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Biotin for Platelet Studies in Healthy Subjects

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how effectively biotin (vitamin B7) can label platelets for tracking in blood studies. Researchers add biotin and a small amount of radioactive material to platelets to track them once reintroduced into the bloodstream. Generally healthy individuals who meet specific blood donation guidelines are suitable for this trial. Participants should not have taken aspirin or similar medications recently and must agree to use birth control during the study. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to experience this innovative approach.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications. Specifically, you should not take aspirin-containing medications within 7 days or platelet-inhibiting medications within 14 days before platelet collection.

What prior data suggests that this method is safe for labeling platelets?

Research has shown that using biotin-labeled platelets in humans is safe, particularly with small amounts of biotin. Biotin, or vitamin B7, is generally safe and non-toxic, even in large doses. However, biotin can interfere with some lab tests, potentially leading to incorrect results. Despite this, labeling platelets with biotin offers a promising method for tracking them in the body. Overall, current evidence suggests that biotin-labeled platelets are well-tolerated in humans, with measures in place to minimize any impact on lab tests.12345

Why are researchers excited about this trial?

Researchers are excited about biotin-labeled platelets because they offer a novel way to study platelet behavior in the body. Unlike traditional methods that rely on indirect measurements, this approach uses biotin to directly label and track platelets, providing more precise data on how platelets function. This innovative method could lead to better understanding and treatment of platelet-related conditions, as it allows scientists to observe platelet activity in real-time with greater accuracy.

What evidence suggests that biotin-labeled platelets are effective for platelet tracking?

This trial will study biotin-labeled platelets in healthy subjects. Studies have shown that biotin, or vitamin B7, can mark platelets, which are small blood cells that aid in clotting. One study found that 98.4% of platelets were successfully marked with biotin, meeting blood bank standards. Biotin-marked platelets enable researchers to track and study platelet lifespan and recovery post-transfusion. This method is promising because it offers insights into platelet function without altering their natural behavior. Overall, using biotin is considered an effective alternative to older methods, such as radioactive materials.12367

Are You a Good Fit for This Trial?

This trial is for healthy adults who qualify as blood donors, have normal lab results, test negative for HIV and hepatitis B/C, and agree to use birth control during the study.

Inclusion Criteria

I am healthy, have normal lab results, and test negative for HIV and hepatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Platelet Collection and Storage

Healthy volunteers donate a platelet unit, which is stored for 3 days before radiolabeling

3 days
1 visit (in-person)

Radiolabeling and Infusion

Radiolabeled and biotinylated platelets are infused back to the donor, followed by blood sample collection over 12 days

12 days
Multiple visits (in-person) over 12 days

Follow-up

Participants are monitored for platelet count, biotin, and antibody detection over a 6-month period

6 months
Visits at 1, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Biotin labeled platelets

Trial Overview

The study tests if vitamin B7 (biotin) can be used to label platelets for tracking their survival in the body. Participants donate platelets, which are labeled with biotin and a small amount of radioactive material before being transfused back into them.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Biotin labeled plateletsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bloodworks

Lead Sponsor

Trials
12
Recruited
630+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38757806/

Biotin labeling allows for post-transfusion functional ... - PubMed

Results: The activation profile of biotinylated platelets was comparable to sham-RL platelets before transfusion except for significantly less α ...

Biotinylated Platelets: A Promising Labeling Technique?

In vivo research with biotin labeled platelets can be conducted to improve the quality of platelet products and study platelet recovery, survival, and post- ...

The Primary Purpose of This Study is to Determine if Biotin ...

The primary purpose of this study is to determine if Biotin, vitamin B7 is an effective way to label platelets in survival and recovery studies.

Biotin for Platelet Studies in Healthy Subjects

The primary purpose of this study is to determine if Biotin, vitamin B7 is an effective way to label platelets in survival and recovery studies.

Biotinylation of platelets for transfusion purposes a novel ...

After biotinylation, 98.4% ± 0.9% of PLTs were labeled. PLT counts, pH, and “swirling” were within the range accepted by the Dutch blood bank for standard PLT ...

Biotinylation of human platelets is compatible with ...

Biotin-labeled platelets can effectively enable investigation of the effects of PIT and storage temperature for clinical studies.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/1329258/

Labeling of Platelet Surface Glycoproteins With Biotin ...

We describe a non-radioactive method for the labeling of platelet surface proteins, consisting of platelet protein biotinylation by means of ...