Impact of DMSO Concentrations on Hematopoietic Recovery After Autologous HSC Transplantation.
NCT ID: NCT02452099
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2014-01-31
2016-12-31
Brief Summary
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Detailed Description
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The main aim of the study is to evaluate the clinical impact of reduction of DMSO concentration in cryopreservation mixture on engraftment after autologous hematopoietic stem cell transplantation. 150 consecutive patients will be randomly assigned to one of three study arms (50 patients each). HSCs obtained by leukapheresis will be cryopreserved in three concentrations of DMSO: 5%, 7.5%, 10%, respectively. Evaluation of the mixtures will be carried out by monitoring reconstitution of hematopoiesis and the frequency the side effects in patients. The most important aspect of our evaluation will be the speed of neutrophil recovery after transplantation (defined by the first day, when absolute neutrophil count in peripheral blood will be higher than 0.5 G/L). The investigators will also evaluate the toxicity of cell suspension by monitoring the frequency of infusion-related adverse events (like nausea or vomiting) during infusion and 24 hours after transplantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5% DMSO
Cryopreservation of HSCs using 5% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration.
7.5% DMSO
Cryopreservation of HSCs using 7,5% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration.
10% DMSO
Cryopreservation of HSCs using 10% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration.
Interventions
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Cryopreservation of HSCs using 5% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration.
Cryopreservation of HSCs using 7,5% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration.
Cryopreservation of HSCs using 10% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
18 Years
ALL
No
Sponsors
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Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Sebastian Giebel
Prof., MD
Locations
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MSC Memorial CAncer Center and Institute of Oncology
Gliwice, , Poland
Countries
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References
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Smagur A, Mitrus I, Ciomber A, Panczyniak K, Fidyk W, Sadus-Wojciechowska M, Holowiecki J, Giebel S. Comparison of the cryoprotective solutions based on human albumin vs. autologous plasma: its effect on cell recovery, clonogenic potential of peripheral blood hematopoietic progenitor cells and engraftment after autologous transplantation. Vox Sang. 2015 May;108(4):417-24. doi: 10.1111/vox.12238. Epub 2015 Mar 6.
Mitrus I, Smagur A, Giebel S, Gliwinska J, Prokop M, Glowala-Kosinska M, Chwieduk A, Sadus-Wojciechowska M, Tukiendorf A, Holowiecki J. A faster reconstitution of hematopoiesis after autologous transplantation of hematopoietic cells cryopreserved in 7.5% dimethyl sulfoxide if compared to 10% dimethyl sulfoxide containing medium. Cryobiology. 2013 Dec;67(3):327-31. doi: 10.1016/j.cryobiol.2013.09.167. Epub 2013 Oct 11.
Smagur A, Mitrus I, Giebel S, Sadus-Wojciechowska M, Najda J, Kruzel T, Czerw T, Gliwinska J, Prokop M, Glowala-Kosinska M, Chwieduk A, Holowiecki J. Impact of different dimethyl sulphoxide concentrations on cell recovery, viability and clonogenic potential of cryopreserved peripheral blood hematopoietic stem and progenitor cells. Vox Sang. 2013 Apr;104(3):240-7. doi: 10.1111/j.1423-0410.2012.01657.x. Epub 2012 Oct 9.
Other Identifiers
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COI-DMSO-01
Identifier Type: -
Identifier Source: org_study_id
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