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Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy (HPDSC+HIE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by New York Medical College
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
New York Medical College
ClinicalTrials.gov Identifier:
NCT02434965
First received: April 27, 2015
Last updated: October 4, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Severe Hypoxic-ischemic Encephalopathy
Drug: HPDSC
Drug: Cord blood
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Number of subjects with infusion reaction as a measure of safety and tolerability [ Time Frame: within the first 30 days ]
    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


Secondary Outcome Measures:
  • Improvement in neurological condition [ Time Frame: 2 years post HPDSC infusion ]
    Improvement in neurological condition as shown on head MRI, DTI and neurological development by Sarnat testing.


Estimated Enrollment: 20
Study Start Date: January 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Cord Blood and HPDSC
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
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.
Drug: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02434965

Contacts
Contact: Mitchell S Cairo, MD 914-594-2150 mitchell_cairo@nymc.edu
Contact: Erin Morris, RN 714-964-5359 erin_morris@nymc.edu

Locations
United States, New York
New York Medical College Not yet recruiting
Vallhala, New York, United States, 10595
Contact: Mitchell S Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Principal Investigator: Mitchell S. Cairo, MD         
Sponsors and Collaborators
New York Medical College
Celgene
Investigators
Principal Investigator: Mitchell S Cairo, MD New York Medical College
  More Information

Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT02434965     History of Changes
Other Study ID Numbers: NYMC-554
Study First Received: April 27, 2015
Last Updated: October 4, 2016

Keywords provided by New York Medical College:
Neonates
hypoxic-ischemic encephalopathy
human placental-derived stem cells
autologous

Additional relevant MeSH terms:
Ischemia
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain

ClinicalTrials.gov processed this record on March 22, 2017