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

Primary Purpose

Severe Hypoxic-ischemic Encephalopathy

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HPDSC
Cord blood
Sponsored by
New York Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Hypoxic-ischemic Encephalopathy focused on measuring Neonates, hypoxic-ischemic encephalopathy, human placental-derived stem cells, autologous

Eligibility Criteria

1 Minute - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Cord Blood and HPDSC

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in neurological condition
Improvement in neurological condition as shown on head MRI, DTI and neurological development by Sarnat testing.

Full Information

First Posted
April 27, 2015
Last Updated
February 19, 2021
Sponsor
New York Medical College
Collaborators
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02434965
Brief Title
Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study not started
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Medical College
Collaborators
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypoxic-ischemic Encephalopathy
Keywords
Neonates, hypoxic-ischemic encephalopathy, human placental-derived stem cells, autologous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Cord Blood and HPDSC
Arm Type
Experimental
Arm Description
Autologous cord blood and placental blood will be collected after birth of child and administered in divided aliquots during the first week of life.
Intervention Type
Drug
Intervention Name(s)
HPDSC
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cord blood
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of subjects with infusion reaction as a measure of safety and tolerability
Description
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
Time Frame
within the first 30 days
Secondary Outcome Measure Information:
Title
Improvement in neurological condition
Description
Improvement in neurological condition as shown on head MRI, DTI and neurological development by Sarnat testing.
Time Frame
2 years post HPDSC infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S Cairo, MD
Organizational Affiliation
New York Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study not enrolling

Learn more about this trial

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

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