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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00089596

Enrollment

Registered

2004-08-10

Start date

2004-03-31

Completion date

2006-10-31

Last updated

2007-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

umbilical cord blood, transplant, ALL, AML, MDS, NHL, CML

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.

Interventions

PROCEDUREExpansion of umbilical cord stem cells

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 60 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026