A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies

ClinicalTrials.gov ID: NCT00343798

Public ClinicalTrials.gov record NCT00343798. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Pilot Study to Evaluate the Co-infusion of Ex Vivo Expanded Umbilical Cord Blood Progenitors With an Unmanipulated Cord Blood Graft in Patients Undergoing Umbilical Cord Blood Transplantation for Hematologic Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase I multicenter feasibility trial is studying the safety and potential efficacy of infusing ex vivo expanded cord blood progenitors with one unmanipulated umbilical cord blood unit for transplantation following conditioning with fludarabine, cyclophosphamide and total body irradiation (TBI), and immunosuppression with cyclosporine and mycophenolate mofetil (MMF) for patients with hematologic malignancies. Chemotherapy, such as fludarabine and cyclophosphamide, and TBI given before an umbilical cord blood transplant stops the growth of leukemia cells and works to prevent the patient's immune system from rejecting the donor's stem cells. The healthy stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red blood cells, white blood cells, and platelets. It may take several weeks for these new blood cells to grow. During that period of time, patients are at increased risk for bleeding and infection. Faster recovery of white blood cells may decrease the number and severity of infections. Studies have shown that counts are more likely to recover more quickly if increased numbers of cord blood cells are given with the transplant. We have developed a way of growing or "expanding" the number of cord blood cells in the lab so that there are more cells available for transplant. We are doing this study to find out whether or not giving these expanded cells along with one unexpanded cord blood unit is safe and if use of expanded cells can decrease the time it takes for white blood cells to recover after transplant. We will study the time it takes for blood counts to recover, which of the two cord blood units makes up the patient's new blood system, and how quickly immune system cells return

Study identification

NCT ID: NCT00343798
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Fred Hutchinson Cancer Center; Other
Enrollment: 23 participants

Conditions and interventions

Conditions

Interventions

cyclophosphamide Drug
fludarabine phosphate Drug
cyclosporine Drug
mycophenolate mofetil Drug
ex-vivo umbilical cord blood expansion Other
double-unit umbilical cord blood transplantation Procedure
biopsy Procedure
immunologic technique Other
diagnostic laboratory biomarker analysis Other

Drug · Other · Procedure

Eligibility (public fields only)

Age range: 6 Months to 45 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 31, 2006
Primary completion: Jun 30, 2013
Completion: Not listed
Last update posted: Feb 10, 2015

Started 2006

United States locations

U.S. sites: 4
U.S. states: 3
U.S. cities: 4

Facility	City	State	ZIP	Site status
City of Hope Medical Center	Duarte	California	91010	—
University of Colorado Cancer Center - Anschutz Cancer Pavilion	Aurora	Colorado	80045	—
University of Colorado	Denver	Colorado	80217-3364	—
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	98109	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00343798, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 10, 2015 · Synced Sep 15, 2026

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