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

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study provides access to frozen cord blood units that are not licensed. It is for children and adults with blood cancers or other conditions that affect the body's blood-making system.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a condition that affects the body's blood-making system. It may be inherited, develop later in life, or result from treatment that destroys blood-making cells.
  • Sign a consent form before joining. Children must also sign an agreement if required.
  • Children and adults of any age may join.

Who can't join

  • Receive only licensed cord blood units.
  • Receive a cord blood transplant at an international transplant center.
  • Are in another study that provides access to the unlicensed cord blood units.
  • The chosen unlicensed cord blood units will be processed in ways that change them more than slightly.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (142)

AL

AR

AZ

CA

CO

CT

DC

DE

FL

GA

HI

IA

IL

IN

KS

KY

LA

MA

MD

MI

MN

MO

MS

NC

NE

  • University of Nebraska Medical Center · Omaha, NE 68198-2168Phyllis Warkenton, MD · Study contact · pwarkent@unmc.eduPhyllis Warkenton, MD · Principal investigatorMore trials in Omaha

NJ

NY

OH

OK

OR

  • Oregon Health & Science University/Doernbecher Children's Hospital · Portland, OR 97239Eneida Nemecek, MD · Study contact · nemeceke@ohsu.eduEneida Nemecek, MD · Principal investigatorMore trials in Portland

PA

RI

SC

SD

TN

TX

UT

VA

WA

WI

WV