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History of Changes for Study: NCT02434965
Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy (HPDSC+HIE)
Latest version (submitted February 19, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 30, 2015 None (earliest Version on record)
2 November 18, 2015 Study Status
3 October 4, 2016 Study Status, Sponsor/Collaborators, Contacts/Locations and Arms and Interventions
4 May 5, 2017 Study Status, Oversight, IPDSharing and Contacts/Locations
5 March 28, 2018 Study Status
6 June 20, 2018 Study Status
7 November 1, 2018 Study Status
8 March 11, 2019 Study Status
9 September 27, 2019 Study Status
10 February 19, 2021 Recruitment Status, Study Status, IPDSharing, Contacts/Locations and Study Design
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Study NCT02434965
Submitted Date:  April 30, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: NYMC-554
Brief Title: Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy (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)
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Not yet recruiting
Study Start: June 2015
Primary Completion: December 2017 [Anticipated]
Study Completion: December 2019 [Anticipated]
First Submitted: April 27, 2015
First Submitted that
Met QC Criteria:
April 30, 2015
First Posted: May 6, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 30, 2015
Last Update Posted: May 6, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: New York Medical College
Responsible Party: Sponsor
Collaborators: Celgene Corporation
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: Severe Hypoxic-ischemic Encephalopathy
Keywords: Neonates
hypoxic-ischemic encephalopathy
human placental-derived stem cells
autologous
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
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 7.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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:
1. 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.
Open or close this module Eligibility
Minimum Age: 1 Minute
Maximum Age: 6 Hours
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Mitchell S Cairo, MD
Telephone: 914-594-2150
Email: mitchell_cairo@nymc.edu
Central Contact Backup: Erin Morris, RN
Telephone: 714-964-5359
Email: erin_morris@nymc.edu
Study Officials: Mitchell S Cairo, MD
Principal Investigator
New York Medical College
Locations: United States, New York
New York Medical College
Vallhala, New York, United States, 10595
Contact:Contact: Mitchell S Cairo, MD 914-594-2150 mitchell_cairo@nymc.edu
Contact:Contact: Phyllis Brand, RN, MPH 914-594-2144 phyllis_brand@nymc.edu
Contact:Principal Investigator: Mitchell S. Cairo, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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