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Biotin label for Sickle Cell Disease

Phase < 1
Waitlist Available
Led By John F Tisdale, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

Study Summary

This trial will study how long red blood cells live in people with and without sickle cell disease.

Eligible Conditions
  • Sickle Cell Disease
  • Sickle Cell Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Red Blood Cells Lifespan in Participants
Secondary outcome measures
Mean Absolute Reticulocyte Count
Mean Adult Hemoglobin Percentage
Mean Aspartate Aminotransferase Value
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sickle Cell Trait (HbAS)Experimental Treatment1 Intervention
Autologous cells will be collected in participants with Sickle Cell Trait (HbAS) and biotin-labeled ex vivo and reinfused to measure red cell survival
Group II: Sickle Cell Disease Pre-TransplantationExperimental Treatment1 Intervention
Autologous cells will be collected in participants with Sickle Cell Disease Pre-Transplantation and biotin-labeled ex vivo and reinfused to measure red cell survival
Group III: Sickle Cell Disease Post-TransplantationExperimental Treatment1 Intervention
Autologous cells will be collected in participants with Sickle Cell Disease Post-Transplantation and biotin-labeled ex vivo and reinfused to measure red cell survival
Group IV: HbAA (Healthy volunteers)Experimental Treatment1 Intervention
Autologous cells will be collected in participants with HbAA (Healthy volunteers) and biotin-labeled ex vivo and reinfused to measure red cell survival
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biotin label
2021
Completed Early Phase 1
~30

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,833 Previous Clinical Trials
47,306,474 Total Patients Enrolled
John F Tisdale, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
14 Previous Clinical Trials
1,305 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals below the age of sixty being considered for enrollment in this research?

"The requirements for joining this medical trial stipulate that participants are between 18 and 99 years old. Additionally, there are 132 clinical trials available to minors while 91 focus on those above the age of 65."

Answered by AI

What is the participant count for this experiment?

"The trial is not currently recruiting, as the latest update dates back to October 26th 2022. However, if you are seeking other studies that accept patients with anemia or sickle cell disease there are 198 active trials and 5 for Biotin label recruitment."

Answered by AI

Are there still openings available to participants in this research project?

"According to clinicaltrials.gov, the trial initially posted on April 19th 2021 is not currently accepting candidates for enrollment. However, there are 203 other studies actively seeking volunteers at this time."

Answered by AI

Who is eligible to take part in this investigation?

"This clinical trial is seeking 20 individuals, aged between 18 and 99, who are diagnosed with anemia or sickle cell disease. Other prerequisites for entry into the study include having a confirmed diagnosis of homozygous SCD (HbSS, HbSC, HbSB0), possessing sickle cell trait (HbAS) or being a healthy volunteer (HbA)."

Answered by AI

Are there any recorded instances of Biotin label being used for testing purposes?

"Currently, 5 clinical trials that assess Biotin label are ongoing - 1 of which is in its final stage. While the majority of studies for Biotin label are hosted out of Bethesda, Maryland, there exist a total of 7 sites running related research."

Answered by AI
~5 spots leftby Apr 2025