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Blood Product

Genotype-Matched Blood Transfusion for Sickle Cell Disease

Phase < 1

Recruiting

Led By Stella Chou, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of SCD, all genotypes

Subjects age > 8 years old

Must not have

Antigen negative requirements due to alloimmunization that would preclude sufficient RBC units

Rare RH genotype that would preclude sufficient RBC units

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe to give patients with sickle cell disease who have the D+ blood type and have formed antibodies against D blood cells, D+ blood cells instead of the D- blood cells they currently receive during transfusions.

Who is the study for?

This trial is for people over 8 years old with sickle cell disease who need regular blood transfusions and have developed anti-D antibodies. They must have an RH genotype that suggests D+ expression. Those with rare RH genotypes or other immune responses preventing enough safe RBC units are excluded.

What is being tested?

The study tests the safety of giving chronically transfused sickle cell patients, who are D+ and have anti-D antibodies, red blood cells matched to their RH genotype instead of the usual D- units they receive.

What are the potential side effects?

While specific side effects aren't listed, potential risks may include reactions to mismatched blood such as fever, chills, or more serious complications like hemolytic transfusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with sickle cell disease.

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I am older than 8 years.

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I need regular blood transfusions to manage my condition.

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My RH genotype indicates D+ expression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need specific blood types for transfusions due to immune reactions.

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My blood type is very rare, making it hard to find enough blood for transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility and safety of providing RH genotype matched D+ RBCs to patients with SCD who type D+ but have formed anti-D

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: D+ RH genotype matched Red Blood Cell TransfusionExperimental Treatment1 Intervention

Investigators will provide one red cell unit of D+ RH genotype matched RBCs at the first transfusion study visit. The remainder of units will be provided per clinical standard of care, i.e. D-, CEK-matched, and negative for all other antigens the patient is alloimmunized against. If laboratory monitoring shows no reappearance of anti-D and no signs of increased red cell hemolysis, the patient will receive one unit of D+ RH genotype matched RBCs at the 2nd transfusion study visit, and if tolerated, D+ red cell exposures will increase by one unit per study visit until all units required are D+.

0 / 6Eligibility criteria met