Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)NCT07904234
Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
A study testing Closed PBSC collection with reduced gas-phase oxygen exposure in people with Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and Oxygen Deficiency, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency, Graft Function
- What is being tested?
- Closed PBSC collection with reduced gas-phase oxygen exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- A reliable closed collection system is not expected to be established during apheresis, or the required sampling cannot be completed.
- Research sampling of the collection product cannot be performed due to urgent clinical reasons.
- The investigator judges that participation in the study may increase unacceptable risks to the donor or recipient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Tianjin, Tianjin Municipality, 300020
About this study
Official title: 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.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency, Graft Function
- Being tested
- Closed PBSC collection with reduced gas-phase oxygen exposure
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed PBSC collection with reduced gas-phase oxygen exposureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Oxygen Closed PBSC Collection | Experimental | Not described Receives: Procedure: Closed PBSC collection with reduced gas-phase oxygen exposure |
| Standard PBSC Collection | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 30 post-transplant
Secondary outcomes (11)
pO₂ of PBSC Collection Product
pO₂ level in PBSC collection products collected using a closed apheresis procedure without gas-phase air exposure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 100 post-transplant
Early Donor Chimerism
Percentage of donor-derived cells (donor chimerism) in recipients after transplant, assessed by flow cytometry.
Measured: 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.
Measured: 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.
Measured: From transplant to Day 30 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904234
- Sponsor's protocol ID
- IIT2026109
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07904234
- Acronym / sponsor ID
- IIT2026109
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency, Graft Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Oxygen Closed PBSC Collection | Experimental | Procedure: Closed PBSC collection with reduced gas-phase oxygen exposure |
| Standard PBSC Collection | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Donors with severe organ dysfunction or other conditions considered unsuitable for peripheral blood stem cell (PBSC) mobilization and apheresis, including any of the following:
- A reliable closed collection system is not expected to be established during apheresis, or the required sampling cannot be completed.
- Research sampling of the collection product cannot be performed due to urgent clinical reasons.
- The investigator judges that participation in the study may increase unacceptable risks to the donor or recipient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed PBSC collection with reduced gas-phase oxygen exposureParticipants 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. | Procedure or surgery | Low-Oxygen Closed PBSC Collection |
Primary outcome
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.
11 secondary outcomes
pO₂ of PBSC Collection Product
Time frame: Immediately after PBSC collection
ROS Levels in CD34⁺ Cells
Time frame: Day 0 (at collection)
CD34⁺ HSPC Viability
Time frame: Day 0 (at collection)
CFU Formation Capacity of CD34⁺ HSPCs
Time frame: Day 0 (at collection)
Correlation Between Collection Product pO₂ and Time to ANC Engraftment
Time frame: Up to Day 100 post-transplant
Correlation Between Collection Product pO₂ and Time to PLT Engraftment
Time frame: Up to Day 100 post-transplant
Time to Platelet Engraftment
Time frame: Up to Day 100 post-transplant
Incidence of Poor Engraftment
Time frame: Up to Day 100 post-transplant
Early Donor Chimerism
Time frame: 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 of Recipient Adverse Events After Transplant
Time frame: From transplant to Day 30 post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed PBSC collection with reduced gas-phase oxygen exposure in people with Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and Oxygen Deficiency, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact erlie jiang (02223608600, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Neutrophil Engraftment (time frame: Up to Day 30 post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.