Cord Blood Clinical Trials

Delaney Clinical Research Group

Fred Hutchinson Cancer Research Center's Cord Blood Program was launched in 2006. Since then, we have performed more than 300 transplants in patients with malignant and non-malignant diseases who range in age from less than 1 year to 71 years.

Cord Blood Treatment Research

The laboratory and clinical research components of the Cord Blood Program work together and in collaboration with our colleagues across Fred Hutch to improve outcomes for cord blood transplant recipients. This collaboration emphasizes understanding of how cord blood cells engraft (take hold in a patient), improving conditioning regimens, and developing standards of care for infection prevention. Our work has explored conventional as well as innovative approaches to achieving these goals. Outcomes for our patients reflect this effort, with survival rates equivalent to patients receiving unrelated donor bone marrow or peripheral blood hematopoietic cell transplants.

Below is a list of cord blood clinical trials. For information about open clinical trials, please contact Clinical Research Nurse Nancy Anderson via email.

For information about how to enroll in open clinical trials, please visit the Seattle Cancer Care Alliance.

Fred Hutchinson Cancer Research Center's Cord Blood Program was launched in 2006. Since then, we have performed more than 300 transplants in patients with malignant and non-malignant diseases who range in age from less than 1 year to 71 years.

Cord Blood Treatment Research

The laboratory and clinical research components of the Cord Blood Program work together and in collaboration with our colleagues across Fred Hutch to improve outcomes for cord blood transplant recipients. This collaboration emphasizes understanding of how cord blood cells engraft (take hold in a patient), improving conditioning regimens, and developing standards of care for infection prevention. Our work has explored conventional as well as innovative approaches to achieving these goals. Outcomes for our patients reflect this effort, with survival rates equivalent to patients receiving unrelated donor bone marrow or peripheral blood hematopoietic cell transplants.

Below is a list of cord blood clinical trials. For information about open clinical trials, please contact Clinical Research Nurse Nancy Anderson via email.

For information about how to enroll in open clinical trials, please visit the Seattle Cancer Care Alliance.


Cord Blood Program Clinical Trials

Open to enrollment

 

Completed Trials

  • 2044: 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
    This trial, initiated in 2006, was the first clinical trial to use Notch-mediated ex vivo expanded cord blood stem and progenitor cells in the setting of a myeloablative double cord blood transplant. As a first-in-human study, the primary objective of this trial was safety of infusing our expanded cord blood progenitor cells. All patients on this trial underwent a cord blood transplant with two cord blood units (“double cord blood transplant), each selected on the basis of HLA-matching and cell dose. Approximately two weeks prior to transplant, one unit was thawed and the CD34+ stem cells were isolated and placed into culture. On the day of transplant, the expanded cells were then harvested and infused into the patient 4 hours after infusion of the second unmanipulated cord blood unit. There were no adverse events attributed to the expanded cell product. In addition to safety, this study also examined the time it took for recovery of blood counts (engraftment) to occur and which unit (donor) of cord blood was responsible for the blood count recovery.

    For results, please see Delaney C, Heimfeld S, Brashem-Stein C, Voorhies H, Manger R and Bernstein ID. Notch-mediated expansion of human cord blood progenitor cells capable of rapid myeloid reconstitution. Nature Medicine, 2010 Feb;16(2):232-6 ,with updated data in ASH abstract: C Delaney, F Milano, I Nicoud, S Heimfeld, C Karanes, J Gutman, J Wagner, F Appelbaum,I Bernstein. Dose Dependent Enhancement of Neutrophil Recovery by Infusion of Notch Ligand Ex Vivo Expanded Cord Blood Progenitors: Results of a Multi-Center Phase I Trial. ASH Annual Meeting, December 2013.
  • 2128: Multi-center, Open label, Randomized Trial Comparing Single Versus Double Umbilical Cord Blood Transplantation in Pediatric Patients with High Risk Leukemia and Myelodysplasia (BMT-CTN 0501)
    Our site was one of multiple clinical sites across the country participating in this national trial conducted by the BMT CTN to determine whether giving two units of cord blood to a patient is better or worse than giving one cord blood unit.

    For results, please see Wagner JE, Eapen M, Carter S, Wang Y, Schultz KR, Wall DA, Bunin N, Delaney C, Haut P, Margolis D, Peres E, Verneris MR, Walters M, Horowitz MM, Kurtzberg J; Blood and Marrow Transplant Clinical Trials Network. One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J Med. 2014 Oct 30;371(18):1685-94.
  • 2335: Clofarabine in Combination with Cytarabine (Ara-C) and G-CSF Priming Followed by Infusion of Ex Vivo Expanded Cord Blood Progenitors for Patients with AML
    The primary purpose of this study was to determine whether giving non-HLA matched cryopreserved expanded cord blood progenitor cells after intensive chemotherapy is safe in adult patients with AML. Secondary objectives were to assess the ability of the product to provide temporary myeloid engraftment, the kinetics/persistence of potential engraftment, the kinetics of autologous recovery when compared to historical cohorts, and the development of alloimmunization.

    For results, please see Delaney C, Milano F, Cicconi L, Othus M, Becker PS, Sandhu V, Nicoud I, Dahlberg A, Bernstein IDB, Appelbaum FR, Estey EH. Infusion of a non-HLA-matched ex-vivo expanded cord blood progenitor cell product after intensive acute myeloid leukaemia chemotherapy: a phase 1 trialLancet Haematol. 2016 Jul;3(7):e330-9. Epub 2016 Jun 7.
  • 2584: Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Induction Chemotherapy (FLAG) in Patients with Relapsed/Refractory AML 
    For patients 2 to 30 years old. The purpose of this study is to determine whether giving cryopreserved expanded cord blood cells** after chemotherapy is safe in children and young adult patients. This study is closed to accrual with follow-up ongoing.