Clinical trial

A Phase I Study of hCT-MSC, an Umbilical Cord-Derived Mesenchymal Stromal Cell Product, in Newborn Infants With Moderate or Severe Hypoxic- Ischemic Neonatal Encephalopathy.

NCT03635450

Name

Pro00100253

Description

To determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.

Trial arms

Trial start

2018-12-27

Estimated PCD

2019-07-28

Trial end

2020-12-28

Status

Completed

Phase

Early phase I

Treatment

Infusion of hCT-MSC

Infants who meet enrollment criteria for moderate to severe hypoxic ischemic encephalopathy will receive 1 infusion of hCT-MSC within the first 48 postnatal hours. hCT-MSCs are a product of allogeneic cells manufactured from digested umbilical cord tissue that is expanded in culture, cryopreserved and banked. hCT-MSCs are manufactured from umbilical cord tissue donated to the Carolinas Cord Blood Bank, an FDA-licensed, FACT-accredited, public cord blood bank at Duke University Medical Center, after written informed consent from the baby's mother. Cord tissue is harvested from the placentas of male babies delivered by elective C-section after a normal, full- term pregnancy.

Arms:

First cohort of 3 subjects enrolled, Second cohort of 3 subjects enrolled

Size

Primary endpoint

Incidence of infusion reactions

24 hours after each infusion

Incidence of Infections post-infusion

Up to 2 Weeks

Eligibility criteria

Inclusion Criteria: * 36 0/7th weeks gestation or older at the time of delivery. * Able to receive one dose of hCT-MSCs in the first 48 postnatal hours * Willingness to return for one year assessments. * Signs of encephalopathy within 6 hours of age Exclusion Criteria: * Major congenital or chromosomal abnormalities * Severe growth restriction (birth weight \<1800 g) * Opinion by attending neonatologist that the study may interfere with clinical treatment or safety of subject * Moribund neonates for whom no further treatment is planned * Infants whose mothers have unknown serologies for Hepatitis B or HIV * Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy * Infants suspected of overwhelming sepsis * ECMO initiated or likely in the first 48 hours of life * Mother suspected to have intraamniotic infection at time of birth. * ALL blood gases (cord and postnatal) done within the first 60 minutes had a pH \> 7.15 AND base deficit \< 10 mEq/L (source can be arterial, venous or capillary) * Mother with documented Zika infection during this pregnancy * Availability of autologous cord blood collected and usable in the randomized trial of autologous volume- and red blood cell-reduced cord blood cells (Duke IRB Pro00066647; clinical trials.gov link: https://clinicaltrials.gov/ct2/show/NCT02612155 )

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The first cohort of three patients will receive a single dose in the first 48 postnatal hours. If there are no safety concerns, the second cohort of three patients will receive two doses, with the first dose given in the first 48 postnatal hours and the second dose given approximately two months after the first dose.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

Updated at

2024-04-12

1 organization

Organization

Joanne Kurtzberg