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

November 6, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-Oxygen Closed PBSC Collection
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.
No Intervention: Standard PBSC Collection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Neutrophil Engraftment
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pO₂ of PBSC Collection Product
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT2026109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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