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Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT

6 november 2026 uppdaterad av: Institute of Hematology & Blood Diseases Hospital, China

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

240

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kina
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300020
        • National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. 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.
  2. Donors meet current standards for hematopoietic stem cell donation and apheresis, and the investigator judges that PBSC collection can be completed.
  3. The corresponding recipient is scheduled to undergo allogeneic hematopoietic stem cell transplantation using PBSC as the graft source.
  4. 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:

  1. Donors with severe organ dysfunction or other conditions considered unsuitable for peripheral blood stem cell (PBSC) mobilization and apheresis, including any of the following:

    1. 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.
    2. Pulmonary dysfunction: resting hypoxemia or severe pulmonary dysfunction that may compromise the safety of PBSC mobilization or apheresis.
    3. Hepatic dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN), decompensated cirrhosis, or other severe active liver disease.
    4. Renal dysfunction: estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m² or requirement for dialysis.
    5. 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.
    6. 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.

  2. A reliable closed collection system is not expected to be established during apheresis, or the required sampling cannot be completed.

  3. Research sampling of the collection product cannot be performed due to urgent clinical reasons.

  4. The investigator judges that participation in the study may increase unacceptable risks to the donor or recipient.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Low-Oxygen Closed PBSC Collection
Procedur: 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.
Inget ingripande: Standard PBSC Collection

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Neutrophil Engraftment
Tidsram: Up to Day 30 post-transplant

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
pO₂ of PBSC Collection Product
Tidsram: Immediately after PBSC collection

pO₂ level in PBSC collection products collected using a closed apheresis procedure without gas-phase air exposure.
Immediately after PBSC collection
ROS Levels in CD34⁺ Cells
Tidsram: Day 0 (at collection)

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)
CD34⁺ HSPC Viability
Tidsram: Day 0 (at collection)

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)
CFU Formation Capacity of CD34⁺ HSPCs
Tidsram: Day 0 (at collection)

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)
Correlation Between Collection Product pO₂ and Time to ANC Engraftment
Tidsram: Up to Day 100 post-transplant

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
Correlation Between Collection Product pO₂ and Time to PLT Engraftment
Tidsram: Up to Day 100 post-transplant

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
Time to Platelet Engraftment
Tidsram: Up to Day 100 post-transplant

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
Incidence of Poor Engraftment
Tidsram: Up to Day 100 post-transplant

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
Early Donor Chimerism
Tidsram: Up to Day 100 post-transplant

Percentage of donor-derived cells (donor chimerism) in recipients after transplant, assessed by flow cytometry.
Up to Day 100 post-transplant
Incidence of Donor Adverse Events During and After PBSC Collection
Tidsram: From enrollment to Day 30 post-transplant

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
Incidence of Recipient Adverse Events After Transplant
Tidsram: From transplant to Day 30 post-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.
From transplant to Day 30 post-transplant

Samarbetspartners och utredare

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Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

30 oktober 2029

Avslutad studie (Beräknad)

30 oktober 2029

Studieregistreringsdatum

Först inskickad

24 september 2026

Först inskickad som uppfyllde QC-kriterierna

23 oktober 2026

Första postat (Faktisk)

29 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 november 2026

Mer information

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Andra studie-ID-nummer

  • IIT2026109

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