Completed

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

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What is being tested

Data Collection

Who is being recruted

Bone Marrow Diseases+20

+ Chronic Disease

+ Hematologic Diseases

From 12 to 60 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorViaCell
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation
NCT00089596NCT00301704
Principal SponsorViaCell
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersMyelodysplastic SyndromesMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, AcuteDisease AttributesPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Criteria

8 inclusion criteria required to participate
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
Show More Criteria
11 exclusion criteria prevent from participating
Females who are pregnant
Poor ability to perform daily activities
Weight under 40 kilograms (88 pounds)
AML caused by chemoradiation
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Loyola University Medical Center

Maywood, United StatesOpen Loyola University Medical Center in Google Maps
Suspended

Indiana University Cancer Center

Indianapolis, United States
Suspended

Hackensack University Medical Center

Hackensack, United States
Suspended

Roswell Park Cancer Institute

Buffalo, United States
Completed4 Study Centers