PROCESSING CRYOPRESERVED HUMAN SPERM

描述(从申请人的描述中扫描)：冷冻保存的人 精子对于重要的治疗是必不可少的。有了标准的程序， 许多/大多数患者的样本解冻后质量(捐赠者高度 选择)是不可接受的，40%的精子受损，怀孕 利率很低。改善结果的生物学是可用的，但由于 使知识适应临床实用方法的努力有限 布景。该项目的重点是这一目标，并将使用容器与 “门孔”面和“快速冷冻保护剂去除装置”(RCRD)，以 消除解冻后因精子快速移动而对人类精子造成的损害 水进入细胞。它们的使用使精子可以在 密封容器，并在解冻后打开门控孔，并以安全的速率 对于精子，用适合于以下条件的缓冲液替换冷冻延长器 宫腔内人工授精(IUI)，对组织无刺激--自动 安全(对于精子和操作员)，不会稀释或取出精子 容器，直到iUI。第一阶段论证了可行性。第二阶段目标 是：(1)改进CryoCell容器和RCRD以满足以下要求的标准 临床试验和优化解冻速度；(2)与新的结果进行比较 技术和标准程序；以及(3)发展和验证程序 适用于临床试验。 建议的商业应用：不可用

DESCRIPTION (Scanned from the applicant's description): Cryopreserved human sperm are essential for important therapies. With standard procedures, post-thaw quality of samples from many/most patients (donors are highly selected) is unacceptable, 40 percent of the sperm are damaged, and pregnancy rate is low. Biology to improve outcome is available, but unused because of limited efforts to adapt knowledge to an approach practical in a clinical setting. This project is focused on that goal and will use containers with "gated-pore" faces and a "rapid cryoprotectant removal device" (RCRD) to eliminate post-thaw damage to human sperm resulting from rapid movement of water into the cells. Their use allows cryopreservation of sperm within a sealed container, and post-thaw opening of the gated pores and, at a rate safe for the sperm, replacement of cryo-extender with a buffer appropriate for intrauterine insemination (IUI) and not irritating to tissues--automatically and safely (for sperm and operator) without dilution or removal of sperm from the container until IUI. Phase-I demonstrated feasibility. Phase-II objectives are: (1) refine the CryoCell container and RCRD to meet standards needed for clinical trials and optimize thaw rate; (2) compare results with the new technology and standard procedures; and (3) evolve and validate procedures appropriate for clinical trials. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE