NCT01351545

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Study Contact:

Shannon Clark, MS - Role: CONTACT - Phone: - Email: 10-CBA@ndmp.org

Study Phase:

Recruitment Status:

RECRUITING

NCT ID:

NCT01351545

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications

Summary

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Eligibility

Inclusion Criteria:

* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age

Exclusion Criteria:

* Patients who are receiving only licensed CBUs
* Cord blood transplant recipients at international transplant centers
* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated

Disease(s) and\or Condition(s)

Hematologic Malignancies

Inherited Disorders of Metabolism

Inherited Abnormalities of Platelets

Histiocytic Disorders

Acute Myelogenous Leukemia (AML or ANLL)

Acute Lymphoblastic Leukemia (ALL)

Other Acute Leukemia

Chronic Myelogenous Leukemia (CML)

Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases

Other Leukemia

Hodgkin Lymphoma

Non-hodgkin Lymphoma

Multiple Myeloma/ Plasma Cell Disorder (PCD)

Inherited Abnormalities of Erythrocyte Differentiation or Function

Disorders of the Immune System

Autoimmune Diseases

Severe Aplastic Anemia

Primary Purpose

Intervention/Treatment

- Type: DRUG
- Name: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
- Description: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications
- Arm Group Labels: Unlicensed CBU

Sponsor

Center for International Blood and Marrow Transplant Research