Red Blood Cell Labeling Methods for Blood Donation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods for labeling red blood cells (RBCs) to determine their survival duration in the body. The goal is to assess whether a non-radioactive method using biotin (a type of vitamin) can match the effectiveness of the traditional radioactive method. Researchers are testing several types of labeled RBCs, including 51 Chromium Labeled Red Blood Cells (51Cr RBC), Biotinylated Red Blood Cells (BioRBC), Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC), and Technetium 99m Labeled Red Blood Cells (99mTc RBC), to compare their effectiveness. Healthy adults who meet blood donation requirements and have no known issues with red blood cells may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical advancements.
Will I have to stop taking my current medications?
If you are taking any medication that affects red blood cell health, you will need to stop taking it to participate in this trial.
What prior data suggests that these red blood cell labeling methods are safe?
In a previous study, researchers safely used a type of red blood cell test involving a small amount of radiation to diagnose blood-related conditions. These tests have been employed in medical settings for a long time without major issues.
Research has shown that labeling red blood cells with biotin, a vitamin, is also safe. Studies have found no harmful effects from using biotin-labeled red blood cells in people.
For irradiated biotin-labeled red blood cells, the process of using radiation to prepare blood products is generally safe. Studies have not specifically identified harmful effects from using these cells.
Technetium 99m-labeled red blood cells are frequently used for imaging tests and are considered safe. They involve a small amount of radioactive material, which the body eliminates quickly. Studies have not identified any major safety concerns.
Overall, these methods have maintained a good safety record in medical settings. However, as this is an early-phase trial, the primary goal is to monitor for any unexpected safety issues.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative methods for labeling red blood cells, which could improve blood donation processes. Unlike standard labeling methods, this trial investigates biotinylation and the use of radioactive markers like 51 Chromium and Technetium 99m. These methods may provide more precise tracking of blood cells, potentially enhancing the safety and efficiency of blood transfusions. By better understanding how these labeling techniques impact red blood cells, researchers hope to optimize blood storage and transfusion protocols, ultimately improving patient outcomes.
What evidence suggests that this trial's red blood cell labeling methods could be effective?
Research has shown that 51 Chromium (51Cr) labeled red blood cells have been used for many years to determine the lifespan and recovery of red blood cells after a transfusion. This method clarifies how long red blood cells remain in the body, which is crucial for diagnosis. In this trial, participants may receive 51Cr labeled red blood cells. Biotinylated red blood cells (BioRBC), another option in this trial, provide a non-radioactive alternative. Studies have found that BioRBCs can safely and effectively measure the lifespan of red blood cells in the body. Technetium 99m (99mTc) labeled red blood cells, also under study in this trial, are known for their high efficiency in labeling, which aids in certain medical imaging tests. Each method effectively tracks red blood cells, offering different advantages based on medical needs.46789
Who Is on the Research Team?
Jose A Cancelas-Perez, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for healthy adults (18+), meeting blood donation standards, with normal lab results and no major infections. Participants must not have red blood cell disorders, be pregnant or nursing, or have had a recent transfusion. Both men and women must use reliable birth control during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Labeling and Transfusion
Participants undergo labeling of red blood cells with biotin and 51Cr, followed by autologous transfusion
Post-transfusion Monitoring
Participants are monitored for 24-hour post-transfusion recovery and lifespan of labeled RBCs
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and antibody development
What Are the Treatments Tested in This Trial?
Interventions
- 51 Chromium Labeled Red Blood Cells (51Cr RBC)
- Biotinylated Red Blood Cells (BioRBC)
- Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)
- Technetium 99m Labeled Red Blood Cells (99mTc RBC)
Trial Overview
The study compares different ways of labeling donated red blood cells—using biotin, technetium-99m, irradiation plus biotin, or chromium-51—to see how long they survive in the body after being given back to the donor. The goal is to find out if non-radioactive methods work as well as radioactive ones.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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).
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jose Cancelas
Lead Sponsor
Department of Health and Human Services
Collaborator
Citations
Measuring Post-transfusion Recovery and Survival of Red ...
Over the last 50 years, most of the transfusion recovery data were generated by chromium-51 (51Cr)-labeling studies and were predominantly performed to validate ...
51Cr Red Blood Cells in the Study of Hematologic Disease
The red blood cell survival study evaluates the lifespan of the cell in patients with suspected hemolytic anemia and splenic sequestration, ...
Clinical Evaluation of a 51 Cr-Labeled Red Blood Cell ...
The results of the studies suggest that for patients with blood compatibility problems, normal red blood cell survival values at 1 hour do not exclude the ...
4.
withpower.com
withpower.com/trial/phase-1-healthy-volunteer-red-blood-cell-labeling-study-not-disease-focused-3-2026-46fe2Red Blood Cell Labeling Methods for Blood Donation
This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red ...
5.
ctv.veeva.com
ctv.veeva.com/study/comparative-analysis-of-biotinylated-irradiated-and-51-chromium-radiolabeled-red-blood-cells-for-anComparative Analysis of Biotinylated, Irradiated and 51 ...
This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red ...
51Cr Red Blood Cells in the Study of Hematologic Disease
51 Cr-labeled red blood cells-an important diagnostic element in patients suspected of having polycythemia vera, congestive heart failure, hypertension, shock, ...
Measuring Post-transfusion Recovery and Survival of Red ...
Here, 15–30 ml of RBCs from a donor is labeled with 51Cr (14) and injected to the recipient (most of the time the donor himself) (15–31). RBC recovery is ...
Advancing in vivo assessment of red blood cell transfusions
This article reviews existing in vivo techniques, like chromium-51 labelling and biotinylation, for determining the circulation and survival of RBCs.
9.
ctv.veeva.com
ctv.veeva.com/study/recovery-and-lifespan-of-red-blood-cells-from-pathogen-reduced-stored-blood-unitsRecovery and Lifespan of Red Blood Cells From Pathogen ...
Mean lifespan of autologous RBC stored for 35 days and then labeled with either 51Cr or biotin · Median lifespan (T50) of autologous RBC stored ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.