CMV CTLs in Neonates with CMV Infection

Inclusion Criteria:

• Age: ≤ 21 days of life

• Birth Weight: ≥ 2500 gms

• Gestational age: ≥ 34 weeks of age

• Diagnosis of CMV viremia, viruria, and/or infection:Either one or more:

Elevated CMV by RT-PCR in urine, saliva, CSF, or plasma; and/or Positive urine culture for CMV

• Moderate or Severe CMV Disease

Any one or more of the following attributable to congenital CMV infection:

• Thrombocytopenia (≤ 50,000 mm3)

• Multiple petechiae

• Hepatomegaly

• Splenomegaly

• Intrauterine growth retardation

• Increased transaminases

• Increased bilirubin

• Microcephaly

• Ventriculomegaly

• Intracerebral calcifications

• Periventricular echogenicity

• Cortical or cerebral malformation

• Chorioretinitis

• Severe neonatal hearing loss

• CMV DNA by PCR in CNS

• Increased WBC for age in CNS

• Minimal Organ Criteria Hematological: ANC ≥ 750/mm3, HgB ≥ 8gm/dl, Platelets ≥ 20,000/kmm3 Renal: Serum creatinine ≤ 1.0 mg/dl Hepatic: ALT/SGOT ≤3x upper normal limits

• Donor Availability: Maternal donor available with a T-cell response CMV MACS® PepTivators. the donor is considered suitable if the percentage of IFN-gamma+ T cells is > 0.01% after stimulation with PepTivators.

Exclusion Criteria -

• Patient receiving steroids (> 0.5 mg/kg prednisone equivalent) on the same day of CMV CTL infusion. Antenatal steroids for lung maturation will have been cleared prior to CMV diagnosis.

• Concomitant enrollment in another experimental clinical trial investigating the treatment of neonatal CMV viremia and/or infection.

• Any medical condition that could compromise participation in the study according to the investigator's assessment.

• Known history of HIV infection in the mother.

• Patient's legally authorized representative unwilling or unable to comply with the protocol or unable to give informed consent.