Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
A Prospective Exploratory Study on the Impact of a Closed Peripheral Blood Stem Cell Collection Procedure Based on Reducing Gas-Phase Oxygen Exposure on Graft Functional Quality and Early Engraftment Kinetics in Allogeneic Hematopoietic Stem Cell Transplantation
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: erlie jiang
- Telefonní číslo: 02223608600
- E-mail: jiangerlie@ihcams.ac.cn
Studijní záloha kontaktů
- Jméno: yigeng cao
- Telefonní číslo: 18622477066
- E-mail: caoyigeng@ihcams.ac.cn
Studijní místa
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Čína, 300020
- National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Healthy donors or related/unrelated donors scheduled to undergo peripheral blood hematopoietic stem cell apheresis; if autologous collection is performed for the patient, the sample may be included in the process validation cohort as an exploratory sample.
- Donors meet current standards for hematopoietic stem cell donation and apheresis, and the investigator judges that PBSC collection can be completed.
- The corresponding recipient is scheduled to undergo allogeneic hematopoietic stem cell transplantation using PBSC as the graft source.
- Both the donor and recipient have signed informed consent; if only ex vivo testing of the collection product is performed and recipient outcome analysis is not included, informed consent may be obtained only from the donor and as required by relevant ethics requirements.
Exclusion Criteria:
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Donors with severe organ dysfunction or other conditions considered unsuitable for peripheral blood stem cell (PBSC) mobilization and apheresis, including any of the following:
- Cardiovascular dysfunction: New York Heart Association (NYHA) class III-IV heart failure, or clinically significant cardiovascular disease such as uncontrolled severe arrhythmia, unstable angina, or recent myocardial infarction.
- Pulmonary dysfunction: resting hypoxemia or severe pulmonary dysfunction that may compromise the safety of PBSC mobilization or apheresis.
- Hepatic dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN), decompensated cirrhosis, or other severe active liver disease.
- Renal dysfunction: estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m² or requirement for dialysis.
- Coagulation disorders: active bleeding or clinically significant coagulation abnormalities considered to substantially increase the risk of bleeding associated with venipuncture, central venous catheterization, or apheresis; Infection: active, uncontrolled severe infection.
- Other conditions that, in the opinion of the donor-evaluating physician, may substantially increase the risks associated with granulocyte colony-stimulating factor (G-CSF) mobilization or PBSC apheresis.
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A reliable closed collection system is not expected to be established during apheresis, or the required sampling cannot be completed.
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Research sampling of the collection product cannot be performed due to urgent clinical reasons.
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The investigator judges that participation in the study may increase unacceptable risks to the donor or recipient.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Low-Oxygen Closed PBSC Collection
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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. |
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Žádný zásah: Standard PBSC Collection
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Time to Neutrophil Engraftment
Časové okno: Up to Day 30 post-transplant
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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. |
Up to Day 30 post-transplant
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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pO₂ of PBSC Collection Product
Časové okno: Immediately after PBSC collection
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pO₂ level in PBSC collection products collected using a closed apheresis procedure without gas-phase air exposure. |
Immediately after PBSC collection
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ROS Levels in CD34⁺ Cells
Časové okno: Day 0 (at collection)
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ROS levels in CD34⁺ hematopoietic stem and progenitor cells (HSPCs) collected using a closed apheresis procedure without gas-phase air exposure. |
Day 0 (at collection)
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CD34⁺ HSPC Viability
Časové okno: Day 0 (at collection)
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Percentage of viable CD34⁺ hematopoietic stem and progenitor cells (HSPCs) in PBSC products collected using a closed apheresis procedure without gas-phase air exposure. |
Day 0 (at collection)
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CFU Formation Capacity of CD34⁺ HSPCs
Časové okno: Day 0 (at collection)
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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. |
Day 0 (at collection)
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Correlation Between Collection Product pO₂ and Time to ANC Engraftment
Časové okno: Up to Day 100 post-transplant
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Correlation coefficient between pO₂ level in PBSC collection products and time to absolute neutrophil count (ANC) engraftment in recipients after transplant. |
Up to Day 100 post-transplant
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Correlation Between Collection Product pO₂ and Time to PLT Engraftment
Časové okno: Up to Day 100 post-transplant
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Correlation coefficient between pO₂ level in PBSC collection products and time to platelet (PLT) engraftment in recipients after transplant. |
Up to Day 100 post-transplant
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Time to Platelet Engraftment
Časové okno: Up to Day 100 post-transplant
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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. |
Up to Day 100 post-transplant
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Incidence of Poor Engraftment
Časové okno: Up to Day 100 post-transplant
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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. |
Up to Day 100 post-transplant
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Early Donor Chimerism
Časové okno: Up to Day 100 post-transplant
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Percentage of donor-derived cells (donor chimerism) in recipients after transplant, assessed by flow cytometry. |
Up to Day 100 post-transplant
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Incidence of Donor Adverse Events During and After PBSC Collection
Časové okno: From enrollment to Day 30 post-transplant
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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. |
From enrollment to Day 30 post-transplant
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Incidence of Recipient Adverse Events After Transplant
Časové okno: From transplant to Day 30 post-transplant
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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. |
From transplant to Day 30 post-transplant
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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