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.