Healthy SubjectsPhase 2NCT07015437
A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
A Phase 2 study testing INTERCEPT Blood System for RBCs and Infusion of autologous radiolabeled RBCs in people with Healthy Subjects, run by Cerus Corporation at 2 sites in United States.
Trial summary
The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- INTERCEPT Blood System for RBCs and Infusion of autologous radiolabeled RBCs
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2025to 13 Feb 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.
- Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with the following exceptions:
- Meeting allogeneic deferral criteria due to travel, tattoos/piercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion.
- Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.
- Signed and dated informed consent form
Who cannot join
- History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease
- History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait)
- Positive DAT or IAT at study entry
- Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
- Treatment with any medication known to affect RBC viability
- Pregnant or nursing females
Show all 12Show fewer
- Participation in another interventional clinical study currently or has received an investigational drug within the past 28 days
- Less than three months from receiving an infusion of a radiolabeled blood component.
- Reenrollment in the same treatment group for which the subject previously contributed recovery and survival data in this study.
- Non study blood component donation throughout the study
- Preexisting antibody specific to INTERCEPT RBCs
- History of known hypersensitivity to chromium or technetium
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Hoxworth Blood Center
Cincinnati, Ohio, 45267
Neeta Rugg
- Recruiting
American Red Cross Research Laboratory
Norfolk, Virginia, 23510
Bethany Brown, Ph.D., MSCS
About this study
Official title: A Randomized, Controlled, Single-Blind, 2-Arm Parallel Study to Assess the Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.
Read the detailed description
Study Design
This trial is designed as a prospective, randomized, controlled, single-blind (subject blinded), 2-arm parallel study to evaluate 24-hour post-infusion recovery and lifespan of 35-day-old autologous RBCs prepared with the INTERCEPT Blood System for RBCs with AS-1. Each subject will be infused with an aliquot of autologous radiolabeled INTERCEPT-treated (Test) or untreated (Control) AS-1 RBCs. During the study period each study subject will donate a whole blood (WB) component which will be processed to produce a leukocyte reduced AS-1 RBC component. Depending on the randomization assignment of the subject (Test or Control) the RBCs in AS-1 will be processed as a Test component (either within 24 hours or 25-48 hours of collection, depending on randomization) or Control component. On Day 35, an aliquot (10-30 mL) of study RBCs will be aseptically removed from the Test or Control RBC component and radiolabeled with 51Cr for assessment of recovery and lifespan.
On Day 35, the same healthy subjects will return to the site and provide a fresh sample of heparinized blood (approximately 10 mL), the fresh autologous RBCs from this sample will be radiolabeled with 99mTc for measurement of blood volume.
The 51Cr (Test or Control) and 99mTc (fresh RBCs) radiolabeled samples (approximately 10-30 mL) will be simultaneously infused into the subject. To measure RBC recovery and blood volume, subject blood samples will be collected at the following time points after completion of the infusion: approximately 5, 7.5, 10, 12.5, 15, 20, and 30 minutes (Day 35) and at 24 ±4 hours (Day 36). To measure the RBC lifespan post infusion, additional subject blood samples will be collected. 51Cr activity will be measured at approximately 48 hours (Day 37), 72 hours (Day 38), 7 days (Day 42) post-infusion, and then weekly through 35 days post-infusion (approximately Days 49, 56, 64, and 70) for Test and Control subjects. For Test subjects, as an additional measure of circulating INTERCEPT RBCs, the proportion of acridine positive RBCs and level of acridine on Test RBCs will be evaluated. Post-infusion RBC samples will be frozen at approximately 30 minutes on Day 35 and on Days 36, 37, 38, 42, 49, 56, 64, 70, and 90.
Subjects will be monitored for adverse events (serious and non-serious) for 24 hours following the WB donation and approximately 24 hours following infusion of study RBCs. Only serious and treatment emergent adverse events, including transfusion reactions, will be assessed at subsequent post-infusion visits.
Samples for in vitro RBC testing (see in vitro evaluation of RBCs below) will be collected from RBC components at input, post-INTERCEPT (Test only), and after 35 days of storage (Test and Control).
- Conditions
- Healthy Subjects
- Being tested
- INTERCEPT Blood System for RBCs, Infusion of autologous radiolabeled RBCs
- Keywords
- INTERCEPT, Red Blood Cells, RBC, Pathogen Inactivation, Pathogen reduction, Cerus, Survival, Radiolabel, Autologous, Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERCEPT Blood System for RBCsDevice
RBCs treated with the INTERCEPT Blood System for RBCs
Infusion of autologous radiolabeled RBCsOther
Subject will receive a single intravenous infusion of approximately 10 to 30 mL of autologous Day 35 51Cr radiolabeled RBCs and fresh 99mTc RBCs.
| Study group | Role | What they receive |
|---|---|---|
| Test RBCs will be prepared with the INTERCEPT Blood System for RBCs | Experimental | One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Test treatment arm for preparation of the Test RBCs. The Test RBCs will be prepared with the INTERCEPT Blood System for RBCs with AS-1, within 24 hours or 25 to 48 hours post collection (depending on randomization assignment) and stored at 1°C to 6°C for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 autologous 51Cr radiolabeled Test RBCs. Receives: Device: INTERCEPT Blood System for RBCs; Other: Infusion of autologous radiolabeled RBCs |
| Control RBC components will be prepared according to the site standard operating procedures | Experimental | One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Control treatment arm for preparation of the Control RBCs in AS-1. The Control RBC components will be prepared and stored at 1°C to 6°C, according to the site standard operating procedures, for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 51Cr autologous radiolabeled Control RBCs. Receives: Other: Infusion of autologous radiolabeled RBCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion
The 24-hour recovery will be calculated using the subject's blood volume derived from infusion of 99mTc-labeled fresh RBCs.
Measured: Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion
Secondary outcomes (3)
. The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion
The 24-hour recovery will be calculated using the subject's blood volume derived the subject's height and weight.
Measured: Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion
. The number of days 51Cr-labeled Test/INTERCEPT or Control RBCs remain in circulation up to post-infusion
The value will be derived by measurement of detectable 51Cr- labeled RBC with time
Measured: Over 35 days post infusion
Hemolysis (<1%)
Proportion of RBC component hemolysis on Day 35 (<1%).
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start19 Sep 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion13 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015437
- Sponsor's protocol ID
- CLI 00182
- Other IDs
- HHSO100201600009C
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Single-Blind, 2-Arm Parallel Study to Assess the Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
- ClinicalTrials.gov ID
- NCT07015437
- Acronym / sponsor ID
- CLI 00182
- Conditions
- Healthy Subjects
- Keywords
- INTERCEPT, Red Blood Cells, RBC, Pathogen Inactivation, Pathogen reduction, Cerus, Survival, Radiolabel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 13 Feb 2027 (estimated)
- First posted
- 11 Jun 2025 (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.
The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.
Detailed description
Study Design
This trial is designed as a prospective, randomized, controlled, single-blind (subject blinded), 2-arm parallel study to evaluate 24-hour post-infusion recovery and lifespan of 35-day-old autologous RBCs prepared with the INTERCEPT Blood System for RBCs with AS-1. Each subject will be infused with an aliquot of autologous radiolabeled INTERCEPT-treated (Test) or untreated (Control) AS-1 RBCs. During the study period each study subject will donate a whole blood (WB) component which will be processed to produce a leukocyte reduced AS-1 RBC component. Depending on the randomization assignment of the subject (Test or Control) the RBCs in AS-1 will be processed as a Test component (either within 24 hours or 25-48 hours of collection, depending on randomization) or Control component. On Day 35, an aliquot (10-30 mL) of study RBCs will be aseptically removed from the Test or Control RBC component and radiolabeled with 51Cr for assessment of recovery and lifespan.
On Day 35, the same healthy subjects will return to the site and provide a fresh sample of heparinized blood (approximately 10 mL), the fresh autologous RBCs from this sample will be radiolabeled with 99mTc for measurement of blood volume.
The 51Cr (Test or Control) and 99mTc (fresh RBCs) radiolabeled samples (approximately 10-30 mL) will be simultaneously infused into the subject. To measure RBC recovery and blood volume, subject blood samples will be collected at the following time points after completion of the infusion: approximately 5, 7.5, 10, 12.5, 15, 20, and 30 minutes (Day 35) and at 24 ±4 hours (Day 36). To measure the RBC lifespan post infusion, additional subject blood samples will be collected. 51Cr activity will be measured at approximately 48 hours (Day 37), 72 hours (Day 38), 7 days (Day 42) post-infusion, and then weekly through 35 days post-infusion (approximately Days 49, 56, 64, and 70) for Test and Control subjects. For Test subjects, as an additional measure of circulating INTERCEPT RBCs, the proportion of acridine positive RBCs and level of acridine on Test RBCs will be evaluated. Post-infusion RBC samples will be frozen at approximately 30 minutes on Day 35 and on Days 36, 37, 38, 42, 49, 56, 64, 70, and 90.
Subjects will be monitored for adverse events (serious and non-serious) for 24 hours following the WB donation and approximately 24 hours following infusion of study RBCs. Only serious and treatment emergent adverse events, including transfusion reactions, will be assessed at subsequent post-infusion visits.
Samples for in vitro RBC testing (see in vitro evaluation of RBCs below) will be collected from RBC components at input, post-INTERCEPT (Test only), and after 35 days of storage (Test and Control).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test RBCs will be prepared with the INTERCEPT Blood System for RBCs | Experimental | Device: INTERCEPT Blood System for RBCs, Other: Infusion of autologous radiolabeled RBCsOne unit of WB (500 ±50 mL) will be collected from subjects randomized to the Test treatment arm for preparation of the Test RBCs. The Test RBCs will be prepared with the INTERCEPT Blood System for RBCs with AS-1, within 24 hours or 25 to 48 hours post collection (depending on randomization assignment) and stored at 1°C to 6°C for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 autologous 51Cr radiolabeled Test RBCs. |
| Control RBC components will be prepared according to the site standard operating procedures | Experimental | Other: Infusion of autologous radiolabeled RBCsOne unit of WB (500 ±50 mL) will be collected from subjects randomized to the Control treatment arm for preparation of the Control RBCs in AS-1. The Control RBC components will be prepared and stored at 1°C to 6°C, according to the site standard operating procedures, for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 51Cr autologous radiolabeled Control RBCs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.
- Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with the following exceptions:
- Meeting allogeneic deferral criteria due to travel, tattoos/piercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion.
- Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.
Key exclusion criteria (12 listed)
- History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease
- History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait)
- Positive DAT or IAT at study entry
- Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
- Treatment with any medication known to affect RBC viability
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 |
|---|---|---|
| INTERCEPT Blood System for RBCsRBCs treated with the INTERCEPT Blood System for RBCs | Device | Test RBCs will be prepared with the INTERCEPT Blood System for RBCs |
| Infusion of autologous radiolabeled RBCsSubject will receive a single intravenous infusion of approximately 10 to 30 mL of autologous Day 35 51Cr radiolabeled RBCs and fresh 99mTc RBCs. | Other | Control RBC components will be prepared according to the site standard operating procedures, Test RBCs will be prepared with the INTERCEPT Blood System for RBCs |
Primary outcome
The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion
Time frame: Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion
The 24-hour recovery will be calculated using the subject's blood volume derived from infusion of 99mTc-labeled fresh RBCs.
3 secondary outcomes
. The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion
Time frame: Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion
. The number of days 51Cr-labeled Test/INTERCEPT or Control RBCs remain in circulation up to post-infusion
Time frame: Over 35 days post infusion
Hemolysis (<1%)
Time frame: 35 days
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 21 Sep 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INTERCEPT Blood System for RBCs and Infusion of autologous radiolabeled RBCs in people with Healthy Subjects, run by Cerus Corporation at 2 sites in United States.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Margaret Hennig, Ph.D. (925-288-6178, mhennig@cerus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion (time frame: Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion). 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 21 Sep 2026.