A multicenter safety study of unlicensed investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Investigation of Safety in Cord Blood Unit Administration

Recruiting
100 years or below
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

Detailed description of study

The purpose of this study is to evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Blood Transfusion
  • Age: 100 years or below
  • Gender: All

Inclusion Criteria
Patients with FDA-specified indications: Hematological malignancies, Certain lysosomal storage and peroxisomal enzyme deficiency disorders (Hurler syndrome (MPS I), Krabbe Disease (Globoid Leukodystrophy),and X-linked Adrenoleukodystrophy), Primary immunodeficiency diseases, Bone marrow failure, and Beta-thalassemia
Pediatric and adult patients of any age
Exclusion Criteria
Patients who are receiving only licensed CBUs
Cord blood transplant recipients at international transplant centers

Updated on 19 Feb 2024. Study ID: 1207009172

This study investigates the safety of administering investigational cord blood units. Cord blood is the blood that remains in the umbilical cord and placenta after birth, and it contains special cells called stem cells that can be used in medical treatments. The study aims to carefully document any problems related to the infusion of these units.

Participants in the study will receive investigational cord blood units, and the study will monitor for any infusion-related issues. The procedures will involve close observation and documentation of any side effects or complications that occur during the infusion process.

  • Who can participate: Both children and adults can join this study. They must have certain conditions like blood cancers or specific genetic disorders such as Hurler syndrome, Krabbe Disease, X-linked Adrenoleukodystrophy, primary immunodeficiency diseases, bone marrow failure, and beta-thalassemia. Patients receiving only licensed cord blood units or those at international transplant centers are excluded.
  • Study details: Participants will receive investigational cord blood units and will be monitored for any infusion-related problems. The study involves documenting side effects or complications that occur during the infusion process.

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