Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNew York Blood Center

About this trial

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Patients: Patients of any age and either gender

Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)

Disqualifiers

Patients who are receiving licensed cord blood products (only)

Patients who are receiving unlicensed cord blood products from other banks (only)

Patients who are transplanted at non-US transplant centers

Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

Trial design

Design model

Single group

Treatments tested in this trial

  • unlicensed CBU

    Biological/Vaccine

    infusion of unlicensed cord blood units

Treatment groups

9,999 Participants
are divided into 1 treatment group
Group A: unlicensed CBUExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of infusion-related reactions

The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. The study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP cord blood units.

Time frame
within 48 hours of infusion

Secondary outcomes

1

engraftment

This outcome will evaluate engraftment of unlicensed cord blood units

Time frame
six months after transplant

Other outcomes

Sponsors and contacts

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