Back to resultsInfusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers
Primary Purpose
Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Expansion of umbilical cord stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphocytic Leukemia focused on measuring umbilical cord blood, transplant, ALL, AML, MDS, NHL, CML
Eligibility 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
Sites / Locations
- Loyola University Medical Center
- Indiana University Cancer Center
- Hackensack University Medical Center
- Roswell Park Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00089596
Brief Title
Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers
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 Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
ViaCell
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia
Keywords
umbilical cord blood, transplant, ALL, AML, MDS, NHL, CML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Expansion of umbilical cord stem cells
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Gunter, MD
Organizational Affiliation
ViaCell
Official's Role
Study Director
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers
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