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. 2020 Aug 19;2020(8):CD013202. doi: 10.1002/14651858.CD013202.pub2

NCT01506258.

Study name Autologous stem cells in newborns with oxygen deprivation
Methods a open‐labelled non‐randomised interventional study with parallel assignment
Participants Infants between 37 to 42 weeks of GA.
Inclusion criteria
  • Apgar < 5 at 5 minutes

  • Mixed or metabolic acidosis with a pH < 7.0 from umbilical cord blood sample

  • Neurological manifestations compatible with hypoxic‐ischemic encephalopathy

  • Any degree of organic/systemic affectation (cardiovascular, gastrointestinal, haematologic and/or respiratory)

Interventions
  • IV infusion of autologous cord and placental cord blood

  • Comparison group: control group of patients that meet the inclusion criteria but that do not wish to have the intervention.

Outcomes Primary outcomes
Effects of stem cell infusion at 1 week and 1 year after discharge: clinical assessment, including the Amiel‐Tison Neurological Assessment
Secondary outcomes: not nominated.
Starting date January 2012
Contact information Principal Investigator: Consuelo Mancias‐Guerra, MD; Hospital Universitario Dr. Jose E. Gonzalez
Study Director: Alma R Marroquin‐Escamilla, MD; Hospital Universitario Dr. Jose E. Gonzalez
Study Chair: David Gómez‐Almaguer, MD; Hospital Universitario Dr. Jose E. Gonzalez
Notes Study sponsor: Hospital Universitario Dr. Jose E. Gonzalez