BACKGROUND: Peripheral stem cell collections can be challenging in the pediatric population and respective experience is limited. Since February 2015 our institution is utilizing the new Spectra Optia (Optia) apheresis device, which has replaced the former COBE Spectra (COBE) device. As a quality initiative we collected and compared collection efficiency (CE2) and other collection variables between the two devices. STUDY DESIGN AND METHODS:In this retrospective study we collected and compared clinical, laboratory, and technical collection data from stem cell collection procedures done with the Optia and COBE devices. The collected data included patient demographics, precollection peripheral CD341 cell counts, total CD341 cells collected, complete blood count, electrolytes before and after collection, side effects attributed to the collection, total blood volumes processed (TBVs), collection times, and calculated CE2 and collection ratios.RESULTS: Forty-one collection procedures performed on 29 pediatric patients with the Optia device were compared to 41 collections performed on 27 patients with the COBE device. The TBVs through the Optia device were significantly smaller than the COBE (3.9 6 0.2 3 TBV vs. 5.5 6 0.1 3 TBV, respectively; p < 0.001), requiring significantly less anticoagulant and providing similar amounts of stem cells while collection times were significantly shorter (mean, 238 6 9 min vs. 264 6 9 min, respectively; p < 0.05). Collections on the Optia caused significantly smaller reductions of plasma calcium and magnesium. No significant side effects attributed to the procedure were noted.CONCLUSION: Stem cell apheresis with the Optia device in children is safe and feasible with smaller blood volumes with shorter collection times.A utologous stem cell transplantation (ASCT) is an integral part of the treatment of various pediatric cancers including high-risk neuroblastoma, various brain tumors, retinoblastoma, bone and soft tissue sarcomas, and lymphomas.1-5 The initial part of the ASCT process requires collection of stem cells, which can be challenging in the pediatric population, especially for low-weight patients such as babies and toddlers, who are more prone to hemodynamic influences of fluid shifts due to the circulating blood volumes and to the exposure to anticoagulants and who may have more difficulty with the prolonged duration of the collection procedure.6-8Our medical center performs approximately 50 ASCTs per year for pediatric patients. In February 2015 our institution introduced the novel Spectra Optia MNC (Optia) apheresis device for the collection of mobilized peripheral stem cells, which has eventually replaced the former COBE Spectra (COBE) device (both from TerumoBCT).Both devices use centrifugation for blood separation, but have some major mechanical differences. The Optia ABBREVIATIONS: ASCT(s) 5 autologous stem cell transplantation(s); BW 5 body weight; CR(s) 5 collection ratio(s); iCa 5 ionized calcium; TBV(s) 5 total blood volume(s) processed. device has a more advanced au...
BACKGROUND:The manufacturing of cellular products for immunotherapy, such as chimeric antigen receptor T cells, requires successful collection of mononuclear cells. Collections from children with high-risk leukemia present a challenge, especially because the established COBE Spectra apheresis device is being replaced by the novel Spectra Optia device (Optia) in many institutions. Published experience for mononuclear cell collections in children with Optia is lacking. Our aim was to compare the two collection devices and describe modified settings on the Optia to optimize mononuclear cell collections. STUDY DESIGN AND METHODS:As a quality initiative, we retrospectively collected and compared data from mononuclear cell collections on both devices. Collected data included patient's clinical characteristics; collection parameters, including precollection lymphocyte/ CD3 counts, total blood volumes processed, runtimes, and side effects (including complete blood count and electrolyte changes); and product characteristics, including volumes and cell counts. Collection efficiencies and collection ratios were calculated. RESULTS:Twenty-six mononuclear cell collections were performed on 20 pediatric patients: 11 with COBE and 15 with Optia. Adequate mononuclear cell products were successfully collected with a single procedure from all patients except one, with mean calculated mononuclear cell collection efficiency that was significantly higher from Optia collections compared with COBE collections (57.9 6 4.6% vs 40.3 6 6.2%, respectively; p 5 0.04). CD3-positive yields were comparable on both machines (p 5 0.34) with significantly smaller blood volumes processed on Optia. Collected products had larger volumes on Optia. No significant side effects attributed to the procedure were noted. CONCLUSION:Mononuclear cell apheresis using the Optia device in children is more efficient and is as safe as that with the COBE device.T reating patients who have therapy-resistant or high-risk, relapsed acute lymphoblastic leukemia (ALL) is challenging.1,2 Cellular therapies using chimeric antigen receptor (CAR)-transfected T cells is currently being investigated as a promising new immunotherapeutic treatment modality.3 To manufacture CAR T cells, mononuclear cells (MNCs) from the patient need to be collected beforehand. 4 Recently, manufacturer support for the commonly used COBE Spectra (COBE) apheresis device has been discontinued, and many centers are replacing the COBE device with the new Spectra Optia (Optia) device (both from Terumo BCT). Both devices use centrifugation for blood separation, but they have different operating systems and collection techniques. The COBE device operates on manual color coordination, which requires intermittent manual interface control and repositioning by the operator based on the product color and aspect of the product aspired through the collect port. The Optia device, on the other hand, automates this process through an advanced automated interface management system, which provides constant feedback ...
Background Peripheral hematopoietic stem cell (HSC) collections are needed for autologous hematopoietic stem cell transplantation (HSCT). Since 2015, our institution has utilized a secondary chamber mononuclear cell (MNC) protocol on the Spectra Optia apheresis system. Recently, a new continuous mononuclear collection protocol (CMNC) was developed for the same device. As there is limited data available regarding the use of the CMNC protocol in children, we compared collection efficiency (CE2), side effects, and clinical feasibility between the two protocols in patients <18 years old. Study Design and Methods We prospectively collected clinical, laboratory, and technical collection data from HSC collection procedures performed with the Spectra Optia apheresis system utilizing the CMNC protocol. Data were compared to retrospectively collected data utilizing the MNC protocol. Data collection included donor demographics, precollection peripheral CD34+ cell counts, total CD34+ cells collected, collection efficiency, side effects, and collection product characteristics. Results A total of 96 HSC collection procedures were performed on 79 pediatric patients utilizing either the MNC (61 patients) or CMNC (18 patients) protocol. The collection efficiencies were comparable between MNC and CMNC cohorts (52.9% vs 54.9%, P = 0.711). Platelet loss was significantly lower in the CMNC cohort (P = 0.002), especially in children weighing <15 kg. Product volumes were higher with CMNC. No significant collection‐related side effects were noted with either protocol. Conclusions MNC and CMNC protocols have comparable collection efficiencies and are both feasible and safe for the use in children. Centers may choose between the methods depending on clinical needs.
To determine if the use of plerixafor during mobilization of stem cells play a role in the devepment of engraftment fever. Methods: We retrospectively reviewed Medical records from of all patients who underwent an autologous HSCT at the Audie L. Murphy Memorial VA Hospital between 2011 to 2015. Data were gathered on the use of plerixafor for mobilization of cells, transplant diagnosis, conditioning regimen, number of CD34 + and nucleated cells infused, timing of fever, timing of engraftment (defined as recovery of peripheral neutrophil count above 500 cells per microliter), and length of hospital stay. Peri-engraftment fever was defined as temperature >100.4 F with onset between four days prior to and two days after engraftment, with negative infectious workup. Results: 255 patients underwent an autologous HSCT between 2011 to 2015. Of those, 162 (64%) patients developed fever, and 90 (35%) met our criteria for peri-engraftment fever. All patients received filgrastim, and 128 (50%) also received plerixafor for stem cell mobilisation. No association was found between use of plerixafor and peri-engraftment fever (OR .804, 95% CI .480-1.345, P = .405). The doses of nucleated cells (OR .967, CI .926-1.011, P = .136) and CD34 + stem cells (OR .996, CI .908-1.093, P = .935) infused did not correlate with periengraftment fever. Patients 60 years of age or older were more likely to develop peri-engraftment fever than younger patients (OR 1.833, CI 1.045-3.214, P = .034). Peri-engraftment fever was also more common in patients with multiple myeloma than those with other diagnoses (OR 2.189, CI 1.164-4.116, P = .015). Conclusion: The use of plerixafor does not appear to increase the risk of fever during engraftment following autologous HSCT in the population studied.
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