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Cord Blood Units

Unlicensed Cord Blood Transplant for Blood/Immune System Disorders

Phase 2
Recruiting
Led By Patricia Shi, MD
Research Sponsored by New York Blood Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 48 hours of infusion
Awards & highlights

Study Summary

This trial will study the safety of using cord blood stem cells in patients with conditions that affect the blood or immune system.

Who is the study for?
This trial is open to people of any age and gender with disorders affecting the blood-making system, whether inherited, acquired or due to intensive treatment. Participants must receive at least one unlicensed cord blood unit (CBU) made by NCBP. It's not for those treated outside the US, receiving manipulated CBUs post-thaw, or exclusively licensed/unlicensed CBUs from other banks.Check my eligibility
What is being tested?
The study is testing the safety of infusing unlicensed investigational cord blood units (CBUs) manufactured by NCBP. The focus is on documenting all problems related to the infusion process to assess potential risks.See study design
What are the potential side effects?
While specific side effects are not listed, this study will monitor for any adverse reactions during the infusion of cord blood units which can include allergic reactions, fever, chills or other infusion-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a blood disorder that is inherited, acquired, or caused by treatment.
Select...
My cord blood transplant uses a product made by the NCBP.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 48 hours of infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 48 hours of infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of infusion-related reactions
Secondary outcome measures
engraftment

Trial Design

1Treatment groups
Experimental Treatment
Group I: unlicensed CBUExperimental Treatment1 Intervention
The Principal Investigators will be the transplant physicians at participating US transplant centers

Find a Location

Who is running the clinical trial?

New York Blood CenterLead Sponsor
23 Previous Clinical Trials
16,695 Total Patients Enrolled
Patricia Shi, MDPrincipal InvestigatorNY Blood Center
Alexandra Jimenez, MDPrincipal InvestigatorNY Blood Center

Media Library

Unlicensed CBU (Cord Blood Units) Clinical Trial Eligibility Overview. Trial Name: NCT01656603 — Phase 2
Infusion Reaction Research Study Groups: unlicensed CBU
Infusion Reaction Clinical Trial 2023: Unlicensed CBU Highlights & Side Effects. Trial Name: NCT01656603 — Phase 2
Unlicensed CBU (Cord Blood Units) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01656603 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can join this research program?

"Correct. Data found on clinicaltrials.gov indicates that this research project is actively recruiting participants, which commenced being posted on February 1st 2012 and was recently modified on April 19th 2022. A total of 9999 patients are being sought from 67 distinct medical facilities."

Answered by AI

Is this research endeavor currently accessible to participants?

"Current information posted to clinicaltrials.gov shows that this research project is recruiting participants. Its first post was on February 1st 2012 and the details were most recently updated April 19th 2022."

Answered by AI

What risks could potentially accompany the unauthorized use of CBU?

"Our team at Power has assigned unlicensed CBU a score of 2, as the drug is currently being tested in Phase 2 trials and thus there are some safety data but no efficacy evidence."

Answered by AI

Are there many venues conducting this research endeavor in North America?

"Participating in this medical trial is possible for those near many different locations, such as the Florida Hospital, Florida Center for Cellular Therapy based in Orlando fl, St. Louis University Hospital located in Saint Louis MO, and Northwestern Memorial Hospital in Chicago il."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1144 spots leftby Dec 2025