NCT01656603

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

Study Contact:

Dorothy Sung - Role: CONTACT - Phone: 718-706-5202 - Email: dsung@nybc.org
Emeline Masson Frenet - Role: CONTACT - Phone: 718-752-4710 - Email: ncbp@nybc.org

Study Phase:

PHASE2

Recruitment Status:

RECRUITING

NCT ID:

NCT01656603

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients

Summary

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

Eligibility

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.)

Disease(s) and\or Condition(s)

Infusion Reactions

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: unlicensed CBU
- Description: infusion of unlicensed cord blood units
- Arm Group Labels: unlicensed CBU

Sponsor

New York Blood Center