Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers

Acute Myeloid Leukemia Clinical Trial

Official title:

A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089596
• Other study ID #: CB001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 6, 2004
• Last updated: April 11, 2007
• Start date: March 2004
• Est. completion date: October 2006

Study information

• Verified date: April 2007
• Source: ViaCell
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells that are needed to make the different types of cells in their blood, including their immune system cells. These cells must be replaced in order for the blood and immune systems to work properly. Some people receive bone marrow transplants or other types of stem cell transplants to get the cells they need. CB001 is being developed as an option for people who need bone marrow transplants or other types of transplants to replace those cells. It is also being developed for people who do not have the option of other types of transplants.

Other known NCT identifiers

• NCT00301704

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

• Do not have identical or 5/6 related matched bone marrow, peripheral blood or umbilical cord

• Stable disease and lack of unrelated donor

• Acute myeloid leukemia (AML) in 2nd or subsequent complete remission or first remission with high risk features

• ALL in 2nd or subsequent remission or first remission with high risk features

• Myelodysplastic syndrome (MDS)

• Non-Hodgkin Lymphoma (NHL)

• Chronic Myelogenous Leukemia (CML)

• Adequate function of heart, liver, kidneys and lungs

Exclusion Criteria:

• Females who are pregnant

• Poor ability to perform daily activities

• Weight under 40 kilograms (88 pounds)

• AML caused by chemoradiation

• Prior stem cell transplant

• Uncontrolled infection at time of transplant

• Active fungal infection

• HIV infection

• Primary myelofibrosis

• Receiving other research drugs

• Unable to provide informed consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Acute Myeloid Leukemia
• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma, Non-Hodgkin
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Non-Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Procedure:
• Expansion of umbilical cord stem cells

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
ViaCell

Country where clinical trial is conducted

United States,