An interventional study of Closed PBSC collection with reduced gas-phase oxygen exposure in Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency and Graft Function, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Not applicable, Interventional, and Treatment
This study aims to establish a closed PBSC collection procedure with reduced gas-phase oxygen exposure and to verify its impact on graft functional quality and clinical engraftment efficiency. To evaluate whether an apheresis procedure involving adequate priming with sterile saline to eliminate gas-phase air, followed by collection into a closed collection bag without gas-phase air exposure, creates a relatively low-oxygen collection environment, and to explore its effects on CD34⁺ HSPC function and early engraftment kinetics after transplantation.
Participants will: Be prospectively and consecutively enrolled. The experimental procedure involves adequate priming of the apheresis circuit and collection bag with sterile saline, elimination of visible gas-phase air, followed by closed PBSC collection. Donors in the control group will undergo the center's previous standard PBSC collection procedure.
The pO₂ of the collection product will serve as the core indicator for process validation. CD34⁺ HSPC functional indicators will also be assessed, and recipient engraftment kinetics will be followed up.
1,248 studies on the registry are indexed under Hypoxia; 239 are open to participants now.
This study's planned enrollment of 240 is above the median of 45 across 864 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 407 studies on the registry; 300 are open to participants now.
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Exclusion Criteria:
Donors with severe organ dysfunction or other conditions considered unsuitable for peripheral blood stem cell (PBSC) mobilization and apheresis, including any of the following:
Procedure: Closed PBSC collection with reduced gas-phase oxygen exposure
Participants will undergo closed PBSC collection after adequate priming of the apheresis circuit and collection bag with sterile saline and elimination of visible gas-phase air. Donors in the control group will undergo the center's previous standard PBSC collection procedure.
Time to Neutrophil Engraftment
Time from transplant infusion to the first day of absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L maintained for 3 consecutive days in recipients receiving PBSC products collected using a closed apheresis procedure without gas-phase air exposure.
Time frame: Up to Day 30 post-transplant
pO₂ of PBSC Collection Product
pO₂ level in PBSC collection products collected using a closed apheresis procedure without gas-phase air exposure.
Time frame: Immediately after PBSC collection
ROS Levels in CD34⁺ Cells
ROS levels in CD34⁺ hematopoietic stem and progenitor cells (HSPCs) collected using a closed apheresis procedure without gas-phase air exposure.
Time frame: Day 0 (at collection)
CD34⁺ HSPC Viability
Percentage of viable CD34⁺ hematopoietic stem and progenitor cells (HSPCs) in PBSC products collected using a closed apheresis procedure without gas-phase air exposure.
Time frame: Day 0 (at collection)
CFU Formation Capacity of CD34⁺ HSPCs
Colony-forming unit (CFU) formation capacity of CD34⁺ hematopoietic stem and progenitor cells (HSPCs) in PBSC products collected using a closed apheresis procedure without gas-phase air exposure.
Time frame: Day 0 (at collection)
Correlation Between Collection Product pO₂ and Time to ANC Engraftment
Correlation coefficient between pO₂ level in PBSC collection products and time to absolute neutrophil count (ANC) engraftment in recipients after transplant.
Time frame: Up to Day 100 post-transplant
Correlation Between Collection Product pO₂ and Time to PLT Engraftment
Correlation coefficient between pO₂ level in PBSC collection products and time to platelet (PLT) engraftment in recipients after transplant.
Time frame: Up to Day 100 post-transplant
Time to Platelet Engraftment
Time from transplant infusion to the first day of platelet count ≥ 20 × 10⁹/L maintained for 7 consecutive days without platelet transfusion in recipients receiving PBSC products collected by low-oxygen closed apheresis compared with standard apheresis.
Time frame: Up to Day 100 post-transplant
Incidence of Poor Engraftment
Proportion of recipients with poor graft function (PGF), defined as cytopenia in at least two cell lineages persisting beyond Day 28 post-transplant with full donor chimerism and absence of relapse or severe GVHD, in recipients receiving PBSC products collected by low-oxygen closed apheresis compared with standard apheresis.
Time frame: Up to Day 100 post-transplant
Early Donor Chimerism
Percentage of donor-derived cells (donor chimerism) in recipients after transplant, assessed by flow cytometry.
Time frame: Up to Day 100 post-transplant
Incidence of Donor Adverse Events During and After PBSC Collection
Incidence and severity of adverse events in donors during and after PBSC collection using a closed apheresis procedure without gas-phase air exposure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Time frame: From enrollment to Day 30 post-transplant
Incidence of Recipient Adverse Events After Transplant
Incidence and severity of adverse events in recipients from transplant to Day 30 post-transplant after receiving PBSC products collected using a closed apheresis procedure without gas-phase air exposure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Time frame: From transplant to Day 30 post-transplant
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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