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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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 36 weeks of age and at discharge from nicu - up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 36 weeks of age and at discharge from nicu - up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreOther study objectives
Exploratory endpoint: All cause mortality
Exploratory endpoint: Change in head circumference over time
Exploratory endpoint: Change in length over time
+14 moreSide effects data
From 2017 Phase 2 trial • 151 Patients • NCT027619936%
Sensitivity of teeth
6%
Blood pressure increased
4%
Palatal disorder
4%
Gingival erythema
4%
Dental fistula
4%
Toothache
4%
Burn oral cavity
4%
Tooth fracture
4%
Thermal burn
4%
Gingival pain
2%
Pancreatic carcinoma
2%
Nasopharyngitis
2%
Cholecystitis
2%
Mouth injury
2%
Lip haematoma
2%
Dental discomfort
2%
Gingival oedema
2%
Hypoaesthesia oral
2%
Blood pressure diastolic decreased
2%
Lip injury
2%
Dyspepsia
2%
Headache
2%
Dry mouth
2%
Lip swelling
2%
Oral mucosal discolouration
2%
Influenza
2%
Tooth loss
2%
Gastroenteritis viral
2%
Angular cheilitis
2%
Gastroenteritis norovirus
2%
Pneumonia
2%
Muscle strain
2%
Contusion
2%
Blood pressure decreased
2%
Lymphocyte count increased
2%
Monocyte count decreased
2%
Neutrophil count decreased
2%
White blood cell count decreased
2%
Pain in jaw
2%
Arthralgia
2%
Dizziness
2%
Device damage
2%
Adverse drug reaction
2%
Complication associated with device
2%
Oral disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 3
Group 1
Group 2
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
314 Previous Clinical Trials
96,750 Total Patients Enrolled