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

• ClinicalTrials.gov Identifier: NCT02434965
• Recruitment Status: Withdrawn
• First Posted: May 6, 2015
• Last Update Posted: February 23, 2021
• Sponsor: New York Medical College
• Collaborator: Celgene
• Information provided by (Responsible Party): New York Medical College

Tracking Information

• First Submitted Date: April 27, 2015
• First Posted Date: May 6, 2015
• Last Update Posted Date: February 23, 2021
• Estimated Study Start Date: December 2019
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 30, 2015)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 30, 2015)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy
• 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)
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
• 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.

Study Arms

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.

Interventions:

• Drug: HPDSC
• Drug: Cord blood

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: February 19, 2021): 0
• Original Estimated Enrollment (submitted: April 30, 2015): 20
• Estimated Study Completion Date: January 2022
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 6 Hours (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02434965
• Other Study ID Numbers: NYMC-554
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Study not enrolling

• Current Responsible Party: New York Medical College
• Original Responsible Party: Same as current
• Current Study Sponsor: New York Medical College
• Original Study Sponsor: Same as current
• Collaborators: Celgene

Investigators

• Principal Investigator: Mitchell S Cairo, MD; New York Medical College

• PRS Account: New York Medical College
• Verification Date: September 2019