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

NCT ID: NCT00089596

Last Updated: 2007-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-10-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Expansion of umbilical cord stem cells

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViaCell

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kurt Gunter, MD

Role: STUDY_DIRECTOR

ViaCell

Locations

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Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Indiana University Cancer Center

Indianapolis, Indiana, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CB001

Identifier Type: -

Identifier Source: org_study_id

NCT00301704

Identifier Type: -

Identifier Source: nct_alias