Clinical trial NCT02434965: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Severe Hypoxic-ischemic Encephalopathy
Keywords: Neonates
hypoxic-ischemic encephalopathy
human placental-derived stem cells
autologous
Lead sponsor: New York Medical College
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2015-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of subjects with infusion reaction as a measure of safety and tolerability
timeFrame: within the first 30 days
Secondary outcomes:
measure: Improvement in neurological condition
timeFrame: 2 years post HPDSC infusion
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Mitchell S Cairo, MD
role: PRINCIPAL_INVESTIGATOR
References: