45 Part 606—Current Good Man- Ufacturing Practice
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Factors Affecting Mobilization of Peripheral Blood Progenitor Cells in Patients with Lymphoma’
Vol. 4, 311-316, February 1998 Clinical Cancer Research 311 Factors Affecting Mobilization of Peripheral Blood Progenitor Cells in Patients with Lymphoma’ Craig H. Moskowitz,2 Jill R. Glassman, (median, 13 versus 22 days; P 0.06). Patients who received 1l cycles of chemotherapy prior to PBPC mobilization David Wuest, Peter Maslak, Lilian Reich, tended to have delayed platelet recovery to >20,090/&l and Anthony Gucciardo, Nancy Coady-Lyons, to require more platelet transfusions than less extensively Andrew D. Zelenetz, and Stephen D. Nimer pretreated patients (median, 13.5 versus 23.5 days; P 0.15; Division of Hematologic Oncology, Department of Medicine median number of platelet transfusion episodes, 13 versus 9; [C. H. M., D. W., P. M., L. R., A. G., N. C-L., A. D. Z., S. D. N.] and P = 0.17). Department of Biostatistics [J. R. G.], Memorial Sloan-Kettering Cancer Center, New York, New York 10021 These data suggest that current strategies to mobilize PBPCs may be suboptimal in patients who have received either stem cell-toxic chemotherapy or 11 cycles of chem- ABSTRACT otherapy prior to PBPC mobilization. Alternative ap- The objective of this study was to identify factors asso- proaches, such as ex vivo expansion or the use of other ciated with poor mobilization of peripheral blood progenitor growth factors in addition to G-CSE, may improve mobili- cells (PBPCs) or delayed platelet engraftment after high- zation of progenitor cells for PBPC transplantation. dose therapy and autologous stem cell transplantation in patients with lymphoma. INTRODUCTION Fifty-eight patients with Hodgkin’s disease or non- The use of high-dose chemoradiotherapy supported by Hodgkin’s lymphoma underwent PBPC transplantation as cryopreserved autologous hematopoietic progenitor cells is ef- the “best available therapy” at Memorial Sloan-Kettering fective in treating relapsed HD3 and NHL; a high complete Cancer Center (New York, NY) between 1993 and 1995. -
0985.03CC Non-Mobilized Donor Consent
Fred Hutchinson Cancer Research Center Consent to take part in a research study: 985.03CC – Non-Mobilized Donor Consent to Participate as a Donor of Non-Mobilized Peripheral Blood Mononuclear Cells for Laboratory Research and Process Development Studies. Principal Investigator: Derek Stirewalt, MD, Member, FHCRC, (206 667-5386) Investigators: Michael Linenberger, M.D., FACP Professor, Division of Hematology, UW, Robert & Phyllis Henigson Endowed Chair, Program Director, Hematology/Oncology Fellowship Medical Director, Apheresis and Cellular Therapy, SCCA, Member, FHCRC, Associate Professor of Medicine, UW, (206 667-5021); Laura Connelly Smith, Assistant Member, FHCRC, Assistant Professor, UW (206 606 -6938) Research Coordinator: Aubrey McMillan, (206) 667-3539 Emergency Phone (24 hours) UW Transplant unit 8NE: (206) 598-8902 UW Nocturnist on call provider (7:00 PM -7:00 AM): (206) 598-1062 Donor recruitment and participation: 206-667-5318 Important things to know about this study. You are invited to participate in a research study. The purpose of this research is to collect blood cells by a procedure called “leukapheresis”. Leukapheresis is a procedure that allows for a greater collection of peripheral blood cells than can be obtained by standard blood donation. Our purpose is to collect both small blood draws and larger samples of peripheral blood cells for laboratory research studies. This research may involve analysis of your genetic material called DNA and RNA. The studies may also examine other components of the cell like proteins. These analyses can be used to better understand cancer and other diseases. People who agree to join the study will be asked to attend 2 appointments over up to 30 days. -
Leukapheresis Protocol for Nonhuman Primates Weighing Less Than 10 Kg
Journal of the American Association for Laboratory Animal Science Vol 52, No 1 Copyright 2013 January 2013 by the American Association for Laboratory Animal Science Pages 70–77 Leukapheresis Protocol for Nonhuman Primates Weighing Less than 10 Kg Vimukthi Pathiraja, Abraham J Matar, Ashley Gusha, Christene A Huang, and Raimon Duran-Struuck* Leukapheresis is a common procedure for hematopoietic cell transplantation in adults. The main challenge in applying this procedure to human infants and small monkeys is the large extracorporeal blood volume (165 mL on average) necessary for priming the apheresis machine. This volume represents greater than 50% of the total circulating blood volume of a human neonate or small monkey. In this report, we document a safe leukapheresis protocol developed for rhesus macaques (3.9 to 8.7 kg). To avoid sensitizing donor animals undergoing leukapheresis to third-party blood products, autologous blood col- lected during the weeks prior to leukapheresis was used to volume-expand the same donor while priming the machine with saline on the day of leukapheresis. During the procedures, blood pressure was controlled by monitoring the inlet volume, and critical-care support was provided by the anesthesia team. Electrolytes and hemogram parameters were monitored intermit- tently. Overall, our research subjects underwent effective 4- to 6-h leukapheresis. A total of 9 leukapheresis procedures were performed, which yielded 1 × 109 to 6 × 109 peripheral blood mononuclear cells containing 1.1 to 5.1 × 106 CD34+ cells (assessed in 4 of 9 macaques) in a volume of 30 to 85 mL. All macaques showed decreases in Hct and platelet counts. -
Current Challenges in Providing Good Leukapheresis Products for Manufacturing of CAR-T Cells for Patients with Relapsed/Refractory NHL Or ALL
cells Article Current Challenges in Providing Good Leukapheresis Products for Manufacturing of CAR-T Cells for Patients with Relapsed/Refractory NHL or ALL Felix Korell 1,*, Sascha Laier 2, Sandra Sauer 1, Kaya Veelken 1, Hannah Hennemann 1, Maria-Luisa Schubert 1, Tim Sauer 1, Petra Pavel 2, Carsten Mueller-Tidow 1, Peter Dreger 1, Michael Schmitt 1 and Anita Schmitt 1 1 Department of Internal Medicine V, University Hospital Heidelberg, 69120 Heidelberg, Germany; [email protected] (S.S.); [email protected] (K.V.); [email protected] (H.H.); [email protected] (M.-L.S.); [email protected] (T.S.); [email protected] (C.M.-T.); [email protected] (P.D.); [email protected] (M.S.); [email protected] (A.S.) 2 Institute of Clinical Transfusion Medicine and Cell Therapy (IKTZ), 89081 Heidelberg, Germany; [email protected] (S.L.); [email protected] (P.P.) * Correspondence: [email protected] Received: 9 April 2020; Accepted: 13 May 2020; Published: 15 May 2020 Abstract: Background: T lymphocyte collection through leukapheresis is an essential step for chimeric antigen receptor T (CAR-T) cell therapy. Timing of apheresis is challenging in heavily pretreated patients who suffer from rapid progressive disease and receive T cell impairing medication. Methods: A total of 75 unstimulated leukaphereses were analyzed including 45 aphereses in patients and 30 in healthy donors. Thereof, 41 adult patients with Non-Hodgkin’s lymphoma (85%) or acute lymphoblastic leukemia (15%) underwent leukapheresis for CAR-T cell production. -
Transfusion Reactions 7
HEMATOLOGY Immunohematology, transfusion medicine and bone marrow transplantation Institute of Pathological Physiology First Facultry of Medicine, Charles University in Prague http://patf.lf1.cuni.cz Questions and Comments: MUDr. Pavel Klener, Ph.D., [email protected] Presentation in points 1. Imunohematology 2. AB0 blood group system 3. Rh blood group system 4. Hemolytic disease of the newborn and neonatal alloimmune thrombocytopenia 5. Pre-transfusion examinations 6. Transfusion reactions 7. Transfusion medicine and hemapheresis 8. HLA system 9. Stem cell/ bone marrow transplantation Origins of immunohematology and transfusion medicine Imunohematology as a branch of medicine developed hand in hand with the origins of transfusion therapy. It focuses on concepts and questions associated with transfusion therapy, immunisation (as a result of transfusion therapy and pregnancy) and organ transplantation. In 1665, an English physiologist, Richard Lower, successfully performed the first animal- to-animal blood transfusion that kept ex-sanguinated dogs alive by transfusion of blood from other dogs. In 1667, Jean Bapiste Denys, transfused blood from the carotid artery of a lamb into the vein of a young man, which at first seemed successful. However, after the third transfusion of lamb’s blood the man suffered a reaction and died. Due to the many disastrous consequences resulting from blood transfusion, transfusions were prohibited from 1667 to 1818- when James Blundell of England successfully transfused human blood to women suffering from hemorrhage at childbirth. Revolution in 1900 In 1900 Karl Landsteiner discovered the AB0 blood groups. This landmark event initiated the era of scientific – based transfusion therapy and was the foundation of immunohematology as a science. -
How Do I Perform Whole Blood Exchange?
HOW DO I? How do I perform whole blood exchange? † † † David Ming-Hung Lin ,1, Joanne Becker,2, YanYun Wu,1 and Laura Cooling3, here are a number of clinical scenarios in which crossmatched against plasma or adsorbed plasma, if avail- simultaneous exchange of the patient’s plasma able. Because preparation of reconstituted WB is considered and red blood cells (RBCs) are indicated. Some of an open system with a 24-hour outdate, we prepared only these clinical indications for therapeutic whole one reconstituted WB unit at a time (i.e., after dispensing Tblood exchange (WBEx) include hemolytic disease of the one unit, the next unit was prepared). WBEx was performed newborn, severe autoimmune hemolytic anemia (AIHA), by physically removing WB with a syringe, followed by infu- – babesiosis, sickle cell disease, and hyperleukocytosis.1 4 sion of reconstituted WB. In adult patients, this involved WBEx has been performed with manual, semiautomated, removal of 200 mL (50 mL per draw with 60-mL syringes) and fully automated methods using replacements fluids over 10 minutes through a triple-lumen central venous (i.e., RBCs with plasma, RBCs with 5% albumin, and whole catheter, followed by infusion of WB over 1 to 1.5 hours. blood [WB]) reconstituted to a prespecified target hemato- Overall, it required 20 hours to complete a manual WBEx crit (Hct); however, methodologies vary widely and each exchange with 12 units of WB as replacement. For pediatric carry advantages and disadvantages. Here, we describe our patients, a similar process was followed using a central or combined experiences in performing WBEx, including clini- femoral venous catheter (5 mL/kg per draw). -
Leukopak PBMC Sample Processing for Preparing Quality Control Material to Support Proficiency Testing Programs
JIM-11874; No of Pages 8 Journal of Immunological Methods xxx (2014) xxx–xxx Contents lists available at ScienceDirect Journal of Immunological Methods journal homepage: www.elsevier.com/locate/jim Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs Ambrosia Garcia a, Sarah Keinonen a, Ana M. Sanchez a, Guido Ferrari a,d,e, Thomas N. Denny a,b,e, M. Anthony Moody a,c,⁎ a Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA b Departments of Medicine, Duke University Medical Center, Durham, NC, USA c Departments of Pediatrics, Duke University Medical Center, Durham, NC, USA d Departments of Surgery, Duke University Medical Center, Durham, NC, USA e Duke Global Health Institute, Duke University Medical Center, Durham, NC, USA article info abstract Article history: External proficiency testing programs designed to evaluate the performance of end-point Received 19 November 2013 laboratories involved in vaccine and therapeutic clinical trials form an important part of Received in revised form 14 May 2014 clinical trial quality assurance. Good clinical laboratory practice (GCLP) guidelines recommend Accepted 31 May 2014 both assay validation and proficiency testing for assays being used in clinical trials, and such Available online xxxx testing is facilitated by the availability of large numbers of well-characterized test samples. These samples can be distributed to laboratories participating in these programs and allow Keywords: monitoring of laboratory performance over time and among participating sites when results Proficiency testing are obtained with samples derived from a large master set. The leukapheresis procedure Leukocytes provides an ideal way to collect samples from participants that can meet the required number Leukapheresis of cells to support these activities. -
Leukapheresis: an Overview
IMPORTANCE OF IMMUNE CELLS IN RESEARCH Your immune cell donation may assist researchers to advance medical treatments, lead to a scientific breakthrough or even develop cures for certain diseases or disorders. Immunologists worldwide have a need for high quality immune cells and cellular subsets, and this is where you come in! Researchers will use donations like yours in an attempt to find novel ways to prime the immune system against cancers and other diseases such as HIV, auto-immune disorders, multiple sclerosis, Crohn’s, CONTACT US allergies and asthma. Immunotherapy treatments are especially effective against lung cancer, skin cancer and blood cancers such (267) 310-1400 LEUKAPHERESIS: as leukemia and lymphoma. [email protected] AN OVERVIEW biospecialty.com WHITE BLOOD CELL DONATION PROCESS Blood is made up of many components, specifically platelets, red blood cells, plasma and white blood cells, which can all be Biological Specialty Company individually collected. FDA-registered donor center operating under Investigational Review Board (IRB) approval 2165 N. Line Street | Colmar, PA 18915 1401 W. Green Street | Allentown, PA 18102 22 South 4th Street | Reading, PA 19602 LEUKAPHERESIS, noun leu· ka· phe· re· sis | \ ˌlü-kə-fə-ˈrē-səs\ The process of leukapheresis allows for peripheral blood Derived from the latin roots mononuclear cells (PBMCs) to be collected from the blood while returning red blood cells, platelets and plasma back to the donor. An of leuk (meaning white) and apheresis machine is used to draw blood through a vein in one arm, aphaeresis (translates to take remove the needed component and return the unneeded parts back away). -
Peripheral Blood Stem Cell Transplantation As an Alternative to Bone Marrow Transplantation: an Overview
Henry Ford Hospital Medical Journal Volume 39 Number 2 Article 10 6-1991 Peripheral Blood Stem Cell Transplantation as an Alternative to Bone Marrow Transplantation: An Overview Nalini Janakiraman Follow this and additional works at: https://scholarlycommons.henryford.com/hfhmedjournal Part of the Life Sciences Commons, Medical Specialties Commons, and the Public Health Commons Recommended Citation Janakiraman, Nalini (1991) "Peripheral Blood Stem Cell Transplantation as an Alternative to Bone Marrow Transplantation: An Overview," Henry Ford Hospital Medical Journal : Vol. 39 : No. 2 , 103-107. Available at: https://scholarlycommons.henryford.com/hfhmedjournal/vol39/iss2/10 This Article is brought to you for free and open access by Henry Ford Health System Scholarly Commons. It has been accepted for inclusion in Henry Ford Hospital Medical Journal by an authorized editor of Henry Ford Health System Scholarly Commons. Peripheral Blood Stem Cell Transplantation as an Alternative to Bone Marrow Transplantation: An Overview Nalini Janakiraman, MD' Slem cells capable of resloring hemalopoiesis following lethal bone marrow injury circulate in Ihc blood of many animals, including humans. When collected ihrough leukapheresis and reinfused following high-dose chenwiherapy, slem cells offer a Irealmenl optiim not currently open lo some patients who are unable lo undergo autologous hone marrow transplantation because of tumor involvement in the pelvis, prior pelvic radiation, or intolerance to general anesthesia. After stem cell infusion, hematologic and immunologic recovery are rapid in comparison lo that after autologous hone marrow reinfusion: however, in some cases platelet engraftment is slower. There is some evidence lhal tumor conlaminalion in the peripheral hlood is much less than in the marrow. -
Blood Transfusions an Overview
Blood Transfusions: An Overview Jassin M. Jouria, MD Dr. Jassin M. Jouria is a medical doctor, professor of academic medicine, and medical author. He graduated from Ross University School of Medicine and has completed his clinical clerkship training in various teaching hospitals throughout New York, including King’s County Hospital Center and Brookdale Medical Center, among others. Dr. Jouria has passed all USMLE medical board exams, and has served as a test prep tutor and instructor for Kaplan. He has developed several medical courses and curricula for a variety of educational institutions. Dr. Jouria has also served on multiple levels in the academic field including faculty member and Department Chair. Dr. Jouria continues to serves as a Subject Matter Expert for several continuing education organizations covering multiple basic medical sciences. He has also developed several continuing medical education courses covering various topics in clinical medicine. Recently, Dr. Jouria has been contracted by the University of Miami/Jackson Memorial Hospital’s Department of Surgery to develop an e-module training series for trauma patient management. Dr. Jouria is currently authoring an academic textbook on Human Anatomy & Physiology. Abstract Being able to replace blood and blood components that a patient has lost or that his or her body is not able to produce is a vital part of providing excellent medical care. With the aid of donor blood, or even sometimes the patient’s own blood that has been previously banked, medical professionals have a safe strategy for treatment of patients who have lost blood to illness or injury. This course will explain the different types of blood products, the requirements for performing a transfusion, and how to recognize and respond to complications of the transfusion process. -
Case Reports
CASE REPORTS units that were group A, D+, E−, K−, and Fy(a−). Severe delayed hemolytic transfusion reaction Although anti-Le a was microscopically positive at poly - due to anti-Fy3 in a patient with sickle cell disease ethylene glycol (PEG) IgG, anti-Lea is not routinely undergoing red cell exchange prior to matched for at the study institution nor had been hematopoietic progenitor cell collection for gene matched for with transfusions at his primary medical therapy facility. After RCE, his Hb rose from 9.3 to 11.2 g/dL, and his HbS% decreased from 78% to 22% (HbA% of 72%). To our knowledge, most patients with sickle cell di- The following day, the patient was given a single 240 sease (SCD) who have undergone hematopoietic progen - µg/kg dose of plerixafor for HPC mobilization and started itor cell (HPC) collection for gene therapy have been con - leukapheresis about 3 hours afterward. He had no ditioned with a series of monthly simple or exchange adverse events and was discharged home after his leuka - transfusions. The rationale for this practice is to improve pheresis. safety and decrease bone marrow inflammation, poten - Five days after RCE, the patient developed throbbing + tially leading to higher CD34 mobilization and low back pain, subjective fevers, dark urine, and scleral decreased risk of adverse events during HPC collection. icterus, symptoms differing from his typical vaso-occlu - + Whether transfusion actually improves CD34 mobiliza - sive crises usually manifesting as right-sided flank/upper tion is not clear however, and we previously showed that back discomfort and priapism. -
A Hospital Based Retrospective Study of Factors Influencing Therapeutic Leukapheresis in Patients Presenting with Hyperleukocyti
www.nature.com/scientificreports OPEN A hospital based retrospective study of factors infuencing therapeutic leukapheresis Received: 16 June 2017 Accepted: 20 November 2017 in patients presenting with Published: xx xx xxxx hyperleukocytic leukaemia Yanxia Jin1, Shishang Guo2, Qin Cui1, Sichao Chen1, Xiaoping Liu1, Yongchang Wei3,5, Yunbao Pan 4,5, Liang Tang6, Tingting Huang1, Hui Shen1, Guanghui Xu6, Xuelan Zuo1, Shangqin Liu1, Hui Xiao1, Fei Chen1, Fayun Gong6 & Fuling Zhou1,3,4 Therapeutic leukapheresis is a rapid and efective method to reduce early mortality of patients with hyperleukocytic leukaemia (HLL). However, few studies on factors infuencing the efciency have been reported. In this study, 67 cases who underwent leukapheresis were retrospectively analysed and factors related to the collection efciency of leukapheresis (CEWBC) were also evaluated. Paired t test showed that there was a signifcant decrease in statistics of white blood cell (WBC) counts after apheresis. The results of two independent samples nonparametric test suggested that WBC counts, platelet (PLT) counts, haematocrit (HCT), hemoglobin (HGB), serum chlorine (Cl) and globulin (GLB) before leukapheresis correlated with the CEWBC. Multiple linear regression analysis with background stepwise variable selection indicated that only WBC and HCT before leukapheresis had an infuence on CEWBC signifcantly. Kaplan-Meier analysis and Cox regression model indicated that lymphocyte (LY) and mean corpuscular hemoglobin (MCH) pre-apheresis as independent factors signifcantly afected the prognostic survival of patients with HLL. Moreover, platelets and red blood cell were contaminated in the product of leukapheresis. It is an urgent problem to be solved in order to realise higher efcacy and higher purity of WBC collection to improve the survival of patients with HLL through optimising instruments.