Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

Phase 2

Recruiting

• Conditions: Infusion Reactions

• Registration Number: NCT01656603
• Lead Sponsor: New York Blood Center

Brief Summary

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Detailed Description

The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (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 cord blood (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).

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9999

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of infusion-related reactions	within 48 hours of infusion	The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. 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 cord blood units.

Secondary Outcome Measures

Name	Time	Method
engraftment	six months after transplant	This outcome will evaluate engraftment of unlicensed cord blood units

Trial Locations

Locations (71)

Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

University of Arizona Medical Center; 🇺🇸 Tucson, Arizona, United States

City of Hope; 🇺🇸 Duarte, California, United States

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA Healthcare; 🇺🇸 Los Angeles, California, United States

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Stanford Health Care; 🇺🇸 Stanford, California, United States

Scroll for more (61 remaining)