What side effects are associated with this type of intervention?

Common treatments for infusion reactions, particularly those involving stem cells such as cord blood infusions, can have several side effects. These include infusion-related problems like fever, chills, and allergic reactions. More severe side effects can include graft-versus-host disease (GVHD), infections due to immunosuppression, and organ toxicity. In some cases, there may be complications related to the infusion procedure itself, such as infusion-related cytokine release syndrome, which can cause symptoms ranging from mild flu-like symptoms to severe inflammatory responses.

What prior FDA approvals exist?

FDA-approved treatments for infusion reactions, particularly in the context of stem cell or cord blood infusions, often include premedications such as antihistamines (e.g., diphenhydramine), corticosteroids (e.g., methylprednisolone), and antipyretics (e.g., acetaminophen) to prevent or mitigate reactions. Additionally, intravenous immune globulin (IVIG) is sometimes used to manage severe immune responses. These treatments aim to reduce the risk of anaphylaxis, fever, chills, and other infusion-related complications.

What other types of research exist?

Promising alternatives to cord blood infusion for patients with infusion reactions include mesenchymal stem cells (MSCs), which have shown beneficial effects in multiple sclerosis and other conditions due to their immunomodulatory properties. Autologous hematopoietic cell transplantation (HCT) is another option, particularly for conditions like chronic lymphocytic leukemia (CLL) and multiple sclerosis, offering reduced relapse rates and improved overall survival. Additionally, novel therapies such as luspatercept for myelodysplastic syndromes and imetelstat for transfusion-dependent anemia are emerging as effective treatments with potentially fewer infusion-related complications.

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Cord Blood Units

Unlicensed Cord Blood Transplant for Blood/Immune System Disorders

Phase 2

Recruiting

Led By Patricia Shi, MD

Research Sponsored by New York Blood Center

Eligibility Criteria Checklist

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

Must have

Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment

Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)

Must not have

Patients who are receiving licensed cord blood products

Patients who are receiving cord blood products that will be 'manipulated' post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 48 hours of infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of giving patients special blood from umbilical cords. The study focuses on patients who receive these infusions to see if there are any serious side effects. The cord blood has special cells that can help make new blood cells in the body. Umbilical cord blood has been used in the treatment of various diseases for many years, including leukemia, lymphoma, and congenital immunodeficiency.

Who is the study for?

This trial is open to people of any age and gender with disorders affecting the blood-making system, whether inherited, acquired or due to intensive treatment. Participants must receive at least one unlicensed cord blood unit (CBU) made by NCBP. It's not for those treated outside the US, receiving manipulated CBUs post-thaw, or exclusively licensed/unlicensed CBUs from other banks.

What is being tested?

The study is testing the safety of infusing unlicensed investigational cord blood units (CBUs) manufactured by NCBP. The focus is on documenting all problems related to the infusion process to assess potential risks.

What are the potential side effects?

While specific side effects are not listed, this study will monitor for any adverse reactions during the infusion of cord blood units which can include allergic reactions, fever, chills or other infusion-related complications.

Eligibility Criteria

Inclusion Criteria

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

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I have a blood disorder that is inherited, acquired, or caused by treatment.

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My cord blood transplant uses a product made by the NCBP.

Exclusion Criteria

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

Select...

I am currently receiving treatment with licensed cord blood products.

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I am receiving a cord blood treatment that involves special processing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 48 hours of infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 48 hours of infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 48 hours of infusion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of infusion-related reactions

Secondary study objectives

engraftment

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: unlicensed CBUExperimental Treatment1 Intervention

The Principal Investigators will be the transplant physicians at participating US transplant centers

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for infusion reactions, such as febrile nonhemolytic transfusion reactions (FNHTR), include the use of leukocyte-poor red blood cells (LP RBCs). LP RBCs reduce the number of leukocytes, which are often responsible for triggering immune responses that cause fever and chills during transfusions. For patients receiving treatments like anti-CD20 monoclonal antibodies (e.g., rituximab), premedication with antihistamines and corticosteroids is often used to mitigate severe infusion reactions by dampening the immune response. These treatments are crucial for infusion reaction patients as they help prevent potentially severe and uncomfortable reactions, ensuring the safety and efficacy of the transfusion or infusion therapy.

Febrile transfusion reaction: what blood component should be given next?Allogeneic cord blood transfusions prevent fetal haemoglobin depletion in preterm neonates. Results of the CB-TrIP study.Granulocyte transfusions in children and adults with hematological malignancies: benefits and controversies.