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

NCT02434965 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: NYMC-554
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Hypoxic-ischemic Encephalopathy

Keywords

Neonates; hypoxic-ischemic encephalopathy; human placental-derived stem cells; autologous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in neurological condition

  2 years post HPDSC infusion

Study Arms (1)

Autologous Cord Blood and HPDSC

EXPERIMENTAL

Autologous cord blood and placental blood will be collected after birth of child and administered in divided aliquots during the first week of life.

Drug: HPDSC; Drug: Cord blood

Interventions

HPDSC DRUG

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.

Autologous Cord Blood and HPDSC

Cord blood DRUG

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.

Autologous Cord Blood and HPDSC

Eligibility Criteria

• Age: 1 Minute - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• New York Medical College: lead
• Celgene: collaborator

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitchell S Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 6, 2015
• Study Start: December 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 23, 2021

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)