Automatic interface‐controlled apheresis collection of stem/progenitor cells: results from an autologous donor validation trial of a novel stem cell apheresis device

Reinhardt, Peter; Bräuninger, S; Bialleck, Heike; Thorausch, Kristin; Smith, Richard J.; Schrezenmeier, Hubert; Seifried, Erhard; Wiesneth, Markus; Bönig, Halvard

doi:10.1111/j.1537-2995.2010.02992.x

Cited by 74 publications

(150 citation statements)

References 23 publications

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“…The apheresis target dose for one autologous SCT was ≥3×10 6 CD34+ cells/kg body weight before freezing. The collection efficiency was calculated by using the widely accepted ‘CE2’ model [1516] as follows: (Total CD34+ cells obtained from apheresis ×100)/[Peripheral CD34+ cells/µL×Apheresis volume processed (µL)].…”

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Comparison of Two Apheresis Systems of COBE and Optia for Autologous Peripheral Blood Stem Cell Collection

et al. 2017

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Peripheral blood stem cell (PBSC) transplantation following myeloablative therapy is a mainstay of treatment for various types of malignancies. This study aimed to evaluate the differences between the Optia MNC and COBE Spectra MNC systems (Terumo BCT, Japan) according to apheresis procedures and the parameters of apheresis, products, and collection. The clinical data of 74 patients who underwent autologous PBSC collection from July 2012 to July 2015 were reviewed retrospectively. The patients comprised 48 (65%) men and 26 (35%) women with a median age of 56 yr (range, 23–66 yr). Of 216 procedures, 111 (51%) and 105 (49%) were processed by using COBE and Optia MNC, respectively. PBSC collection rates, throughput, numbers of stem cells retrieved, collection efficacy, and platelet loss were compared. There were no significant differences in the median CD34+ cell counts of collected products (0.61×108 vs 0.94×108), CD34 collection efficiency (43.5% vs 42.1%), and loss of platelets (40.1% vs 44.7%). The Spectra Optia MNC apheresis system was comparable to the COBE Spectra system in collecting autologous CD34+ hematopoietic stem cells and retention of platelets.

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Comparison of Two Apheresis Systems of COBE and Optia for Autologous Peripheral Blood Stem Cell Collection

et al. 2017

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“…Although there was no difference in collection efficiency or the volume of processed blood, there was a slight difference in collected CD34+ cell numbers, with borderline statistical significance that favored the use of Spectra; this may be related to the slightly higher number of circulating CD34+ cells before collection with Spectra; the difference was no longer significant when reintegrating the seven patients and pairs of aphereses for which peripheral blood CD34+ cell counts on day 2 were not available. Successive versions of the Optia device have been validated through benchmarking with the previous generation of cell separators, both for adult 5 and pediatric 6 patients, and for donors, 7 including the collection of allogeneic blood mononuclear cells (donor lymphocyte infusions) for the latter. 8 Most recently, the possibility of predicting the collected cell dose from the circulating CD34+ cell count was demonstrated for the Optia platform, 4 like that which had previously been done for the Spectra or COM.TEC platforms.…”

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An intra-patient comparison of blood cell separators Spectra and Optia in patients and donors undergoing blood mononuclear cell collections at a single institution for subsequent autologous or allogeneic hematopoietic cell transplantation reveals comparable collection efficiencies

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Lemarié

et al. 2016

Bone Marrow Transplant

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“…In view of the currently available technologies [25, 26] this is sufficient to generate a stem cell product with an average of 5× 10E6 CD34 + donor cells/kg as per a single apheresis; this constitutes an adequate number of cells for the average PBSCT [i.e. >4× 10E6/kg (weight of recipient), and would even accommodate patients with a body weight that is somewhat higher than their donor.…”

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Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers—results of a dose escalation trial

et al. 2017

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BackgroundCertain disadvantages of the standard hematopoietic stem and progenitor cell (HSPC) mobilizing agent G-CSF fuel the quest for alternatives. We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.MethodsHealthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1–2 h infusion of 500–2500 µg/kg of balixafortide. Safety, tolerability, pharmacokinetics and pharmacodynamics were assessed.ResultsBalixafortide was well tolerated and rated favorably over G-CSF by subjects. At all doses tested balixafortide mobilized HSPC. In the dose range between 1500 and 2500 µg/kg mobilization was similar, reaching 38.2 ± 2.8 CD34 + cells/µL (mean ± SEM). Balixafortide caused mixed leukocytosis in the mid-20 K/µL range. B-lymphocytosis was more pronounced, whereas neutrophilia and monocytosis were markedly less accentuated with balixafortide compared to G-CSF. At the 24 h time point, leukocytes had largely normalized.ConclusionsBalixafortide is safe, well tolerated, and induces efficient mobilization of HSPCs in healthy male volunteers. Based on experience with current apheresis technology, the observed mobilization at doses ≥1500 µg/kg of balixafortide is predicted to yield in a single apheresis a standard dose of 4× 10E6 CD34+ cells/kg from most individuals donating for an approximately weight-matched recipient. Exploration of alternative dosing regimens may provide even higher mobilization responses. Trial Registration European Medicines Agency (EudraCT-Nr. 2011-003316-23) and clinicaltrials.gov (NCT01841476)

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Automatic interface‐controlled apheresis collection of stem/progenitor cells: results from an autologous donor validation trial of a novel stem cell apheresis device

Abstract: The Spectra Optia is a novel automatic apheresis system supporting autologous stem cell collection with at least equal efficiency and superior user-friendliness compared to the COBE Spectra MNC.

Cited by 74 publications

References 23 publications

Comparison of Two Apheresis Systems of COBE and Optia for Autologous Peripheral Blood Stem Cell Collection

Comparison of Two Apheresis Systems of COBE and Optia for Autologous Peripheral Blood Stem Cell Collection

An intra-patient comparison of blood cell separators Spectra and Optia in patients and donors undergoing blood mononuclear cell collections at a single institution for subsequent autologous or allogeneic hematopoietic cell transplantation reveals comparable collection efficiencies

Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers—results of a dose escalation trial

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