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Umbilical Cord Blood Transplantation for Blood Disorders

This study is looking at how well umbilical cord blood stem cells from unrelated donors work for people with conditions like acute leukemia, immune deficiency, or aplastic anemia. Researchers want to see how quickly these transplanted cells start making new blood cells (engraftment) and if they fail to engraft. They are also tracking how often the original disease returns and how common and severe graft-versus-host disease (GvHD), a complication where the new cells attack your body, is. You could be eligible if you are between 2 months and 75 years old and have a condition that can be treated with a stem cell transplant. The study uses treatments like Total Body Irradiation (1200 cGy or 200 cGy), Cyclophosphamide, Mesna, and a Cord Blood Infusion. Success is measured by how quickly your blood cell counts recover, specifically within 42 days after the infusion.

Study design
This is an observational study with a planned enrollment of 30 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive a conditioning regimen and then an umbilical cord blood transplant. Your medical records would be reviewed for engraftment data.
Compensation
Not stated in the trial record.
Follow-up
Engraftment of blood cell counts is measured at 42 days after the stem cell infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03016806

Umbilical Cord Blood Transplantation From Unrelated Donors

Recruiting
Not specifiedAges 2–75Observational
University of Rochester
~30 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:Total Body Irradiation 1200 cGyTotal Body Irradiation 200 cGyCyclophosphamideMesnaCord Blood InfusionBusulfan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Engraftment of ANC and Platelets
Measured over 42 days following the infusion of stem cells for ANC [If engraftment of ANC does not occur within 42 days, a subsequent transplant will be performed if a donor is available.]

Conditions

Acute Leukemia
Immune Deficiency Disorder
Congenital Hematological Disorder
Metabolism Disorder
Aplastic Anemia
Myelodysplastic Syndromes
Chronic Leukemia
Lymphoma
Multiple Myeloma
Solid Tumor

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Omar Aljitawi, MD · PRINCIPAL_INVESTIGATOR · Professor - Department of Medicine, Hematology/Oncology (SMD)

Who to contact

Omar Aljitawi, MD
[email protected]
585-275-4099
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Eligibility criteria

Inclusion

Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy with hematopoietic stem cell transplantation. Diagnoses include, but are not limited to:
Congenital and Other Non-malignant Disorders:
Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome)
Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta)
Metabolic disorders (e.g. Hurler's Syndrome)
Severe aplastic anemia
High-Risk Leukemia:
Acute Myelogenous Leukemia
Refractory to standard induction therapy (more than 1 cycle required to achieve remission)
Recurrent (in CR ≥ 2)
Treatment-related AML or MDS
Evolved from myelodysplastic syndrome
Presence of FLT3 abnormalities
FAB M6 or M7
Adverse cytogenetics
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia including T lymphoblastic leukemia:
Refractory to standard induction therapy (time to CR \>4 weeks)
Recurrent (in CR ≥ 2)
WBC count \>30,000/mcL at diagnosis
Age \>30 at diagnosis
Adverse cytogenetics, such as t(9:22), t(1:19), t(4:11), and other MLL rearrangements.
Chronic Myelogenous Leukemia in accelerated phase or blast crisis
Biphenotypic or undifferentiated leukemia
Burkitt's leukemia or lymphoma
Lymphoma:
Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemo-sensitive, and ineligible for an autologous stem cell transplant or previously treated with autologous SCT
Marginal zone or follicular lymphoma that is progressive after at least two prior therapies
Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or ineligible for an autologous HSCT
Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease and disease status
Adequate organ function:
Cardiac - LVEF \>45%, or shortening fraction \>25%, Absence of congestive heart failure or conduction disturbances with high risk for sudden death
Pulmonary - DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted;
Renal - serum Cr \< 1.5 times the upper limit of normal for age or GFR ≥ 50 ml/min/1.73m2
Hepatic - total bilirubin level \< 2 times the upper limit of normal (except for patients with Gilbert's syndrome or hemolysis); if the primary disease process is causal, this criterion will be reconsidered. ALT, AST, and Alkaline phosphatase ≤ 5 times upper limit of normal.
Performance Status Karnofsky or Lansky score ≥ 70%.
Informed Consent must be obtained prior to initiating conditioning therapy.
Receipt of viable cord blood product(s), single or dual, must be confirmed with the stem cell processing laboratory prior to initiating conditioning therapy.

Exclusion

Availability of 10/10 or 9/10 HLA-matched related or unrelated donor within a reasonable timeframe dictated by the clinical urgency of the transplant
Autologous HSCT \< 6 months prior to proposed UCB transplant
Pregnant or breast feeding
Current uncontrolled infection
Evidence of HIV infection or positive HIV serology

What this trial measures

  • Engraftment of ANC and Platelets42 days following the infusion of stem cells for ANC [If engraftment of ANC does not occur within 42 days, a subsequent transplant will be performed if a donor is available.]

    The date of engraftment of ANC is the first of 3 consecutive days of ANC of 500 or higher based on daily CBC and Differential Counts. The date of engraftment of platelets is the first of three consecutive days of platelet counts of 20,000 or higher in the absence of platelet transfusions for a t least 7 days prior.