types are distinct and are the precursors to various forms of breast cancer. As such, it is it is important to study these cell populations independently as well as in co-culture models systems. There are no commercial sources of quality-controlled, matched basal and luminal cells (from individual donors), forcing researchers to isolate and characterize the cells on their own. This process is time-consuming, requires access to human tissue, and introduces variation in the preparation and characterization of the cells. Primary cultured human mammary-derived cells are an ideal model currently used to investigate the genesis and understanding of human breast cancer. Because a consistent commercial source of primary human cultured breast-derived luminal and basal cells is unavailable, Zen-Bio, Inc. will address this need by providing a well characterized system to the research community. Phase I of this project focused on generating an optimized primary human mammary-derived basal/luminal cell system from non-diseased tissue. Isolation and propagation of normal human basal and luminal mammary epithelial cells was achieved. Based on the successful completion of Phase I, we are eager to extend our research in Phase II by focusing on making this cell system commercially available. Additionally, we will expand the cell system to include basal and luminal mammary epithelial cells from breast tumor tissue. Aim 1 of this project is to continue detailed characterization of normal basal and luminal cells focusing on quality control and release criteria for commercialization. Aim 2 is to establish isolation and propagation procedures and detailed characterization of human breast cancer tumor derived cells building on our existing capabilities. Aim 3 is to perform comparative analyses between normal and malignant human cells to establish quality control criteria for commercialization and additional contract assay services at Zen-Bio. Multiple product offerings are expected from this proposal: matched, primary human mammary cell systems from non- diseased and malignant tissue, support media and reagents, contract assay services, and kits for breast cancer research. PUBLIC HEALTH RELEVANCE: At the completion of this project, a fully characterized human primary mammary-derived basal/luminal cell system from normal and malignant breast tissue will be commercially available to researchers. These systems will provide a currently unavailable opportunity to investigate the etiology of breast cancer and to identify potential cures.

描述（由申请人提供）：乳腺癌是女性中第二常见的癌症。 2009年，美国大约有19万名妇女将被诊断出患有乳腺癌，而40,000名将死亡。大多数乳腺癌起源于产牛奶的腺体的小叶或导管细胞。在这些结构中，有两种主要的细胞类型：内腔细胞被基底肌上皮包围。这些细胞类型是不同的，是各种形式的乳腺癌的前体。因此，重要的是独立研究这些细胞种群以及共培养模型系统。没有商业来源的质量控制，匹配的基础和腔细胞（来自个别捐助者），迫使研究人员独自分离和表征细胞。这个过程耗时，需要进入人体组织，并引入细胞的制备和表征变化。原发性培养的人类乳腺衍生细胞是目前用于研究人类乳腺癌的起源和理解的理想模型。由于不可用的原代人培养的乳腺腔和基底细胞的一致商业来源，因此Zen-Bio，Inc。将通过为研究界提供良好的系统来满足这一需求。 该项目的第一阶段着重于从非脱落组织产生优化的原代人乳腺衍生的基底/腔细胞系统。实现了正常人基底和腔内乳腺上皮细胞的分离和传播。基于第一阶段的成功完成，我们渴望通过专注于使该细胞系统在市售中提供的研究来扩展第二阶段的研究。此外，我们将扩展细胞系统，包括乳腺肿瘤组织中的基础和腔内乳腺上皮细胞。该项目的目的1是继续详细描述正常基础和腔内细胞，这些基础和腔内细胞关注质量控制和释放商业化标准。目的2是建立隔离和传播程序，并根据我们现有能力建立的人类乳腺癌肿瘤衍生细胞的详细表征。 AIM 3是在正常和恶性的人类细胞之间进行比较分析，以在Zen-Bio建立用于商业化和其他合同测定服务的质量控制标准。该提案预计会产生多种产品：与未患病组织和恶性组织，支持媒体和试剂，合同测定服务以及用于乳腺癌研究的试剂盒的匹配的原发性人类乳腺细胞系统。 公共卫生相关性：在该项目完成后，研究人员将在正常和恶性乳腺组织中获得完全特征的人类原发性乳腺衍生的基底/腔细胞系统。这些系统将提供当前无法使用的机会来研究乳腺癌的病因并鉴定潜在的治疗方法。