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

Tracking Information

First Received Date ^ICMJE

August 6, 2004

Last Updated Date

April 11, 2007

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00089596 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Non-Hodgkin Lymphoma
Chronic Myelogenous Leukemia

Intervention ^ICMJE

Procedure: Expansion of umbilical cord stem cells

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00089596

Responsible Party

Study ID Numbers ^ICMJE

CB001

Study Sponsor ^ICMJE

ViaCell

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Kurt Gunter, MD

ViaCell

Information Provided By

ViaCell

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP