Optimize PBSC Harvest Through Automated Buffy CoatCD34+CE_2023NCT06308133
Biological Variables Affecting CD34+ Peripheral Cells Collection Efficiency
An observational study of Optimize PBSC Harvest Through Automated Buffy Coat, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optimize PBSC Harvest Through Automated Buffy Coat
- What is being tested?
- apheresis procedure
- How many people
- 113 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We will consider consecutive patients and donors referred to the Apheresis Unit within the Transfusional Medicine Department of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan (from 1/1/2021 to 31/12/2022) for PBSC collection. Total study population: 113 subjects of which 74 hematological/non hematological patients and 39 stem cell donors. Patients are defined as subjects affected by a hematological or non-hematological disease for which an autologous stem cells transplantation is recommended. These cases are referred as autologous use of stem cells. Stem cells donors are volunteer healthy subjects who have decided to undergo the procedures needed to collect blood stem cells. These subjects can donate their blood stem cells in favor of a blood relative or, through subscription of a specific registry (IBMDR - International Bone Marrow Donor Registry), to an unknown subject. These cases are referred as allogenic use of stem cells.
Who may be able to join
- Patients and stem cell donors who have been evaluated as suitable for PBSC apheresis and collection, either for autologous or allogenic use
- Patients and stem cell donors that have completed at least one CD34+ apheresis procedure at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan.
- Age ≥16 years
Who cannot join
- Patients affected by Acute Lymphoblastic Leukemia
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
Milan, Milano, 20122
About this study
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.
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.
Read the 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 and/or 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 sample's 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.
- Being tested
- apheresis procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apheresis procedureOther
collection of hematopoietic stem cells carried out using the single-chamber and continuous mononuclear cell (cMNC) collection system with Spectra Optia (Terumo BCT)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients are defined as subjects affected by a hematological or non-hematological disease for which an autologous stem cells transplantation is recommended. These cases are referred as autologous use of stem cells. Receives: Other: apheresis procedure | |
| Stem cells donors | Stem cells donors are volunteer healthy subjects who have decided to undergo the procedures needed to collect blood stem cells. These subjects can donate their blood stem cells in favor of a blood relative or, through subscription of a specific registry (IBMDR - International Bone Marrow Donor Registry), to an unknown subject. These cases are referred as allogenic use of stem cells. Receives: Other: apheresis procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
measured by statistical correlation
Impact, measured by statistical correlation, of clinical (age, sex, type of donor, diagnosis, recent RBC transfusion) and biochemical (pre-LP values of Ht, Hb, WBC and PLT) variables on CD34+ CE.
Measured: September 2023 - December 2023
Correlation of clinical
- Correlation of clinical (age, sex, type of donor, diagnosis, recent RBC transfusion) and biochemical variables (pre-LP values of Ht, Hb, WBC and PLT) with an adequate (≥60%) CD34+ CE.
- Correlation of pre-LP Ht levels and recent (≤ 60 days) RBC transfusion with CD34+ CE, especially in the autologous setting.
- AUROC (Area Under the ROC Curve) of a pre-LP model based on clinical parameters aimed at predicting an adequate (≥60%) CD34+ CE.
Measured: September 2023 - December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optimize PBSC Harvest Through Automated Buffy CoatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Cristina Mocellin, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308133
- Sponsor's protocol ID
- CD34+CE_2023
- Acronym
- CD34+CE_2023
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06308133
- Acronym / sponsor ID
- CD34+CE_2023 / CD34+CE_2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or 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 sample's 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: apheresis procedurePatients are defined as subjects affected by a hematological or non-hematological disease for which an autologous stem cells transplantation is recommended. These cases are referred as autologous use of stem cells. |
| Stem cells donors | – | Other: apheresis procedureStem cells donors are volunteer healthy subjects who have decided to undergo the procedures needed to collect blood stem cells. These subjects can donate their blood stem cells in favor of a blood relative or, through subscription of a specific registry (IBMDR - International Bone Marrow Donor Registry), to an unknown subject. These cases are referred as allogenic use of stem cells. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will consider consecutive patients and donors referred to the Apheresis Unit within the Transfusional Medicine Department of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan (from 1/1/2021 to 31/12/2022) for PBSC collection. Total study population: 113 subjects of which 74 hematological/non hematological patients and 39 stem cell donors. Patients are defined as subjects affected by a hematological or non-hematological disease for which an autologous stem cells transplantation is recommended. These cases are referred as autologous use of stem cells. Stem cells donors are volunteer healthy subjects who have decided to undergo the procedures needed to collect blood stem cells. These subjects can donate their blood stem cells in favor of a blood relative or, through subscription of a specific registry (IBMDR - International Bone Marrow Donor Registry), to an unknown subject. These cases are referred as allogenic use of stem cells.
Key inclusion criteria (3 listed)
- Patients and stem cell donors who have been evaluated as suitable for PBSC apheresis and collection, either for autologous or allogenic use
- Patients and stem cell donors that have completed at least one CD34+ apheresis procedure at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan.
- Age ≥16 years
Key exclusion criteria (1 listed)
- Patients affected by Acute Lymphoblastic Leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apheresis procedurecollection of hematopoietic stem cells carried out using the single-chamber and continuous mononuclear cell (cMNC) collection system with Spectra Optia (Terumo BCT) | Other | Patients, Stem cells donors |
Primary outcome
measured by statistical correlation
Time frame: September 2023 - December 2023
Impact, measured by statistical correlation, of clinical (age, sex, type of donor, diagnosis, recent RBC transfusion) and biochemical (pre-LP values of Ht, Hb, WBC and PLT) variables on CD34+ CE.
Correlation of clinical
Time frame: September 2023 - December 2023
* Correlation of clinical (age, sex, type of donor, diagnosis, recent RBC transfusion) and biochemical variables (pre-LP values of Ht, Hb, WBC and PLT) with an adequate (≥60%) CD34+ CE. * Correlation of pre-LP Ht levels and recent (≤ 60 days) RBC transfusion with CD34+ CE, especially in the autologous setting. * AUROC (Area Under the ROC Curve) of a pre-LP model based on clinical parameters aimed at predicting an adequate (≥60%) CD34+ CE.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optimize PBSC Harvest Through Automated Buffy Coat, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measured by statistical correlation (time frame: September 2023 - December 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.