Severe Hypoxic-ischemic EncephalopathyPhase 2HPDSC+HIENCT02434965
Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy
A Phase 2 study testing HPDSC and Cord blood in people with Severe Hypoxic-ischemic Encephalopathy, run by New York Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 6 hours
- Conditions the study is for
- Severe Hypoxic-ischemic Encephalopathy
- What is being tested?
- HPDSC and Cord blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2019to Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Severe Hypoxic-ischemic Encephalopathy
- Being tested
- HPDSC, Cord blood
- Keywords
- Neonates, hypoxic-ischemic encephalopathy, human placental-derived stem cells, autologous
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HPDSC; Drug: Cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within the first 30 days
Secondary outcomes (1)
Improvement in neurological condition
Improvement in neurological condition as shown on head MRI, DTI and neurological development by Sarnat testing.
Measured: 2 years post HPDSC infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startDec 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Hypoxic-ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Mitchell S Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434965
- Sponsor's protocol ID
- NYMC-554
- Acronym
- HPDSC+HIE
- Status last verified
- Sep 2019
- First submitted
- 27 Apr 2015
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study not enrolling
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02434965
- Acronym / sponsor ID
- HPDSC+HIE / NYMC-554
- Conditions
- Severe Hypoxic-ischemic Encephalopathy
- Keywords
- Neonates, hypoxic-ischemic encephalopathy, human placental-derived stem cells, autologous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Dec 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Cord Blood and HPDSC | Experimental | Drug: HPDSC, Drug: Cord bloodAutologous cord blood and placental blood will be collected after birth of child and administered in divided aliquots during the first week of life. |
Who may qualify
- Ages
- 1 minute to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPDSCAutologous 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 | Autologous Cord Blood and HPDSC |
| Cord bloodAutologous 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. | Drug | Autologous Cord Blood and HPDSC |
Primary outcome
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
1 secondary outcome
Improvement in neurological condition
Time frame: 2 years post HPDSC infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No. Study not enrolling
Related trials for Severe Hypoxic-ischemic Encephalopathy
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Feasibility and Safety of Intranasally Administered Breast Milk in HIE
Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell S Cairo, MD principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HPDSC and Cord blood in people with Severe Hypoxic-ischemic Encephalopathy, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with infusion reaction as a measure of safety and tolerability (time frame: within the first 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.