Umbilical Cord Blood Transplantation From Unrelated Donors

Inclusion criteria

• 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
• 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 criteria

• 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