Actively Recruiting

Age: 2Months - 75Years
All Genders
NCT03016806

Umbilical Cord Blood Transplantation From Unrelated Donors

Led by University of Rochester · Updated on 2025-10-10

30

Participants Needed

1

Research Sites

626 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Another purpose will be to document the rate of disease-free survival and the rate of relapse (a return of your disease or syndrome) as well as the incidence and severity of graft versus host disease (GvHD) following cord blood stem cell transplantation. GvHD is a complication of stem cell transplants in which white blood cells from the transplanted tissue (graft) attack the transplant recipient's body (host).

CONDITIONS

Official Title

Umbilical Cord Blood Transplantation From Unrelated Donors

Who Can Participate

Age: 2Months - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have a disease or syndrome treatable with hematopoietic stem cell transplantation, including immune deficiency disorders, congenital hematopoietic defects, metabolic disorders, severe aplastic anemia, various types of leukemia, myelodysplastic syndromes, lymphoma, multiple myeloma, and certain solid tumors
  • Patients must have adequate organ function: cardiac (LVEF >45% or shortening fraction >25%), pulmonary (DLCO, FEV1, and FVC ≥ 50% predicted), renal (serum creatinine <1.5 times upper limit of normal or GFR ≥ 50 ml/min/1.73m2), and hepatic (bilirubin <2 times upper limit of normal, ALT, AST, and alkaline phosphatase ≤ 5 times upper limit of normal)
  • Performance status Karnofsky or Lansky score ≥ 70%
  • Informed consent obtained before starting conditioning therapy
  • Confirmation of receipt of viable single or dual cord blood products from stem cell processing laboratory before conditioning
Not Eligible

You will not qualify if you...

  • Availability of a fully or nearly fully HLA-matched related or unrelated donor within a timeframe suitable for the needed transplant
  • Autologous stem cell transplant within 6 months before the planned umbilical cord blood transplant
  • Pregnancy or breastfeeding
  • Current uncontrolled infection
  • Evidence of HIV infection or positive HIV test

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Wilmot Cancer Institute

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

O

Omar Aljitawi, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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