Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308133
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-03-06
Brief Title:
Biological Variables Affecting CD34 Peripheral Cells Collection Efficiency
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Biological Variables Affecting CD34 Peripheral Cells Collection Efficiency Using the Spectra Optia Continuous Mononuclear Cell Collection System Hematocrit as Determinant for CD34 Collection Efficency
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CD34CE_2023
Brief Summary:
All procedures performed during the study will comply with current clinical practice international and national guidelines Main object of the study is the PBSC apheresis procedure performed by using the continuous mononuclear cells collection cMNC system with Spectra Optia Terumo BCT specifically the biological and clinical factors affecting the procedure efficiency
Detailed Description:
Hematopoietic stem cell transplantation HSCT either autologous or allogenic is a treatment strategy widely used in the onco-hematology field and less often for other diseases1 The most employed source of stem cell is peripheral blood stem cell PBSC identified as circulating CD34 cells and collected by leukapheresis LP following mobilization process using granulocyte-colony stimulating factor G-CSF alone or in association with chemotherapy andor plerixafor the latter in case of poor-mobilizer patients
The PBSC harvest needs dedicated platform for being properly performed in our institution the Spectra Optia apheresis system Terumo BCT is routinely employed with a continuous mononuclear cells collection cMNC system Spectra Optia Terumo BCT is designed to optimize PBSC harvest through automated buffy coat interface identification and management low volume tubing set low extracorporeal volumes and support of cMNC processing system3 In the dual-step mononuclear cells collection MNC system an intermediate chamber is used to collect white blood cells while returning the majority of platelets to the subject Then optical sensors detect red blood cells RBC overflow and leucocytes are intermittently flushed in the collection bag The cMNC system differs from the former dual-step system by eliminating the intermediate collection chamber used and thus allowing continuous collection of leucocytes from the buffy coat This approach appears to be less time consuming more manageable and more efficient in returning platelet and RBC to the subject4
One of the main benchmarks of LP quality is the collection efficiency CE defined as the ratio between total CD34 cells yield in apheresis and total CD34 cells in the processed blood volume PBV
Obtaining the highest possible CE for every LP procedure is critical as long as several studies have shown the importance of targeted CD34 cells yield in order to assure a safe and rapid haematological recovery after the high dose chemotherapy regimens used in HSCT6 Therefore the objective is to reach the target PBSC yield in the safest and quickest way possible an high CE allows to reduce the PBV and the procedure length
The CE values are affected by different factors among which blood samples physical properties Such factors have been widely studied in MNC protocol7 but less studies concern the cMNC protocol8 In 147 consecutive apheresis procedures performed both on patients and healthy donors with Spectra Optia Terumo BCT with cMNC system Kondo et colleagues found a moderate positive correlation between CD34 CE and hematocrit Ht and only a very week correlation with white blood cells WBC and platelet counts We would like to confirm these data in a setting of subjects with a predominance of patients over healthy donors thus evaluating the influence of clinical and biochemical factors on CE for autologous and allogenic hematopoietic stem cell production Finally we would like to assess a possible pre-LP Ht threshold associated with a sufficient 60 CD34 CE
The PBSC harvest needs dedicated platform for being properly performed in our institution the Spectra Optia apheresis system Terumo BCT is routinely employed with a continuous mononuclear cells collection cMNC system Spectra Optia Terumo BCT is designed to optimize PBSC harvest through automated buffy coat interface identification and management low volume tubing set low extracorporeal volumes and support of cMNC processing system3 In the dual-step mononuclear cells collection MNC system an intermediate chamber is used to collect white blood cells while returning the majority of platelets to the subject Then optical sensors detect red blood cells RBC overflow and leucocytes are intermittently flushed in the collection bag The cMNC system differs from the former dual-step system by eliminating the intermediate collection chamber used and thus allowing continuous collection of leucocytes from the buffy coat This approach appears to be less time consuming more manageable and more efficient in returning platelet and RBC to the subject4
One of the main benchmarks of LP quality is the collection efficiency CE defined as the ratio between total CD34 cells yield in apheresis and total CD34 cells in the processed blood volume PBV
Obtaining the highest possible CE for every LP procedure is critical as long as several studies have shown the importance of targeted CD34 cells yield in order to assure a safe and rapid haematological recovery after the high dose chemotherapy regimens used in HSCT6 Therefore the objective is to reach the target PBSC yield in the safest and quickest way possible an high CE allows to reduce the PBV and the procedure length
The CE values are affected by different factors among which blood samples physical properties Such factors have been widely studied in MNC protocol7 but less studies concern the cMNC protocol8 In 147 consecutive apheresis procedures performed both on patients and healthy donors with Spectra Optia Terumo BCT with cMNC system Kondo et colleagues found a moderate positive correlation between CD34 CE and hematocrit Ht and only a very week correlation with white blood cells WBC and platelet counts We would like to confirm these data in a setting of subjects with a predominance of patients over healthy donors thus evaluating the influence of clinical and biochemical factors on CE for autologous and allogenic hematopoietic stem cell production Finally we would like to assess a possible pre-LP Ht threshold associated with a sufficient 60 CD34 CE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None