RHD Genotype Matched Red Cells for Anti-D

Last updated: May 1, 2025
Sponsor: Children's Hospital of Philadelphia
Overall Status: Completed

Phase

1

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

D+ RH genotype matched red cell units for transfusion

Clinical Study ID

NCT04156906
19-016566
R01HL147879-01
  • Ages > 8
  • All Genders

Study Summary

This is a pilot study to evaluate the feasibility and safety of providing RH genotype matched D+ Red Blood Cells (RBCs) to chronically transfused patients with sickle cell disease (SCD) who type D+ but have formed anti-D and are currently transfused with D- RBC (Red Blood Cell) units.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects age > 8 years old

  • Diagnosis of SCD, all genotypes

  • Require chronic red cell transfusion therapy

  • History of anti-D

  • RH genotype predicts D+ expression

Exclusion

Exclusion Criteria:

  • Rare RH genotype that would preclude sufficient RBC units

  • Antigen negative requirements due to alloimmunization that would preclude sufficientRBC units

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: D+ RH genotype matched red cell units for transfusion
Phase: 1
Study Start date:
July 08, 2020
Estimated Completion Date:
October 04, 2024

Study Description

Red blood cell transfusion remains a critical therapy for patients with sickle cell disease (SCD). A major problem is the high rate of alloimmunization (antibody formation against transfused red cells) that occurs in patients with SCD. Recent studies performed by Investigators and others demonstrate RH genetic variants in patients and donors is a major risk factor leading to Rh alloimmunization. Anti-D formation in D+ patients occurs frequently, and once identified, providing D- cells for all subsequent transfusions can be challenging. These anti-D antibodies in D+ patients suggest exposure to different or variant D protein on donor cells. Investigators will test whether transfusion of patients with anti-D with RHD genotyped matched red cells is feasible, safe and can decrease D- donor unit demand.

Connect with a study center

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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