Healthy Volunteer Red Blood Cell Labeling Study; Not Disease FocusedPhase 1NCT07446647
Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
A Phase 1 study testing Biotinylated Red Blood Cells (BioRBC), Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC) and 51 Chromium Labeled Red Blood Cells (51Cr RBC) in people with Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused, run by Jose Cancelas at 2 sites in United States.
Trial summary
This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red blood cell (RBC) labeling method and the Biotin (BioRBC) red blood cell (RBC) labeling method to determine if biotinylated red blood cells (BioRBC) is an acceptable non radioactive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused
- What is being tested?
- Biotinylated Red Blood Cells (BioRBC), Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC) and 51 Chromium Labeled Red Blood Cells (51Cr RBC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Phase 1
- 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
- Signed and dated informed consent form.
- Age ≥18 years, of either gender.
- Normal health status (as determined by Investigators' review of medical history and physical exam).
- Qualifies for a collection; Males: height >5'1" and weight >130 lbs; Females: height >5' 5" and weight > 150 lbs.
- Complete blood count (CBC; including RBC indices MCV, MCH, MCHC, and RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, LDH, ALT, AST, total bilirubin, BUN, creatinine, and ferritin). Values outside of normal reference range if considered not to be clinically significant by the site PI may be allowed as per the site PI.
- Hemoglobin levels >13.3 g/dL and hematocrit >40% for both male and female subjects.
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- Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, and WNV virus at the time of donation.
- Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
- Meet or exceed AABB guidelines for blood donation, with the exception of travel deferrals as defined by site-specific SOPs.
Who cannot join
- Known RBC disorder that could affect RBC survival.
- Treatment with any medication known to affect RBC viability.
- Pregnant or nursing female.
- Male subjects or female subjects of childbearing potential not using medically acceptable contraceptive methods.
- Participation in another clinical study currently or within the past 28 days.
- Subjects not eligible to provide a double RBC donation per AABB guidelines for blood donation.
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- Subjects who have received blood transfusion within the previous year.
- Known pre-existing antibody specific to BioRBC.
- Subjects who have received a previous infusion of BioRBC at any time.
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
- Recruiting
Hoxworth Blood Center, University of Cincinnati
Cincinnati, Ohio, 45267
Neeta Rugg, MS, 513-558-1503, neeta.rugg@uc.edu
Sachie Ikegami, MD, PhD
- Not yet recruiting
American Red Cross
Norfolk, Virginia, 23510
Michael Wellington, MS, (757) 446-7720, michael.wellington@redcross.org
Bethany Brown, PhD
About this study
This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red blood cell (RBC) labeling method and the Biotin (BioRBC) red blood cell (RBC) labeling method to determine if biotinylated red blood cells (BioRBC) is an acceptable non radioactive alternative to 51 chromium (51Cr) radiolabeling for regulatory pharmacokinetic studies of red blood cell products.
Read the detailed description
This is a Phase 1, randomized, controlled, autologous transfusion study in healthy adult volunteers designed to compare biotinylated red blood cells (BioRBC) with 51 chromium (51Cr)-labeled red blood cells for the assessment of red blood cell (RBC) recovery and survival after 42 days of storage, with and without irradiation at Day 0.
Both 51Cr and biotin labeling have been used to measure autologous RBC recovery and survival, but biotin has not yet been accepted by the U.S. Food and Drug Administration (FDA) as a method to determine 24 hour post transfusion recovery and long term survival after storage.
Study procedures include screening, blood samples, testing, labeling and transfusion.
It is expected that about 20 people will take part in this research study.
- Being tested
- Biotinylated Red Blood Cells (BioRBC), Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC), 51 Chromium Labeled Red Blood Cells (51Cr RBC), Technetium 99m Labeled Red Blood Cells (99mTc RBC)
- Keywords
- Healthy volunteers, Red blood cell labeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotinylated Red Blood Cells (BioRBC)Biological
Also called BioRBC, Biotin labeled red blood cells
Intravenous infusion
Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)Biological
Intravenous infusion
51 Chromium Labeled Red Blood Cells (51Cr RBC)Biological
Intravenous infusion
Technetium 99m Labeled Red Blood Cells (99mTc RBC)Biological
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Unirradiated Red Blood Cells | Experimental | Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized.
Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs). Receives: Biological: Biotinylated Red Blood Cells (BioRBC); Biological: 51 Chromium Labeled Red Blood Cells (51Cr RBC); Biological: Technetium 99m Labeled Red Blood Cells (99mTc RBC) |
| Gamma Irradiated Red Blood Cells | Experimental | Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized.
Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs). Receives: Biological: Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC); Biological: 51 Chromium Labeled Red Blood Cells (51Cr RBC); Biological: Technetium 99m Labeled Red Blood Cells (99mTc RBC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Percentage of infused autologous red blood cells (RBC) remaining in circulation 24 hours after transfusion
Measured: Day 1 after completion of autologous RBC infusion (Day 43 of the study)
Lifespan of of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Survival of autologous irradiated RBC expressed as days of RBC present in blood until they disappear from circulation
Measured: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).
Secondary outcomes (4)
T50 of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Lifespan of autologous irradiated RBC, expressed as Median lifespan (T50; time in days for 50% of labeled red cells remain in circulation)
Measured: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).
Area under the curve (AUC) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Area under the curve of autologous irradiated RBC, expressed as an integrated area of the parameter time (days) x percentage of remaining cells in circulation
Measured: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).
Incidence of Adverse Events and Serious Adverse Events Following Infusion of Biotinylated and Irradiated Biotinylated Red Blood Cells
Number and proportion of subjects experiencing adverse events (AEs) and serious adverse events (SAEs) with specific attention to:
- Infusion reactions (e.g., fever, chills, rash, hypotension), Suspected transfusion related sepsis, Events meeting protocol defined stopping rules (e.g., hemolysis with anti BioRBC antibody), and Any AE judged possibly, probably, or definitely related to infusion of BioRBC or irradiated BioRBC.
Measured: From Day 42 (infusion day) through Day 154 (approximately 16 weeks post transfusion)
Incidence of Antibodies Against Biotinylated Red Blood Cells After Infusion of BioRBC
Proportion of subjects who develop detectable antibodies specific to biotinylated RBC (anti BioRBC) following infusion of BioRBC
Measured: From screening (up to 28 days before donation) through Day 112 post infusion (day 154 after red blood cell collection); extended follow up annually if anti BioRBC is detected until it disappears from circulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer Red Blood Cell Labeling Study; Not Disease FocusedStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Cancelas
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor-investigator, Jose Cancelas, Dana-Farber Cancer Institute
- Investigators
- Jose A Cancelas-Perez, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446647
- Sponsor's protocol ID
- 25-620
- Other IDs
- 75A50123C00052
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
- ClinicalTrials.gov ID
- NCT07446647
- Acronym / sponsor ID
- 25-620
- Keywords
- Healthy volunteers, Red blood cell labeling
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jose CancelasUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 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 research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red blood cell (RBC) labeling method and the Biotin (BioRBC) red blood cell (RBC) labeling method to determine if biotinylated red blood cells (BioRBC) is an acceptable non radioactive alternative to 51 chromium (51Cr) radiolabeling for regulatory pharmacokinetic studies of red blood cell products.
Detailed description
This is a Phase 1, randomized, controlled, autologous transfusion study in healthy adult volunteers designed to compare biotinylated red blood cells (BioRBC) with 51 chromium (51Cr)-labeled red blood cells for the assessment of red blood cell (RBC) recovery and survival after 42 days of storage, with and without irradiation at Day 0.
Both 51Cr and biotin labeling have been used to measure autologous RBC recovery and survival, but biotin has not yet been accepted by the U.S. Food and Drug Administration (FDA) as a method to determine 24 hour post transfusion recovery and long term survival after storage.
Study procedures include screening, blood samples, testing, labeling and transfusion.
It is expected that about 20 people will take part in this research study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unirradiated Red Blood Cells | Experimental | Biological: Biotinylated Red Blood Cells (BioRBC), Biological: 51 Chromium Labeled Red Blood Cells (51Cr RBC), Biological: Technetium 99m Labeled Red Blood Cells (99mTc RBC)Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized. Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs). |
| Gamma Irradiated Red Blood Cells | Experimental | Biological: Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC), Biological: 51 Chromium Labeled Red Blood Cells (51Cr RBC), Biological: Technetium 99m Labeled Red Blood Cells (99mTc RBC)Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized. Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent form.
Key exclusion criteria (9 listed)
- Known RBC disorder that could affect RBC survival.
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 |
|---|---|---|
| Biotinylated Red Blood Cells (BioRBC)Also: BioRBC, Biotin labeled red blood cellsIntravenous infusion | Biological | Unirradiated Red Blood Cells |
| Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)Intravenous infusion | Biological | Gamma Irradiated Red Blood Cells |
| 51 Chromium Labeled Red Blood Cells (51Cr RBC)Intravenous infusion | Biological | Gamma Irradiated Red Blood Cells, Unirradiated Red Blood Cells |
| Technetium 99m Labeled Red Blood Cells (99mTc RBC)Intravenous infusion | Biological | Gamma Irradiated Red Blood Cells, Unirradiated Red Blood Cells |
Primary outcome
24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Time frame: Day 1 after completion of autologous RBC infusion (Day 43 of the study)
Percentage of infused autologous red blood cells (RBC) remaining in circulation 24 hours after transfusion
Lifespan of of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Time frame: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).
Survival of autologous irradiated RBC expressed as days of RBC present in blood until they disappear from circulation
4 secondary outcomes
T50 of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Time frame: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).
Area under the curve (AUC) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells
Time frame: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).
Incidence of Adverse Events and Serious Adverse Events Following Infusion of Biotinylated and Irradiated Biotinylated Red Blood Cells
Time frame: From Day 42 (infusion day) through Day 154 (approximately 16 weeks post transfusion)
Incidence of Antibodies Against Biotinylated Red Blood Cells After Infusion of BioRBC
Time frame: From screening (up to 28 days before donation) through Day 112 post infusion (day 154 after red blood cell collection); extended follow up annually if anti BioRBC is detected until it disappears from circulation.
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 16 Apr 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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.
Jose A Cancelas-Perez, MD, PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biotinylated Red Blood Cells (BioRBC), Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC) and 51 Chromium Labeled Red Blood Cells (51Cr RBC) in people with Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused, run by Jose Cancelas 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 9 inclusion and 9 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 16 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jose A Cancelas-Perez, MD, PhD (617-632-3446, jose_cancelas-perez@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells (time frame: Day 1 after completion of autologous RBC infusion (Day 43 of the study)). The study lists 2 primary outcomes in all. 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 16 Apr 2026.