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

Severe Hypoxic-ischemic Encephalopathy Clinical Trial

— HPDSC+HIE  

Official title:

A Safety and Feasibility Study of Autologous Cord Blood (CB) and Human Placental Derived Stem Cells (HPDSC) in Neonates With Severe Hypoxic-Ischemic Encephalopathy (HIE)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02434965
• Other study ID #: NYMC-554
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2019
• Est. completion date: January 2022

Study information

• Verified date: September 2019
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The primary aim of this study is to determine the safety, tolerability and feasibility of intravenous administration of autologous cord blood (CB) and autologous human placental derived stem cells (HPDSC) in neonates with severe hypoxic-ischemic encephalopathy (HIE). It is hypothesized that the administration of autologous CB and autologous HPDSC will be safe and well tolerated in neonates with severe HIE.

Additionally, postnatal neuro-developmental outcomes in neonates with HIE after autologous CB and HPDSC therapy will be measured; HIE injury to the neonate/infant brain post autologous CB and HPDSC therapy by imaging will be characterized; the pluripotent stem cell properties of CB and HPDSC will be characterized; serum levels of selected circulating cytokine and neurotrophic factors in neonates with HIE before and after autologous CB and HPDSC therapy will be compared and immune cell phenotype and function in neonates with HIE before and after autologous CB and HPDSC therapy will be compared.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia
• Severe Hypoxic-ischemic Encephalopathy

Intervention

Drug:
• HPDSC
Autologous HPDSC collected after birth will be infused in aliquots. one-half of the HPDSC infused on Day 2; one-half of the collected HPDSC will be infused on Day 8.
• Cord blood
Autologous Cord Blood collected after birth will be infused in aliquots. One-third of the collected cord blood will be infused within the first 24 hours after birth (Day 0); one-third of the collected cord blood will be infused on day 3; and one-third of the collected cord blood unit will be infused on Day 7.

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Medical College	Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with infusion reaction as a measure of safety and tolerability	Any infusion reaction to autologous human placental-derived stem cells (HPDSC) administered in conjunction autologous cord blood in neonates with severe hypoxic-ischemic encephalopathy will be assessed for safety and tolerability	within the first 30 days
Secondary	Improvement in neurological condition	Improvement in neurological condition as shown on head MRI, DTI and neurological development by Sarnat testing.	2 years post HPDSC infusion