Biological Variables Affecting CD34+ Peripheral Cells Collection Efficiency

NCT06308133 | Completed

• 1 other identifier: CD34+CE_2023
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Optimize PBSC Harvest Through Automated Buffy Coat

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  September 2023 - December 2023

Study Arms (2)

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.

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.

Other: apheresis procedure

Interventions

apheresis procedure OTHER

collection of hematopoietic stem cells carried out using the single-chamber and continuous mononuclear cell (cMNC) collection system with Spectra Optia (Terumo BCT)

Patients; Stem cells donors

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Patients affected by Acute Lymphoblastic Leukemia

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica

Milan, Milano, 20122, Italy

Location

MeSH Terms

Interventions

Blood Component Removal

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maria Cristina Mocellin

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

IT (1)