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
1 other identifier
interventional
10
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2004
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 6, 2004
CompletedFirst Posted
Study publicly available on registry
August 10, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedApril 12, 2007
April 1, 2007
August 6, 2004
April 11, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViaCelllead
Study Sites (4)
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kurt Gunter, MD
ViaCell
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 6, 2004
First Posted
August 10, 2004
Study Start
March 1, 2004
Study Completion
October 1, 2006
Last Updated
April 12, 2007
Record last verified: 2007-04