Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy (HPDSC+HIE)
|Severe Hypoxic-ischemic Encephalopathy||Drug: HPDSC Drug: Cord blood||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
- 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
- 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.
|Anticipated Study Start Date:||August 2017|
|Estimated Study Completion Date:||June 2020|
|Estimated Primary Completion Date:||June 2019 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02434965
|Contact: Mitchell S Cairo, MDfirstname.lastname@example.org|
|Contact: Erin Morris, RNemail@example.com|
|United States, New York|
|New York Medical College||Not yet recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Mitchell S Cairo, MD 914-594-2150 firstname.lastname@example.org|
|Principal Investigator: Mitchell S. Cairo, MD|
|Principal Investigator:||Mitchell S Cairo, MD||New York Medical College|