A Phase 2 interventional study of Infusion of autologous cord blood and Placebo in Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns, sponsored by Michael Cotten. Completed at 1 site in United States. Open to participants aged 0 Hours to 6 Hours. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Michael Cotten · Phase 2, Interventional, and Treatment
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
The purpose of this phase II study is to assess the safety and efficacy of up to two intravenous infusions of autologous volume and red blood cell reduced nucleated umbilical cord blood cells as compared with placebo in neonates with neonatal encephalopathy undergoing hypothermia treatment. Efficacy will be estimated by one year survival and score on Bayley III scores in all three domains equal to or greater than 85. This will be a randomized, double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for cooling.
758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.
This study's enrollment of 35 is below the median of 58 across 454 interventional studies indexed under Brain Diseases.
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Exclusion Criteria:
Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
Biological: Infusion of autologous cord blood
Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
Biological: Placebo
Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.
Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.
Survival at One Year
Number of participants alive at one year.
Time frame: 1 year
Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85
The Bayley is a standardized, norm-referenced measure that assesses development in Cognitive, Language and Motor domains. Composite standard scores can be derived that have a mean of 100 and a standard deviation of 15.
Time frame: 1 year
Mortality Rate
(Number of participants who died/total number of participants) x 100
Time frame: 1 year
Number of Subjects Who Experience Seizures
Time frame: During hospitalization, approximately 4-92 days
Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use
Time frame: During hospitalization, approximately 4-92 days
Number of Subjects Who Require ECMO
ECMO (extracorporeal membrane oxygenation) is a technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion to sustain life.
Time frame: During hospitalization, approximately 4-92 days
Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding
Time frame: During hospitalization, approximately 4-92 days
Number of Subjects Who Are Discharged on Anti-epileptic Medication
Time frame: At hospital discharge, approximately 4-92 days
| Milestone | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Started | 17 | 18 |
| Completed | 14 | 15 |
| Not completed | 3 | 3 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 2 |
Number of participants alive at one year.
| Participants | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Survival at One Year | 16 | 17 |
The Bayley is a standardized, norm-referenced measure that assesses development in Cognitive, Language and Motor domains. Composite standard scores can be derived that have a mean of 100 and a standard deviation of 15.
| Participants | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85 | 12 | 6 |
(Number of participants who died/total number of participants) x 100
| percentage of participants | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Mortality Rate | 5.88 | 5.56 |
| Participants | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Number of Subjects Who Experience Seizures | 6 | 6 |
| Participants | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use | 3 | 2 |
ECMO (extracorporeal membrane oxygenation) is a technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion to sustain life.
| Participants | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Number of Subjects Who Require ECMO | 0 | 0 |
| Participants | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding | 2 | 3 |
| Participants | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Number of Subjects Who Are Discharged on Anti-epileptic Medication | 2 | 1 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Cell Recipients | 1/17 (5.9%) | 1/17 (5.9%) | 1/17 (5.9%) |
| Placebo Recipients | 1/18 (5.6%) | 2/18 (11.1%) | 3/18 (16.7%) |
| Event | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| Death neonatalGeneral disorders | 1/17 | 1/18 |
| Necrotizing EnterocolitisGastrointestinal disorders | 0/17 | 1/18 |
| Event | Intervention Cell Recipients | Placebo Recipients |
|---|---|---|
| SeizuresNervous system disorders | 0/17 | 2/18 |
| Cord blood positive cultureInfections and infestations | 1/17 | 0/18 |
| HypertensionCardiac disorders | 0/17 | 1/18 |
| Age, Categorical(Participants) | Intervention Cell Recipients | Placebo Recipients | Total |
|---|---|---|---|
| <=18 years | 17 | 18 | 35 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Intervention Cell Recipients | Placebo Recipients | Total |
|---|---|---|---|
| Female | 8 | 9 | 17 |
| Male | 9 | 9 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Cell Recipients | Placebo Recipients | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 16 | 17 | 33 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Cell Recipients | Placebo Recipients | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 8 | 14 |
| White | 8 | 7 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Region of Enrollment(Participants) | Intervention Cell Recipients | Placebo Recipients | Total |
|---|---|---|---|
| United States | 17 | 18 | 35 |
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