FDA Warns About Stem Cell Claims中英对照.docx

FDA Warns About Stem Cell ClaimsFDA提醒有关干细胞的研究窗体顶端Stem cell therapies offer the potential to treat diseases or conditions for which few treatments exist.干细胞疗法提供了潜在去治疗疾病或条件的方法存在一些Stem cells, sometimes called the bodys “master cells,” are the precursor cells that develop into blood, brain, bones and all of your organs. Their promise in medical treatments is that they have the potential to repair, restore, replace and regenerate cells that could then be used to treat many medical conditions and diseases.干细胞，有时被称为人体的“主人细胞”是最先的细胞发展成血液，大脑，骨头和所有的人体器官。它们在医学治疗方面的保证是它们有潜在的能力去修复，恢复，代替和再生能治疗医学方面的情况和疾病的细胞。But the Food and Drug Administration (FDA) is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.但是食物和药品管理部门（FDA）担心病人对于治好病的希望不会实现，这可能会让他们容易受到不合法的也是有伤害的干细胞治疗。FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.FDA提醒用户确保任何干细胞治疗自己想接受的已被FDA认可或正在被FDA认可并允许诊所的FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the bodys blood-forming system.FDA至今只认可了一个干细胞产品，Hemacord,一个被纽约血液中心制造的脐血产品，用于指定适应症患者疾病影响人体造血系统back to topRegulation of Stem Cells干细胞的控制FDA regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use.FDA控制在美国的干细胞来确保它们对于它们的用处是安全的和有效的“Stem cells can come from many different sources and under the right conditions can give rise to many different cell types,” says Stephanie Simek, Ph.D., deputy director of FDAs Office of Cellular, Tissue and Gene Therapies.“干细胞可以从各种不同的来源得到并且在适当的情况下可以产生许多不同的细胞种类，”Stephanie Simek，一位哲学博士说，FDA细胞，组织和基因管理办公室的副主任Stem cells that come from bone marrow or blood are routinely used in transplant procedures to treat patients with cancer and other disorders of the blood and immune system.从骨髓或血液里来的干细胞经常被用在移植程序来治疗拥有癌症和其他血液免疫系统Umbilical cord blood is collected from a placenta with the birth mothers consent. Cord blood cells are then isolated, processed, and frozen and stored in a cord blood bank for future use. Cord blood is regulated by FDA and cord blood banks must follow regulatory requirements.脐带血是在亲生母亲准许下从胎盘里取出的。脐带血细胞之后是隔离的，再经过加工，然后冷藏并储存在一个脐带血库等将来使用。脐带血是由FDA控制，脐带血存库必须遵守法规要求But there are many other stem cell products, including other cord blood-derived products, that have been reviewed by FDA for use in investigational studies, says Simek. Investigational products undergo a thorough review process as the sponsor prepares to study the safety and effectiveness of the product in adequate and well-controlled human studies (clinical trials).但是还有许多别的干细胞产品，包括其他由脐带血起源的产品，被FDA检验后用在调查研究，Simek说道。研究产品经历一个彻底的审查过程，同时主办者准备在一个良好控制的研究（临床试验）下研究产品的安全性和有效性。As part of this review, the sponsor must show how the product will be manufactured so that FDA can make certain that appropriate steps are being taken to help assure the products safety, purity and potency. FDA also requires that there be sufficient data generated from animal studies to aid in evaluating any potential risks associated with the use of these products.在审查中，举办人应当显示产品如何制造，这样FDA可以确保适当的手段被用来帮助确保产品的安全、纯度和效率。FDA同时也要求动物研究的足够的数据来帮助评估使用这些产品是潜在的风险。Consumers need to be aware that at presentother than cord blood for certain specified indicationsthere are no approved stem cell products.用户需要知道现在，除了某些指定用途的脐带血，没有其它认可的干细胞产品back to top Advice for Consumers给用户的建议 If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal. 如果你在考虑在美国接受干细胞治疗，问你的医生是否被FDA批准了或者如果你是FDA的一个被批准的临床研究对象。如果干细胞是你自己的，这也适用。即使干细胞是你自己的，也要考虑安全风险，包括细胞被移除体外后受到的影响。“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body,” says Simek. Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.“还有一个潜在的风险是当你把细胞放在身体原来的地方但它们不执行相同的生物功能”Simek说道。细胞在不同的环境下可能会增加，形成肿瘤，或者会离开原地迁移到别处。 If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country thatunlike the U.S.may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products. 如果你在考虑在别国拥有一个干细胞治疗，学习所有那个国家对于产品的规章。谨慎在一个国家不像美国可能不会要求临床研究来证明这个产品是安全而有效的，去接受一个拥有干细胞根基的产品治疗。FDA不管理在唯一一个国家用的干细胞治疗，除了美国，通常也只有一点信息关于国外企业或它们的干细胞产品back to topThwarting a Stem Cell Scheme阻止一个干细胞计划In December 2011, three men were arrested in the United States and charged with 15 counts of criminal activity related to manufacturing, selling and using stem cells without FDA sanction or approval.在2011年12月，三人在美国被逮捕并且有15次有关没经过FDA批准或同意生产，卖和使用干细胞的违法活动According to the criminal indictment, one of the accused, a licensed midwife who operated a maternity care clinic in Texas, obtained umbilical cord blood from birth mothers, telling them it was for “research” purposes. Instead, the midwife sold the cord blood to a laboratory in Arizona which, in turn, sent the blood to a paid consultant at a university in South Carolina. The owner of the laboratory in Arizona was convicted in August 2011 of unlawfully introducing stem cells into interstate commerce. She faces up to 3 years in prison and a fine of up to $10,000.根据犯罪起诉书，其中一个被告，一个有执照的接生婆在德克萨斯州经营了一个妇产科医院，从亲生母亲获得了脐带血，告诉她是用在“研究”方面。反而，接生婆却把脐带血卖给了亚利桑那州的一家实验室，在2011年8月被告非法把干细胞介绍给洲际商业。她面对的是在监狱里的3年和达到1万美元的罚款。The consultant, an assistant professor, used university facilities to manufacture stem cell products. He then sent the products back to the lab, which sold them to a man representing himself as a physician licensed in the U.S. The man then traveled to Mexico to perform unapproved stem cell procedures on people suffering from cancer, multiple sclerosis and other autoimmune diseases.这个顾问，一位助理教授，用大学的设备来制造干细胞产品。他然后把这些产品送回了实验室，然后卖给了一个在美国自称得到医学许可证的人。那个人到了墨西哥，在有疾病的人生上执行未批准的干细胞程序。The three defendants allegedly received more than $1.5 million from patients seeking treatment for incurable diseases.三个被告依其申述从给得了不可治愈的疾病的人得到了大于150万.“Scammers like these offer false hope to people with incurable diseases in order to line their own pockets with money,” says Special Agent in Charge Patrick J. Holland of FDAs Office of Criminal Investigations (OCI), Kansas City Field Office. “FDA will continue to aggressively pursue perpetrators who expose the American public to the dangers of unapproved stem cells and ensure that they are punished to the full extent of the law.”“骗子为了钱去给得了不可治愈的病的人们假的希望”一位官员说道，（地址），FDA会继续追查把美国公众揭露于不被批准的干细胞的危险的犯人并确保他们受到法律最大的制裁。FDAs OCI worked the case with the Federal Bureau of Investigations and the Internal Revenue Services Criminal Investigations Division.This article appears on FDAs Consumer Updates page4, which features the latest on all FDA-regulated products.Jan. 6, 2012back to topWhat are stem cells? How are they regulated?Stem cells are cells that have the ability to divide and develop into many different cell types in the body during early life and growth. Stem cells may also help repair the body by dividing to replenish cells that are damaged by disease, injury, or normal wear. When a stem cell divides, each new cell has the potential either to remain a stem cell or to become another type of cell with a more specialized function, such as a nerve cell, a skin cell, or a red blood cell.干细胞是细胞有能力分化和发展成许多不同类型的细胞在体内的早期生活和生长的。干细胞也可帮助修复身体除以补充细胞被破坏的疾病，受伤，或正常磨损。当一个干细胞，每个细胞都有潜在的仍然是一个干细胞或成为另一种类型的细胞以更专业化的功能，如神经细胞，皮肤细胞，或红血细胞。Three types of stem cells have been identified: 1. adult stem cells 成人干细胞2. human embryonic stem cells 人类胚胎干细胞3. induced pluripotent stem cells 多能干细胞These three types of stem cells share properties: They are capable of surviving over long periods and divide to make additional stem cells. 他们能存活长时间并分作更多的干细胞 They are unspecialized (“blank slates” that can become specific types of cells). 他们不是专业的 They can develop into specialized cell types (cells that do specific work in the body). 他们能发展成专业的细胞种类Adult stem cells can be found throughout the body. They are found as unspecialized cells among the specialized cells in tissues and organs as well as in umbilical cord blood and peripheral blood (that is, hematopoietic stem cells). An adult stem cell can either divide to make more adult stem cells, or differentiate to produce some or all of the major specialized cell types of the tissue or organ.成人干细胞能在人体内找到。他们发现特化的细胞和专业细胞的组织和器官同时也在脐带血内和外围血内（那是，造血干细胞）。一个成年干细胞能分割成更多的成年干细胞，或生产更多在组织和器官里的细胞。Human embryonic stem cells (hESC) come from embryos that develop from eggs that have been fertilized in vitro (in a test tube or another artificial environment). Embryonic stem cells can develop into any specialized cell type in the body.人类胚胎干细胞（hESC）来自胚胎的发展从卵已体外受精（试管或其他的人造环境）。胚胎干细胞能发展成任何细胞类型。Induced pluripotent stem cells (iPS) are generated by reprogramming adult cells that have already differentiated into a specific cell, such as a skin cell. After reprogramming, iPS cells are able to develop into any specialized cell type in the body.IPS是由已分化成特定细胞的成年细胞变异来的，就像皮肤细胞。经过变异，IPS细胞能发展成人体中的任何一种细胞Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.干细胞，想其它医药产品用来治疗或预防疾病，通常需要FDA的认可，批准才能上市。至今，还没有被批准的干细胞治疗More Information Consumer Update: FDA Warns About Stem Cell Claims1 Consumer Information on Stem Cells2Consumer Information on Stem CellsConsumer Update: FDA Warns About Stem Cell Claims1Are any stem cell treatments approved in the U.S.?FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications including certain blood cancers and some inherited metabolic and immune system disorders (Press Release: FDA approves first cord blood product2)FDA没有批准任何干细胞产品使用,其他造血祖细胞的情况(血液形成干细胞)对某些迹象包括某些血液癌症和一些遗传性的代谢和免疫系统紊乱What should consumers know before being treated with therapies derived from stem cells?As is the case with any investigational treatment, consumers should speak with their doctor to learn about the potential risks and benefits from being treated with a stem cell-based product. Consumers should seek assurance from their treating physician that necessary FDA approval has been obtained, or that they will be part of a clinical study being conducted in accordance with FDA regulations before proceeding with treatment.就像任何调查处理，消费者应该与他们的医生了解潜在的风险和利益的治疗与干细胞为基础的产品。消费者应寻求保证他们的治疗医生，必要的食品和药物管理局批准了，或者他们是临床研究正在进行针对食品及药物管理局的规定进行前处理。What should consumers know before seeking stem cell treatments outside the U.S.?Consumers should also be aware that in most cases FDA has not reviewed data associated with the products offered in other countries, including stem cell-based products, and can not comment on their safety and effectiveness. It is also important to understand that treatments offered in other countries may not be subject to the sam