Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy

Withdrawn before enrolling · Phase 2

Conditions studied: Severe Hypoxic-ischemic Encephalopathy

In brief

The purpose of this study is to investigate the safety and effectiveness of autologous human placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates with severe hypoxic-ischemic encephalopathy.

Key facts

Study ID

NCT02434965

Run by

New York Medical College

People needed

0

Starts

2019-12-01

Expected to finish

2022-01-01

Last updated by the study team

2021-02-23

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age ≥ 36 weeks
• Birth weight ≥ 1800 grams
• Postnatal age after birth of less than 6 hours
• Autologous cord blood and HPDSCs available for infusion
• Plus one or more of the following criteria: Apgar ≤ 5 at 10 minutes of postnatal age, or Continued need for resuscitation ≥10 min after birth, or Acidosis-cord blood pH or arterial blood pH within 60 minutes of birth ≤ 7.0 pH, or Base deficit ≥ minus 16mEq in cord blood and within 60 min of birth.
• Plus Moderate to Severe Altered State of Consciousness, by one or more of the following: Hypotonia, or Abnormal reflexes, or Absent/weak suck.

You may not qualify if…

• Major life-threatening or surgical anomalies
• Polycythemia (hematocrit > 65%)
• Congenital infection based on antenatal diagnosis of TORCH infection
• Parental refusal for study
• Infant expected to live < 24h, medical care is considered futile and no additional therapy will be offered by the attending neonatologist

Where it is running

• New York Medical College — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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