Actively Recruiting
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
Led by Noveome Biotherapeutics, formerly Stemnion · Updated on 2026-04-13
36
Participants Needed
8
Research Sites
271 weeks
Total Duration
On this page
Sponsors
N
Noveome Biotherapeutics, formerly Stemnion
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.
CONDITIONS
Official Title
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born from 62;22 weeks gestational age up to and including 40 weeks gestational age; up to 40 weeks postmenstrual age with weight at NEC diagnosis between 62;500g and 62;3000g
- Bell's Stage IIA or higher medical NEC diagnosis confirmed by radiologic imaging showing pneumatosis intestinalis
- Parent or legal representative provides written consent before enrollment
You will not qualify if you...
- Infants with abdominal perforation
- Infants not expected to survive 2 weeks or born with lethal conditions requiring hospice or palliative care
- Infants born with major congenital anomalies such as cardiac defects or chromosomal disorders
- Mother's receipt of any investigational product during pregnancy
- Infants with malignancies such as solid tumors or blood neoplasms
- Infants with hypercoagulability disorders or diagnosed coagulation problems
- Infants with known immunodeficiency conditions
- Infants with anatomic defects requiring surgery
- Infants with persistent pulmonary hypertension of the newborn
- Infants with gastrointestinal conditions preventing feeding within 7 days after birth
- Infants with hypoxic ischemic injury (perinatal asphyxia)
- Infants with polycythemia (hemoglobin >22 g/dL) at treatment time
- Infants with positive maternal HIV status
- Infants born to mothers with history of drug abuse (excluding marijuana and prescribed drug abuse treatments)
- Infants considered unsuitable for the study by the Investigator
- Infants diagnosed with NEC who require immediate surgical intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
BayCare Health System-St. Joseph's Women's Hospital
Tampa, Florida, United States, 33607
Actively Recruiting
5
NorthShore University-Evanston Hospital
Evanston, Illinois, United States, 60201
Actively Recruiting
6
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
7
Penn State Health Milton S Hershey Medical Center/Penn State University College of Medicine
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
8
University of Pittsburgh Medical Center Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
Research Team
K
Karin Potoka, MD
CONTACT
S
Shawna M Rose, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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