Trials Sponsors Conditions Drugs Pricing

Conditions

Severe Hypoxic-ischemic Encephalopathy

Keywords

Neonateshypoxic-ischemic encephalopathyhuman placental-derived stem cellsautologous

Outcome Measures

Primary Outcomes (1)

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
within the first 30 days

Secondary Outcomes (1)

Improvement in neurological condition
2 years post HPDSC infusion

Study Arms (1)

Autologous Cord Blood and HPDSC

EXPERIMENTAL

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: HPDSCDrug: Cord blood

Interventions

HPDSCDrug

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.

Autologous Cord Blood and HPDSC

Cord bloodDrug

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.

Eligibility Criteria

Age1 Minute - 6 Hours

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Gestational age ≥ 36 weeks
Birth weight ≥ 1800 grams

Sponsors & Collaborators

New York Medical College
Otherlead
Celgene
Industrycollaborator

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Mitchell S Cairo, MD
New York Medical College
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 6, 2015

Study Start

December 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Autologous Cord Blood and HPDSC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Autologous Cord Blood and HPDSC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations