Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy (HPDSC+HIE)
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|ClinicalTrials.gov Identifier: NCT02434965|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2015
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Severe Hypoxic-ischemic Encephalopathy||Drug: HPDSC Drug: Cord blood||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2022|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434965
|Contact: Mitchell S Cairo, MDfirstname.lastname@example.org|
|Contact: Erin Morris, RNemail@example.com|
|United States, New York|
|New York Medical College|
|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|