A Study of the Safety of Unlicensed, Investigational Cord Blood Units Manufactured by the National Cord Blood Program for use in Stem Cell Transplants to Unrelated People.

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 13-000063
    • Scottsdale/Phoenix, Arizona: 14-005495
    NCT ID: NCT01656603
    Sponsor Protocol Number: 6637-01

About this study

The purpose of this study is to evaluate the safety of using unlicensed cord blood units from the National Cord Blood Program in unrelated  patients needing stem cell transplants, by carefully documenting all infusion-related problems.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Have disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  • Any age and either gender
  • Using a cord blood product manufactured by the National Cord Blood Program (at least one, if the graft contains more than one unit)

Exclusion Criteria

  • Are only receiving licensed cord blood products
  • Are only receiving unlicensed cord blood products from other banks
  • Are being transplanted at non-US transplant centers
  • Are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Hogan, M.B., B.Ch.

Contact us for the latest status

Contact information:

Kristin Cornwell R.N.

(507)284-6814

Cornwell.kristin@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Veena Fauble, M.D.

Closed for enrollment

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CLS-20231997

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