A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Overview

About this study

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  • Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
  • Pediatric and adult patients of any age

Exclusion Criteria:

  • Patients who are receiving only licensed CBUs
  • Cord blood transplant recipients at international transplant centers
  • Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
  • Patients whose selected unlicensed CBU(s) will be more than minimally manipulated

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Michelle Skaar

(507) 284-4100

skaar.michelle@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

James Slack, M.D.

Open for enrollment

Contact information:

Catherine Margosian C.C.R.C.

(480) 342-1938

Margosian.Catherine@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Vivek Roy, M.D.

Open for enrollment

Contact information:

Virginia Lesperance M.S.N., R.N.

(904) 953-7222

Lesperance.Virginia@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20151028

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