Biotin-Acridine Red Cell Exchange Kinetics

NCT07155031 | Withdrawn Phase 2 DMC FDA Device

• 1 other identifier: CLI 00185
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to describe the recovery and survival of pathogen-reduced (PR) red blood cells (RBCs) prepared and stored with the INTERCEPT Blood System for RBCs® (hereafter referred to as INTERCEPT RBCs) in patients with sickle cell disease (SCD) undergoing red cell exchange (RCE) therapy, utilizing flow cytometry for biotin and acridine RBC surface markers.

Conditions

Sickle Cell Disease

Keywords

pathogen reduction; sickle cell disease; red cell exchange; biotin

Outcome Measures

Primary Outcomes (4)

• Recovery

  The volume of distribution and 24-hour post transfusion recovery (PTR24) of the INTERCEPT RBC units

  24 hour

• Correlation between the biotin and acridine markers

  Correlation between the biotin and acridine markers for determining the number of circulating INTERCEPT RBCs

  6 months

• Survival

  Comparison of Pre-PR and INTERCEPT RBC PTR24, and survival over the duration of the study with intervening RCE procedures

  6 months

• Acridine loss

  Kinetics of acridine loss from the INTERCEPT RBC surface

  6 months

Secondary Outcomes (2)

• Adverse Events

  6 months

• Treatment emergent antibodies

  6 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

All subjects enrolled in CLI00185 will participate in the intervention arm which includes transfusion of a single pathogen reduced red blood cell unit in conjunction with two sequential red cell exchange episodes (as prescribed by subjects attending physician). Subjects will also receive aliquots of biotin labeled red blood cells during the first of the two red cell exchange episodes.

Device: Pathogen reduced red blood cells

Interventions

Pathogen reduced red blood cells DEVICE

pathogen reduced red blood cells with biotin labeled aliquots will be transfused as part of routine care red cell exchange procedures

Also known as: Biotin

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• homozygous sickle cell disease (HbSS) or Hemoglobin S-β-thalassemia (HbSβ0) SCD
• Receiving RCE for ≥3 months prior to enrollment and scheduled to undergo at least 4 sequential RCE episodes during the period of enrollment in the study

You may not qualify if:

• Anticipated cessation of RBC transfusion therapy in the next ≤2 months
• Planned stem cell transplant or gene therapy in the next 6 months
• Delayed hemolytic transfusion reaction in the past 3 months
• History of hyperhemolysis syndrome at any time
• Consuming high-dose biotin or raw egg supplements
• Current pregnancy
• Antibody specific to INTERCEPT RBCs or biotinylated red blood cells (BioRBCs) at baseline
• Patients with RBC alloantibodies that make it difficult to provide antigen matched blood.

Sponsors & Collaborators

• Cerus Corporation: lead

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Phase 2, non-randomized, open-label, single arm, single center study

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04