← Back to Search

Stem Cell Therapy

ST266 for Necrotizing Enterocolitis

Phase 1 & 2
Recruiting
Research Sponsored by Noveome Biotherapeutics, formerly Stemnion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 36 weeks of age and at discharge from nicu - up to 6 months
Awards & highlights

Summary

This trial aims to test the safety and effectiveness of two different doses of ST266 given once a day through an IV to treat patients with Bell's stage IIA or higher NEC. The main goal is

Who is the study for?
This trial is for premature infants between 26 and 36 weeks of gestational age, weighing between 800g and 3000g, diagnosed with at least Bell stage IIA Necrotizing Enterocolitis (NEC), confirmed by specific radiologic signs. Parents or legal guardians must consent to the infant's participation.Check my eligibility
What is being tested?
The study tests two doses (0.5 mL/kg and 1.0 mL/kg) of ST266 given once daily through an IV to see if it's safe and can be tolerated in treating NEC in infants. It also looks at how effective these doses are against NEC.See study design
What are the potential side effects?
Potential side effects will be monitored through treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Specific side effects aren't listed but would include any negative reactions observed during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 36 weeks of age and at discharge from nicu - up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 36 weeks of age and at discharge from nicu - up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression
Safety and Tolerability endpoint: incidence of adverse events
Safety and Tolerability endpoint: incidence of serious adverse events
Secondary outcome measures
Efficacy endpoint: Change in Neonatal Sequential Organ Failure Assessment (nSOFA) score
Efficacy endpoint: Incidence of abdominal surgical intervention
Efficacy endpoint: Time to full enteral nutrition assessment
+1 more
Other outcome measures
Exploratory endpoint: All cause mortality
Exploratory endpoint: Change in head circumference over time
Exploratory endpoint: Change in length over time
+14 more

Side effects data

From 2017 Phase 2 trial • 151 Patients • NCT02761993
6%
Sensitivity of teeth
6%
Blood pressure increased
4%
Burn oral cavity
4%
Palatal disorder
4%
Toothache
4%
Gingival erythema
4%
Dental fistula
4%
Tooth fracture
4%
Thermal burn
4%
Gingival pain
2%
White blood cell count decreased
2%
Adverse drug reaction
2%
Monocyte count decreased
2%
Tooth loss
2%
Blood pressure decreased
2%
Complication associated with device
2%
Muscle strain
2%
Lip swelling
2%
Hypoaesthesia oral
2%
Pneumonia
2%
Pancreatic carcinoma
2%
Cholecystitis
2%
Nasopharyngitis
2%
Mouth injury
2%
Lip injury
2%
Blood pressure diastolic decreased
2%
Headache
2%
Dental discomfort
2%
Dry mouth
2%
Dyspepsia
2%
Gingival oedema
2%
Lip haematoma
2%
Oral mucosal discolouration
2%
Gastroenteritis viral
2%
Influenza
2%
Angular cheilitis
2%
Gastroenteritis norovirus
2%
Contusion
2%
Lymphocyte count increased
2%
Neutrophil count decreased
2%
Pain in jaw
2%
Arthralgia
2%
Dizziness
2%
Device damage
2%
Oral disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 3
Group 1
Group 2

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4 - higher dose active + SOC treatment vs. SOC alone in lower weight rangeExperimental Treatment1 Intervention
Infants with birth weight ≥800 g and ≤999 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)
Group II: Cohort 3 - lower dose active + SOC treatment vs. SOC alone in lower weight rangeExperimental Treatment1 Intervention
Infants with birth weight ≥800 g and ≤999 g; 0.5 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)
Group III: Cohort 2 - higher dose active + SOC treatment vs. SOC alone in higher weight rangeExperimental Treatment1 Intervention
Infants with birth weight ≥1000 g and ≤3000 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)
Group IV: Cohort 1 - lower dose active + SOC treatment vs. SOC alone in higher weight rangeExperimental Treatment1 Intervention
Infants with birth weight ≥1000 g and ≤3000 g; 0.5 mL/kg of ST266, QD, + Standard of Care (SOC) treatment (n=6); SOC (n=3)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ST266
2016
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Noveome Biotherapeutics, formerly StemnionLead Sponsor
12 Previous Clinical Trials
394 Total Patients Enrolled
ParexelIndustry Sponsor
306 Previous Clinical Trials
101,047 Total Patients Enrolled
~24 spots leftby Dec 2026