ETIB Clinical Research Core

ETIB 临床研究核心

• 批准号: 8938515
• 负责人: Ronald Gress
• 金额: $ 162.09万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8938515
• 关键词: Age; Allogenic; Area; Autoimmune Diseases; Autoimmune Process; Autoimmunity; Basic Science; Biological Response Modifiers; Biology; Blood; Bone Marrow; Bone Marrow Transplantation; Cancer Vaccines; Caring; Cause of Death; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Communicable Diseases; Communities; Consensus; Data Analyses; Data Collection; Dentistry; Dermatology; Discipline; Disease; Doctor of Medicine; Dose; Educational workshop; Enrollment; Evaluation; Exposure to; Extramural Activities; Fellowship; Foundations; Geum; Goals; Guidelines; Gynecology; HIV; Head; Hematology; Hematopoietic Stem Cell Transplantation; Hematopoietic stem cells; Hodgkin Disease; Homologous Transplantation; Human; Immune; Immunity; Immunocompromised Host; Immunology; Immunotherapy; Individual; Infection; Institutes; Interleukin-2; Interleukin-7; International; Investigation; Joints; Laboratories; Leadership; Lymph; Lymphoma; Malignant Neoplasms; Marrow; Measurement; Multiple Myeloma; National Cancer Institute; National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Disease; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Child Health and Human Development; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Hematologic Malignancy; Non-Hodgkin' s Lymphoma; Oncologist; Ophthalmology; Oral Surgical Procedures; Organ Transplantation; Pain; Palliative Care; Pathologic; Patient Care; Patient Recruitments; Patients; Pediatric Oncology; Phase; Physical Medicine; Physiological; Pilot Projects; Policies; Population; Property; Protocols documentation; Pulmonology; Refractory; Regenerative Medicine; Regimen; Rejuvenation; Relapse; Renal carcinoma; Research; Research Activity; Research Infrastructure; Research Personnel; Rheumatology; Scientist; Series; Societies; Source; Stem Cell Research; Stem cell transplant; Support Groups; T-Lymphocyte; Toxic effect; Translational Research; Transplant Recipients; Transplantation; Transplantation Immunology; United States National Institutes of Health; Work; base; cancer site; cancer therapy; career development; chemotherapy; chronic graft versus host disease; clinical care; cytokine; design; disease mechanisms study; graft vs host disease; immunoregulation; interest; leukemia; medical specialties; member; multidisciplinary; novel strategies; oncology; patient population; programs; reconstitution; tool

The Experimental Transplantation and Immunology Branch (ETIB) clinical transplantation program has as goals the cure of cancer through hematopoietic stem cell transplant therapies, conducting outstanding translational research, and providing the highest level of excellence in clinical care. To this end, the Clinical Core of ETIB was developed. The ETIB Clinical Core provides interactions, activities and support across the branch. It represents a collection of individuals each with particular expertise in clinical transplantation and clinical research. While the section functions as a coordinated effort, it is also designed for individual career development and professional advancement for members. Specific aims include developing a supportive infrastructure for the conduct of clinical transplantation trials, establishing consistent clinical policies and practices in the care of transplantation patients in order to achieve excellence in clinical care, and providing and promoting educational opportunities in hematopoietic stem cell transplantation. Dr. Claude Sportes heads the Immunotherapy Unit of the core. Current research activities center on cancer vaccines in the setting of immune reconstitution following dose intensive chemotherapy. He also has interests in modulation of immune reconstitution by cytokines; he headed the trial to introduce IL-7 into formal phase 1 evaluation. This study was designed and executed by Dr. Sportes as a phase I, inter-patient dose escalation study. It sought to characterize the immunobiologic effects of rhIL-7 therapy in humans and, in particular, its potential for immune rejuvenation of T cell sub-populations. Sixteen subjects with non-hematologic cancer refractory to standard therapy were enrolled (National Cancer Institute, protocol 03-C-0152). RhIL-7 was an effective and well tolerated T cell growth factor with immune rejuvenating properties that suggested it would be effective in augmenting immune reactivity in patients with impaired immunity due to physiologic (age), iatrogenic (chemotherapy/ transplantation) or pathologic (HIV) lymphodepletion. Dr. Juan Gea-Banacloche heads the Infectious Disease Unit of the core. Infections are second only to relapse of malignancy as a cause of death after allogeneic transplant. Excellence in the management of infectious diseases is thus of the utmost importance in establishing a successful transplant program. Over the past 8 years, Dr. Gea-Banacloche has provided constant clinical care of the infectious diseases complications of patients registered on the transplant protocols of ETIB. Dr. Gea-Banacloche has been the source of clinical standards for the management of blood and marrow transplants in the Clinical Center. He has been the main architect of an inter-institute collaboration (NCI-NIAID-NHLBI) that has resulted in the NIH Clinical Center Guidelines for Infection Management of Hematopoietic Stem Cell Transplant Recipients. As part of the collaboration between NCI and NIAID, Dr. Gea-Banacloche has been instrumental in creating a fellowship in "Infectious Disease in Immunocompromised Hosts", which will allow candidates with a background in Infectious Diseases, Hematology-Oncology and other disciplines in-depth exposure to the unique patient populations seen at the NIH Clinical Center as well as introduction to clinical or translational research. Dr. Steven Pavletic, M.D., is head of the GVHD and Autoimmunity Unit. The focus of the autoimmunity program is to study disease mechanisms that separate self-destructive autoimmunity from potentially beneficial autoimmune effects relevant to the treatment of cancer. In January 2003, Dr. Pavletic established an ETIB inter-institute cGVHD program to include a multidisciplinary clinic which brings together clinicians and scientists from eight NIH institutes (NCI, NIAID, NHLBI, NIAMS, NEI, NIDDK, NICHD, NIDCR) and the Clinical Center. The cGVHD clinic serves as a foundation for providing better care of patients and to study cGVHD. The clinic involves clinical researchers of various specialties such as hematology-oncology, pediatric oncology, ophthalmology, dermatology, rheumatology, rehabilitation medicine, pain and palliative care, gynecology, pulmonology, dentistry, oral surgery and others. Multiple laboratories are involved in basic science investigations in protocols based in the clinic. Key objectives of this interdisciplinary clinic-based program include developing new and better chronic GVHD assessment tools to standardize disease measurements in clinical trials, studying chronic GVHD biology, and developing new treatments for chronic GVHD. Dr. Pavletic has also organized efforts in cGVHD at other levels: Local leadership with a joint annual NIH/John Hopkins scientific workshop on cGVHD (held in May 2003 and 2004), regional leadership with formation of the Mid-Atlantic cGVHD consortium comprised of bone marrow transplanters and community oncologists in the region, establishment of a cGVHD patient support group with the DC Leukemia Society Chapter, and national/international leadership with formation of a group to formulate NIH consensus criteria for clinical trials in cGVHD. In collaboration with the extramural office at NIAID and national and international colleagues, Dr. Pavletic initiated a series of three expert workshops to explore pilot studies of allogeneic HSCT in patients with severe autoimmune disease. These three workshops were held in March 2005 (Bethesda) Exploring the feasibility of allogeneic transplantation for autoimmune disease; October 2005 (Newport Beach) Determining the best patient populations and October 2006 (Bethesda) Determining best transplant regimens and disease-specific toxicity issues. These works have been extensively cited since then, forming a basis for invigorating and standardizing the field. Dr. Hardy initiated a similar effort in the area of relapse post transplant. This has resulted in an increased interest in developing new approaches for overcoming this barrier to allogeneic hematopoietic stem cell transplantation, and emphasized the importance of maintaining a focus on this area within the field. Relevant cancer sites: Hodgkins Disease/Lymphoma, Non-Hodgkins Lymphoma, Multiple Myeloma, Kidney Cancer. Relevant Research Areas: Stem Cell Research, Biological Response Modifiers, Bone Marrow Transplantation, Autoimmune Disease, Immunology, Hematology/Lymph, Regenerative Medicine, Organ Transplantation Research, Clinical Research.

实验移植和免疫学分支（ETIB）临床移植计划是通过造血干细胞移植疗法治愈癌症的目标，进行了出色的转化研究，并提供了临床护理的最高水平。为此，开发了ETIB的临床核心。 ETIB临床核心提供整个分支机构的相互作用，活动和支持。它代表了每个人的集合，每个人在临床移植和临床研究方面具有特殊的专业知识。尽管该部分是协调的努力，但它还为成员的个人职业发展和专业发展而设计。具体目的包括为进行临床移植试验的进行开发支持基础设施，建立一致的临床政策和实践，以在移植患者的护理中，以实现临床护理方面的卓越，并为血肿干细胞移植提供和促进教育机会。 Claude Sportes博士负责核心的免疫疗法单位。当前的研究活动集中在剂量强化化疗后免疫重建的情况下进行癌症疫苗。他还对细胞因子调节免疫重建的兴趣；他领导试验将IL-7引入正式的第1阶段评估。这项研究是由Sportes博士设计和执行的，作为I期，患者间剂量升级研究。它试图表征RHIL-7治疗对人类的免疫生物学作用，尤其是其免疫复兴T细胞亚群的潜力。招募了16名非血液学癌症对标准疗法难治性的受试者（国家癌症研究所，方案03-C-0152）。 RHIL-7是一种有效且耐受性良好的T细胞生长因子，具有免疫复兴特性，表明它将有效地增强因生理（年龄），医生（化学/疗法/移植）或病理（HIV）或病理（HIV）淋巴结衰弱而受到免疫力受损的患者的免疫反应性。 Juan Gea-Banacloche博士负责核心的传染病单位。感染仅次于同种异体移植后恶性复发作为死亡原因。因此，在传染病管理方面的卓越是在建立成功的移植计划方面至关重要的。在过去的8年中，GEA-Banacloche博士对ETIB移植方案注册的患者的感染性并发症提供了持续的临床护理。 Gea-Banacloche博士一直是临床中心血液和骨髓移植的临床标准的来源。他曾是Intins Intrintituts合作（NCI-NIAID-NHLBI）的主要建筑师，该协作导致了NIH临床中心的造血干细胞移植受者感染管理指南。 As part of the collaboration between NCI and NIAID, Dr. Gea-Banacloche has been instrumental in creating a fellowship in "Infectious Disease in Immunocompromised Hosts", which will allow candidates with a background in Infectious Diseases, Hematology-Oncology and other disciplines in-depth exposure to the unique patient populations seen at the NIH Clinical Center as well as introduction to clinical or translational research.医学博士Steven Pavletic博士是GVHD和自动免疫部门的负责人。自身免疫计划的重点是研究疾病机制，这些疾病机制将自我毁灭性自身免疫与与癌症治疗相关的潜在有益自身免疫性效应分开。 2003年1月，Pavletic博士建立了一项ETIB Intim-Intintute CGVHD计划，其中包括一个多学科诊所，该诊所汇集了来自八个NIH Institutes（NCI，NIAID，NHLBI，NHLBI，NIAMS，NIAMS，NEI，NEI，NEI，NIDK，NIDDK，NIDDK，NICHD，NICHD，NICCR）和诊所中心的临床医生和科学家。 CGVHD诊所是为患者提供更好护理和研究CGVHD的基础。该诊所涉及各种专业的临床研究人员，例如血液肿瘤学，儿科肿瘤学，眼科，皮肤病学，风湿病学，康复医学，疼痛和姑息治疗，妇科学，肺病学，牙科学，口腔外科手术等。多个实验室参与了基于诊所的方案的基础科学调查。该跨学科诊所计划的主要目标包括开发新的，更好的慢性GVHD评估工具，以在临床试验，研究慢性GVHD生物学以及开发新的慢性GVHD治疗方法中标准化疾病测量。 Pavletic博士还在其他层面上组织了CGVHD的努力：与CGVHD的年度NIH/John Hopkins科学研讨会（2003年5月和2004年5月举行），区域领导，由中大西洋中部CGVHD的组成，由骨头移植者和社区构成的地区组成，该地区的人员在骨骼中，该地区是一家CGG，该地区是一家CGG，该地区是一家CGG，该地区是一家CGG，该地区是一家CGG，建立了CGG，该地区的成员是CGVHD。社会分会和国家/国际领导力组成一个小组，以在CGVHD中为临床试验制定NIH共识标准。 Pavletic博士与NIAID以及国家和国际同事的外部办公室合作，开始了一系列三个专家研讨会，以探索患有严重自身免疫性疾病患者的同种异体HSCT试点研究。这三个研讨会于2005年3月（贝塞斯达）举行，探讨了同种异体移植对自身免疫性疾病的可行性； 2005年10月（纽波特海滩）确定最佳患者人群和2006年10月（贝塞斯达）确定最​​佳移植方案和特定疾病的毒性问题。从那以后，这些作品已被广泛引用，为振兴和标准化该领域构成了基础。 Hardy博士在移植后复发领域发起了类似的努力。这引起了人们对开发新方法的兴趣，以克服同种异体造血干细胞移植的这种障碍，并强调保持关注该领域内该领域的重要性。相关癌症部位：霍奇金斯疾病/淋巴瘤，非霍奇金斯淋巴瘤，多发性骨髓瘤，肾癌。相关研究领域：干细胞研究，生物反应修饰剂，骨髓移植，自身免疫性疾病，免疫学，血液学/淋巴，再生医学，器官移植研究，临床研究。