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

Sponsor

ViaCell (Industry)

Overall Status

Completed

CT.gov ID

NCT00089596

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphocytic Leukemia Acute Myeloid Leukemia Myelodysplastic Syndrome Non-Hodgkin Lymphoma Chronic Myelogenous Leukemia	Procedure: Expansion of umbilical cord stem cells	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2004

Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Medical Center	Maywood	Illinois	United States	60153
2	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202
3	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
4	Roswell Park Cancer Institute	Buffalo	New York	United States	14263