Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation

Protocol: OSU-12097

Full Title

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

Purpose

This study will evaluate the safety of infusion of the investigational cord blood units by

carefully documenting all infusion-related problems.

Study Objective

The primary aim of this study is to examine the safety of administration of the unlicensed

investigational NCBP HPC-CORD BLOOD products in a multi-institution setting. Therefore, the

study will evaluate prospectively the incidence of serious adverse reactions as well as the

incidence of all infusion related reactions after administration of the unlicensed,

investigational NCBP CBU.

Definitions of Infusion-related adverse reactions:

Mild - Moderate: reactions during or after the infusion of the CB product that require some

medical intervention but do not affect the overall patient status or outcome.

Severe: serious, life-threatening or fatal infusion reactions, requiring major medical

intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure,

seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB

infusion. Adverse Reactions will also be classified by grade, according to the Common

Terminology Criteria for Adverse Events v4.0 (CTCAE).

Are you eligible?

Inclusion Criteria:

Inclusion Criteria:

1. Diagnosis: Patients with disorders affecting the hematopoietic system that are

inherited, acquired, or result from myeloablative treatment.

2. Patients: Patients of any age and either gender

3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more

than one units)

Exclusion Criteria:

1. Patients who are receiving licensed cord blood products (only)

2. Patients who are receiving unlicensed cord blood products from other banks (only)

3. Patients who are transplanted at non-US transplant centers

4. Patients who are receiving cord blood products that will be "manipulated" post-thaw

(e.g., ex vivo expansion, incubation in vitro, etc.)

Exclusion Criteria:

Inclusion Criteria:

1. Diagnosis: Patients with disorders affecting the hematopoietic system that are

inherited, acquired, or result from myeloablative treatment.

2. Patients: Patients of any age and either gender

3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more

than one units)

Exclusion Criteria:

1. Patients who are receiving licensed cord blood products (only)

2. Patients who are receiving unlicensed cord blood products from other banks (only)

3. Patients who are transplanted at non-US transplant centers

4. Patients who are receiving cord blood products that will be "manipulated" post-thaw

(e.g., ex vivo expansion, incubation in vitro, etc.)