The concept of gene therapy dates back to the 1960s and 1970s and it is yet to come of age, as there is a paucity of reliable, long-term data on the safety and efficacy of this novel therapy. It is fast emerging as a promising approach to treat, cure or prevent genetic based diseases by correction of defective genes that are responsible for disease development. Gene therapy is a key treatment strategy for disorders caused by a missing or faulty gene. It involves introduction of functional genes into appropriate cells so that they can produce sufficient amounts of proteins, encoded by the transferred gene or turn off genes that are causing problems and eventually resulting in permanent correction of the disorder. While the concept of gene replacement therapy is mostly suitable for recessive diseases, novel strategies have been suggested that are capable of also treating conditions with a dominant pattern of inheritance. Gene therapy treatments are of broadly two types, Germline gene therapy, & Somatic Germline gene therapy. There are two methods for administering gene therapy -Ex vivo & in-vivo. There are two main parts to gene replacement: Genes and Vectors. Gene therapy is useful for hematologic conditions as Hemoglobinopathies, Hemophilia and Inherited bone marrow failure. Future Prospective of Gene Therapy in Transfusion Medicine ,work is being done to explore ex vivo generation of RBCs utilizing various cell fractions, including hematopeitic progenitor cells from cord blood and adult sources. Cost of therapy and ethical issues are the limiting factors for the use of Gene therapy.

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Background and Objectives: Indian studies on evaluation of storage lesions in red blood cells (RBCs) are either limited to 21 or 28 days or have evaluated limited parameters for 42 days. Moreover, issue of transfusion of “fresh” versus “old” RBC is far from settled. The study serially assesses, up to 42 days, in vitro and in vivo RBC storage lesion parameters, including di-(2-ethylhexyl) phthalate (DEHP) leaching and its comparison with published literature. Methods: The study serially assessed in vitro RBC storage lesion parameters including potassium, lactate, glucose, pH, supernatant hemoglobin, percentage-hemolysis, and DEHP leaching of RBC unit during storage till 42 days. The study also evaluated in vivo recovery of potassium after transfusion of “older” RBC. Results: Serial monitoring of in vitro biochemical parameters showed increase in potassium, lactate, supernatant Hb, and hemolysis% and reduction in glucose and pH. DEHP content of the RBC bag was within no-observed adverse effect limit on days 42. Measurement of serum potassium after transfusion of “older” RBC unit revealed that levels of potassium were within normal limit in all four patients. Sterility testing done on days 42 was negative for all 24 bags. Conclusion: Development of storage lesions is inevitable. Appropriate storage limits the RBC lesions to within normal limits. The increase in potassium, lactate, or hemolysis consequent to aging of blood has little clinical significance in routine transfusion practice.

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Background & Objectives: Hyperthrombocytosis may cause acquired thrombosis-related symptoms and fatal vascular complications. Currently, therapeutic platelet reduction (TPR) with medical therapy remains the mainstay of hyperthrombocytosis management. We encounter patients with high platelet counts with requests for TPR. Here, we share our experience of TPR procedures in patients with symptomatic hyperthrombocytosis due to various underlying etiologies. Methods: The study from January 2013 to October 2020 included 36 patients of hyperthrombocytosis who underwent 82 TPR procedures by apheresis technology. Patient details were obtained from the treatment file and all procedures were performed following recommended instructions and protocol. Statistical analysis was done using the SPSS statistical package. Results: The median age of patients was 53 years with mean hemoglobin, platelet count, plateletcrit, and platelet distribution width of 9.9 g/dL, 1711.3 × 10⁶/mL, 0.57%, and 43.4%, respectively. A total of 26 patients had primary thrombocytosis. The mean TPR procedure time, whole blood volume processed, and anticoagulant used were 162 min, 5070 mL, and 430.3 mL, respectively. The mean reduction of platelets in patients who underwent two and three procedures was 72.4% and 82.7%, respectively (P = 0.003). Conclusion: We conclude that TPR is a useful method in reducing platelet count rapidly in hyperthrombocytosis. It relieves patients of acute symptoms and prevents thrombotic events. The decision to perform TPR should be individualized and based on the clinical scenario, degree of thrombocytosis, and risk factors associated with TPR procedures.

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Background and Objectives: Red blood cell (RBC) transfusion continues to be administered on the basis of conventional wisdom and the notion of an average benefit per unit. The present study was aimed at estimating the hemoglobin (Hb) content in packed red blood cell (PRBC) units in three types of blood donors: Replacement blood donor (RD), First time voluntary blood donors (FTVD), and Regular/Repeat voluntary blood donors (RTVD). Methods: A total of 900 blood donors were divided equally into three groups of blood donors. Within each group, 100 collections were done in Double 350 ml, Triple 450 ml and quadruple 450 ml blood bags, respectively. The Hb concentration of the PRBC unit was done after the collection of representative samples from the PRBC unit. The volume of the PRBC unit was estimated by the formula: Weight of PRBC divided by its specific gravity. The net Hb content in the PRBC unit was calculated by the formula: Hb of PRBC multiply by its volume. Results: Net Hb content of 900 PRBC units were in the range of 30.77–87.36 g; mean was 52.91 ± 9.99 g. Net Hb content of PRBC bag was lower in PRBC prepared from RD as compared to FTVD and RTVD. We observed a range of net Hb content in the PRBC units and Hb content strongly correlated with the volume of PRBC. Conclusion: The present study shows that there is a range of Hb content of PRBC units. Adopting a policy of optimizing the dosage of RBC transfusion could have the potential to significantly improve RBC use and decrease patient exposure to allogeneic blood.

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Background and Objectives: Although unexpected antibody screening is mandatory according to the Food and Drug Administration and National Blood Policy, the prevalence of irregular red cell antibody and its specificities are not much reported in the donor population of western India. The objective of this study is to find the prevalence of unexpected antibodies in healthy blood donor population of western India. Methods: This is a retrospective study conducted in one of the largest stand-alone blood centers in western India. Data were retrieved from the Integrated Blood Bank Management System (powered by the blood center located in Ahmedabad) software. The data were analyzed for a period of 24 months, from March 1, 2019, to March 31, 2021. Unexpected antibody screening of all voluntary healthy blood donors was performed with fully automated blood grouping equipment Immucor NEO and Diagast EVO using commercial Capture-R Ready Indicator Red Cells (Immucor, USA) and Hemascreen Pool (Diagast, France). Further antibody identification was performed with 11 cell panels. Results: A total of 53,724 volunteer blood donors donated at our blood center during the study period comprised 51,185 (95.27%) male donors and 2539 (4.72%) female donors. A total of 25 (0.046%) donors showed the presence of unexpected antibodies. Most frequent alloantibodies were anti-M (n = 4, 16%) and multiple antibody (n = 4, 16%). Conclusion: Implementation of unexpected antibody screening in all the healthy blood donors routinely and identification of antibodies in antibody screen-positive donors helped us to understand the prevalence of antibodies in our region and its importance in providing compatible blood components which are devoid of irregular antibodies and to avoid delayed transfusion reactions.

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Introduction: Anti-C^w is a low-frequency antibody against C^w (Rh8) antigen, a low incidence antigen of the Rh system. Anti-C^w antibody may cause mild to moderate hemolytic disease of the fetus and newborn (HDFN) and mild to severe immediate or delayed hemolytic transfusion reactions (HTR). The antigenic frequency of C^w in the Indian population is 1.25%. Two cases of Anti-C^w antibody are being reported which were detected during routine antibody screening, one an oncology patient and the other a healthy blood donor. Case 1: A 30-year-old male, known case of acute myeloid leukemia, with previous history of induction chemotherapy and blood transfusion was admitted for further management and chemotherapy. When three cell antibody screening was performed using an automated platform, the screen was positive with +2 reactions. Antibody identification using 14 cells suggested the presence of an Anti-C^w antibody. On further testing, the patient red blood cell (RBCs) were negative for C^w antigen. Case 2: A 20-year-old male, first-time, voluntary blood donor, with no history of blood transfusion donated whole blood. On performing three cell antibody screening using automated platform, screen was found to be positive with +3 reactions. Antibody identification performed using 14 cell panel suggested the presence of Anti-C^w antibody. On further testing, the donor RBCs were negative for C^w antigen. Conclusion: Antibody screening and identification is recommended in pretransfusion testing, especially in multi-transfused patients and patients belonging to the reproductive age group, so that antibody to low-frequency antigen can be detected and its potential to cause HTR and HDFN can be assessed.

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Background and Objectives: Blood transfusion is a life-saving procedure and the selection of healthy blood donors is essential steps for safe blood transfusion. Proper selection of blood donors is needed for the safety of both blood donors and recipients. The aim of this study was to assess the demographic profile of blood donors and determine the frequency and reason of donor deferral in a university hospital of Nepal. Methods: This hospital-based retrospective study was carried out in the Blood Bank Unit of the tertiary care center of Nepal. Data were collected from the record book maintained in the blood bank from January 2016 to December 2020. Data were analyzed using Microsoft Office Excel 2010 for descriptive analysis. Results: A total of 3697 individuals came for blood donation during the study period; among them, 2802 (75.8%) were male and 895 (24.2%) were female. Total number of voluntary donation were 2175 (58.8%), while 1522 (41.2%) were family/replacement donation. Among all donors, 351 (9.5%) donors were deferred for different reasons. The most common cause of donor deferral was hypertension (15.0%), followed by medication (14.0%), while anemia (32.8%) was the leading cause of deferral in female donors. Out of total deferral cases, 92.6% of donors were temporary deferral, while 7.4% were deferred permanently. Conclusion: Most deferrals were temporarily due to hypertension, medication, and anemia. Awareness about these causes of deferral can increases the donor pool.

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Background and Objectives: Blood services are facing a shortage of blood all over the world. Demand for blood is rising day by day and current blood donation is insufficient to meet the demand. This study was planned to assess the myths of college-going students regarding blood donation, address their misconceptions, and raise awareness among college students on the importance of blood donation. Methods: The study population comprised 1000 students above the age of 18 years who qualify for blood donation after assessment of suitability to donate blood as per the blood donor questionnaire and consent form of the department. Results: Myths and misconceptions were more prevalent among nonblood donor students. The most common reason for not donating blood, as stated by nonblood donor students, was fear of needle pain in 137 (27.4%), followed by being not fit to donate in 134 (26.8%) and the fear of becoming weak in 95 (19%). Conclusion: The most common reason comes out to be related to health of the individual donor; almost one in two college-going students (45.8%) fear that either they are not fit enough to donate blood (26.8%) or that they will become weak (19%) after blood donation.

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A 4-month-old male child presented with a history of seizure and vomiting. There was no history of fever, fall, or any other trauma. On examination, there was anisocoria, and anterior fontanelle was bulging and nonpulsating. Computerized tomography revealed an acute on chronic bilateral subdural hematoma (left > right) with a midline shift. He had no relevant past or family history suggestive of any bleeding disorder. Blood investigations revealed anemia with prolonged prothrombin time (PT)/international normalized ratio/and activated partial thromboplastin time (APTT). Mixing study was done and it showed a correction with pooled normal plasma. The possibility of coagulation factor deficiency was confirmed. Further, mixing studies and factor assays revealed normal levels of fibrinogen and Factor VIII, with a reduced level of Factor IX. Since both PT and APTT were prolonged and Factor IX level was low, a deficiency of Vitamin K-dependent coagulation factors was suspected. The child was immediately given intravenous Vitamin K injection. The diagnosis of Vitamin K deficiency bleeding (VKDB) was confirmed by protein induced by Vitamin K absence testing. Unfortunately, the child succumbed to the complications of the intracranial bleed.

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Background and Objectives: Anemia during peripheral blood stem cells (PBSCs) transplant is considered a bad prognostic marker. The study aimed to determine whether pretransplant anemia influence peritransplant transfusion requirements in myeloma patients. Methods: Myeloma patients planned for PBSC transplant were stratified based on hemoglobin levels at time of mobilization, PBSC collection, and PBSC infusion. Univariate and multivariate analysis was performed to study the predictors for good mobilization, adequate CD34 yield by apheresis, and red blood cell (RBC) transfusion in the peritransplant period. Results: Of 67 patients, the prevalence of anemia at mobilization, PBSC collection, and PBSC infusion was 37%, 58%, and 70%, respectively. Eighty-five percent had good mobilization with peripheral blood CD34 count of 50 cells/μl (8–123) and 81% had adequate CD34 yield with first apheresis. Thirty-two percent patients received peritransplant RBC transfusion with the median of one unit (range: 0–5). Anemia on the day of infusion did influence the RBC transfusions in the peritransplant period (P = 0.03). Conclusion: One third of myeloma patients require RBC transfusion support in the peritransplant period. We identified pretransplant anemia neither influenced mobilization nor PBSC collection but increased the risk for RBC transfusion in the peritransplant period.

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Transfusion medicine has been successfully practiced in North Macedonia for 76 years. Since its foundation, the Transfusion Medicine Unit is constantly growing and developing through the experiences of a large number of professional medical workers who left a lasting mark and paved the way toward modern transfusion activity. The Institute for transfusion medicine of North Macedonia constantly follows the latest world achievements in the field of transfusion medicine and they invest their energy in constant education, new technologies, and appropriate practices that ensure a high level of health services for donors and patients. This manuscript presents the journey of transfusion medicine in the Republic of North Macedonia covering various topics like the History, changes in legislation over time, blood donation activity ,other services and the future directions for the field of transfusion medicine in the country.

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In 1963, Mongolian blood transfusion service was established officially with the independent creation of Blood Transfusion Central Station in Ulaanbaatar. In the following year of 1964, rural blood centers were organized under the provincial central hospitals in all provinces, thus blood transfusion care and service has started nationwide. As part of the continuous improvement of the legal framework for the blood transfusion sector, the Donor Law of Mongolia was adopted in 2000, amended in 2012, and revised in 2018. In 1994, Mongolian blood transfusion service has shifted from paid blood donation practice to the nonremunerated and has achieved a 100% voluntary nonremunerated blood donor, in 2016. The World Health Organization recommends that in low- and middle-income countries, the share of blood donors in the total population to be 1.5. As of 2020, this figure has reached at 1.8% in Ulaanbaatar. The National Center for Transfusion Medicine (NCTM) has introduced drastic technological innovations in blood and blood products (BBP) production periodically. Since 2007, the NCTM has been implementing three international standards in its activity including requirements for quality and competence for medical laboratories MNS ISO 15189:2015, quality management system MNS ISO 9001:2016, and occupational health and safety management system OHSAS 18001:2007/MNS OHSAS 18001/2012. In 2020, the Mongolian blood transfusion service provided safe and quality assured BBP to health care organizations with 100% of fulfillment nationwide.

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Background and Objectives: Measurement of actual concentration of IgG requires methods like heat inactivation (HI) of serum. This study was aimed at comparing of heat-treated ABO titers performed by conventional test tube technique (CTT) and column agglutination technique (CAT) with hemagglutination (HA)/solid-phase red cell adherence (SPRCA). Methods: This was a prospective, observational study conducted between October 2019 and March 2020. All consecutive A, B, and O group donors who gave consent for participation in the project were included. All samples were tested by CTT and CAT before and after HI (post DTT treatment performed by CTT [pCTT] and post DTT treatment performed by CAT [pCAT]) and with HA/SPRCA. Results: A total of 300 donors were included: 100 each with A, B, and O blood groups. For group O, IgG titers were higher than IgM titers among group O, whereas that among group A and group B, IgM titer was found to be higher than IgG titer by both HA/SPRCA and pCTT. The titer values among all the three blood groups were highest when the test was performed by pCAT, though the results of pCTT and SPRCA, pCTT, and pCAT were significant in group O donors. For groups A and B, results of pCTT and pCAT, pCAT, and HA/SPRCA were found to be statistically significant. Conclusion: Results obtained by HA/SPRCA were closer to pCTT, with respect to time consumption, expertise required, and lack of inter-observer variation. Titers obtained by pCAT were higher in comparison to pCTT obviously due to its relative higher sensitivity. Hence, these methods cannot be used interchangeably.

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Background and Objectives: Rate of blood transfusion is considerably low in transurethral resection of the prostate (TURP). We follow type and crossmatch (TC) policy in TURP. The objective was to assess the suitability of TC policy along with the impact of preoperative (preop) prostate weight and hemoglobin (Hb) on the pattern of blood ordering (whether demand for TC was sent or not). Methods: Retrospective analysis of TURP patients was done from 2014 to 2017. Patients were divided into 2 groups on the basis of whether the demand for TC was sent or not. The age, preop prostate weight and preop Hb of patients where demand for TC sent was compared with patients where TC demand was not sent. Crossmatch to transfusion ratio (Crossmatch to transfusion ratio C/T ratio), Transfusion probability (%T) and Transfusion index (TI) were calculated. Results: Among the total 92 TURP patients, 42.4% (39/92) had TC samples sent preoperatively. Only three patients (3.2%, 3/92) required transfusion intraoperatively. CT ratio was 23.6, %T was 7.6% and TI was 0.07. Preop prostate weight and Hb were significantly higher and lower, respectively, for the group where request for TC was sent. Transfusion probability was also higher for this group. Conclusion: The blood utilization indices show the inadequate utilization of blood and that TC policy is unnecessary. Type and screen policy can be used for patients with large prostate and/or low Hb while type and hold would be appropriate for rest of the patients. Change in pretransfusion policy would reduce workforce and reagent wastage along with efficient inventory management.

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Background and Objectives: ICMR conducted a multicentric trial “PLACID” that allowed COVID convalescent plasma (CCP) as an experimental drug for the management of moderate COVID-19 disease and the authors' institute was one of the participating centers. The efficacy of CCP in COVID-19 is still debatable. However, unlike therapeutic efficacy, there is not enough literature on issues and challenges faced by health-care institutions in donor recruitment, and the entire vein-to-vein process and approach of CCP transfusion. The authors would like to share their experiences, challenges faced, and their mitigation during the course of donor recruitment, screening, testing, apheresis donation, storage, inventory management, and issue and transfusion of CCP including the regulatory provisions, as their evolution. Methods: This retrospective study was conducted over a period of 7 months at a large tertiary care hospital in north India. Based on ICMR guidelines, the study analyzed the screening process and donation from all consecutive potential CCP donors. The study also identified various issues and challenges faced by the institute and how they were resolved. Results: Prospective donors registered at the blood center were 843. Majority were males (96.6%), first-time CCP donors (93%), age interval 31–45 years (52.2%), who had a history of mild COVID-19 symptoms (86.9%), and were home-quarantined (83.8%). The most common blood group was B positive (50.6%). Only 6.3% of donors were deferred due to the absence of anti-COVID-19 antibodies. Of 843, 705 selected CCP donors donated 1488 CCP units and six donors (0.8%) experienced mild adverse reactions. Challenges faced by authors included donor recruitment, lack of regulatory approval for plasmapheresis, revisions of COVID-specific selection criteria, no “anti-COVID-19 antibody” kit, and CCP inventory management. Conclusion: This study provides real-world comprehensive data on process management of CCP donors and their donations. This understanding of the process, its challenges, and their mitigation could be a template for any possible future pandemic.

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Background and Objectives: Blood centers around the globe are dependent on voluntary blood donation from healthy individuals to meet their blood supplies. The severe acute respiratory syndrome coronavirus-2 pandemic has become one of the most critical global health emergencies of modern times. Blood transfusion service (BTS) in India faced numerous challenges during the COVID-19 outbreak and the following imposed country lockdown. We aim to identify the challenges faced by a standalone blood center and explore the mitigation strategies implemented during the COVID-19 pandemic and subsequent lockdown. Methods: A cross-sectional study conducted at a standalone blood center done over a time period of 05 months including the nationwide lockdown phase. Personal invitation of donors, social media awareness, and in-house donation drives were implemented to improve donor inflow. Restricted donor entry, stringent donor selection, and adequate sanitization strategies were the key steps adopted to ensure the safety of donors and staffs. Results: After a declaration of nationwide lockdown in India, blood donation showed a drop of 13.36% and blood demand was also reduced by 25.70% in our study. Conclusions: The COVID-19 pandemic affected blood donation process and blood supply and adversely affected BTSs. BTS should always be vigilant to adopt new practices even before guidelines are set by regulatory authorities in adverse situations. Restrictive blood transfusion strategies need to be emphasized in the country.

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RHD variants are divided into three categories; weak D, partial D, and Del. The variants detection is important during donor testing and pregnancy. Studies shown that the detection of D variants may be missed by standard serologic methods including Indirect Antihuman Globulin Test and may cause anti-D immunization when exposed to D-negative individual. The limitations of serology can be overcome by RHD gene molecular typing. We describe for the first time a possible novel DBS-0 like allele partial D which revealed serological D and E negative in an Omani donor that is different from the previously described DBS-0 with serological positive D and partial E.

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Background and Objectives: The C Willis or C^w antigen is a low-incidence antigen of Rh system. The antibody against the C^w antigen (anti-C^w) is an IgG antibody which may occur naturally or may be immune in nature. The identification of C^w antibody is important since it has the potential to cause hemolytic disease of the newborn as well as hemolytic transfusion reaction. This study was conducted with the aim of determining the prevalence of C^w antibody in multitransfused thalassemic patients enrolled in a Regional Blood Transfusion Center (RBTC) of North India. Methods: A retrospective descriptive observational study was conducted at the Department of Immunohematology and Blood Transfusion, LHMC and Associated Hospitals. All transfusion-dependent thalassemic (TDT) patients and non-TDT (NTDT) patients enrolled in the RBTC of the hospital till December 2018 were included in the study. Antibody screening was performed in all recipients before each transfusion. The prevalence of anti-C^w was estimated. Results: A total of 567 thalassemic patients (including TDT and NTDT) were registered in RBTC, LHMC till December 2018. On pretransfusion antibody screening and identification, 3 out of 567 thalassemic patients were found to have alloimmunization against C^w antigen. The prevalence of anti-C^w in multitransfused thalassemics was 0.53%. Conclusion: The prevalence of anti-C^w is variable in different populations and it is not a very commonly reported antibody in patients with thalassemia. One should be aware of the approach to transfusion in thalassemic patients who develop C^w alloimmunization.

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It is a known fact that antiretroviral treatment (ART) is highly efficacious in reducing the sexual transmission of human immunodeficiency virus (HIV). In addition, it is clear now that those infected and living with HIV and having an undetectable viral load below 200 copies per mL, measured 4 to 6 monthwise, do not transmit it sexually to their partners. Therefore, U = U (Undetectable = Untransmittable; where symbol = means similar to) campaign is the message of a new UNAIDS explainer. The authors herein report the blood donation made by an HIV-I positive Indian male under the existing policy of confidential unit exclusion at their blood center. It was alarming because he was driven by an incorrect belief that being in a state of sexual nontransmissibility, due to the regular intake of ART, his donated blood was safe and suitable for blood transfusion too. He firmly believed that the ART he was receiving was highly efficacious in reducing the transmission of HIV through sexual intercourse and misconstrued the same for blood transfusion. After a thorough consultation and discussion with the transfusion medicine specialist, the individual could understand that U = U certainly, does not ascribe to the blood transfusion-related transmission due to a bigger inoculum and the intravenous route of administration.

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Neuromyelitis optica (NMO) is an inflammatory central nervous system syndrome, associated with serum aquaporin-4 immunoglobulin G antibodies. Autoantibodies against aquaporin-4 (AQP4-IgG), the principal water channel on astrocyte foot processes at the blood brain barrier, are pathogenic in NMO. Acute attacks are managed by high-dose intravenous methylprednisolone,if symptoms fail to resolve, plasma exchange is considered. Here , we present a case of NMO spectrum disorder in a 20 year old lady, failed to pharmacotherapy , was managed by plasma exchange using Spectra Optia Cell Separator machine . Detailed plasma exchange protocol, disease progression and outcome was analysed in this study.

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