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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: erlie jiang
- Numéro de téléphone: 02223608600
- E-mail: jiangerlie@ihcams.ac.cn
Sauvegarde des contacts de l'étude
- Nom: yigeng cao
- Numéro de téléphone: 18622477066
- E-mail: caoyigeng@ihcams.ac.cn
Lieux d'étude
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chine, 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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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: Standard PBSC Collection
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Time to Neutrophil Engraftment
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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pO₂ of PBSC Collection Product
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIT2026109
Informations sur les médicaments et les dispositifs, documents d'étude
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