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

Purpose

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	Intervention	Phase
Acute Lymphocytic Leukemia Acute Myeloid Leukemia Myelodysplastic Syndrome Non-Hodgkin Lymphoma Chronic Myelogenous Leukemia	Procedure: Expansion of umbilical cord stem cells	Phase I Phase II

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Further study details as provided by ViaCell:

Estimated Enrollment:	10
Study Start Date:	March 2004
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	12 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089596

Locations


United States, Illinois
	Loyola University Medical Center
	Maywood, Illinois, United States, 60153

United States, Indiana
	Indiana University Cancer Center
	Indianapolis, Indiana, United States, 46202

United States, New Jersey
	Hackensack University Medical Center
	Hackensack, New Jersey, United States, 07601

United States, New York
	Roswell Park Cancer Institute
	Buffalo, New York, United States, 14263

Sponsors and Collaborators

ViaCell

Investigators


Study Director:	Kurt Gunter, MD	ViaCell

More Information

Study ID Numbers:	CB001
First Received:	August 6, 2004
Last Updated:	April 11, 2007
ClinicalTrials.gov Identifier:	NCT00089596
Health Authority:	United States: Food and Drug Administration

Keywords provided by ViaCell:

umbilical cord blood

transplant

ALL

AML

MDS

NHL

CML

Study placed in the following topic categories:

Myelodysplastic syndromes

Leukemia, Lymphoid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders

Chronic myelogenous leukemia

Precancerous Conditions

Hematologic Diseases

Myelodysplasia

Myelodysplastic Syndromes

Acute myelogenous leukemia

Lymphoma, small cleaved-cell, diffuse

Myeloproliferative Disorders

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia

Lymphatic Diseases

Preleukemia

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Bone Marrow Diseases

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Acute myelocytic leukemia

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Neoplasms by Histologic Type

Immune System Diseases

Syndrome

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	ViaCell
Information provided by:	ViaCell
ClinicalTrials.gov Identifier:	NCT00089596