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

Recruiting at 126 trial locations

Overseen By Lisa Erickson, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Center for International Blood and Marrow Transplant Research

Disqualifiers: Licensed CBUs, International centers, Other IND, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

99999 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Miller, MD, PhD

Principal Investigator

NMDP/CIBMTR

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants receive unlicensed cryopreserved cord blood units (CBUs) for transplantation

Immediate

Engraftment Monitoring

Monitoring of neutrophil recovery and other engraftment parameters post-transplant

8 weeks

Follow-up

Participants are monitored for safety, infection transmission, infusion reactions, and GVHD

1 year

Treatment Details

Interventions

• Unlicensed Cryopreserved Cord Blood Units

Participant Groups

Group I: Unlicensed CBU Experimental Treatment 1 Intervention

The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.

Who Is Running the Clinical Trial?

Center for International Blood and Marrow Transplant Research

Lead Sponsor

Trials

40

Recruited

200,190,000+

National Marrow Donor Program

Collaborator

Trials

63

Recruited

202,000+