Human Placental-Derived Stem Cell Transplantation

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to investigate the safety of human placental-derived stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in patients with various malignant or nonmalignant disorders who require a stem cell transplant. Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and immunotherapy followed by a stem cell transplantation with UCB and HPDSC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College

Criteria

Inclusion Criteria:

• < 55 years of age

• Life expectancy greater than 3 months

• Lansky performance status ≥ 50% (children) or Karnofsky performance status ≥ 70% (adults) or ECOG performance status 0-2 (adults)

• DLCO > 50 percent predicted

• Left ventricular ejection fraction > 40% estimated

• Creatinine clearance or estimated GFR . 60 mL/min/1.73m2

• Serum bilirubin < 1.5x upper limit of normal

• Transaminases < 3x upper limit of normal

• Absence of uncontrolled infection

• HIV negative

Exclusion Criteria:

• Fanconi Anemia

• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

• Uncontrolled infection

• Pregnant or breast-feeding females

• Received other investigational agents within 30 days prior to the start of the conditioning regimen