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Stem Cell Therapy
Cohort 3 - lower dose active + SOC treatment vs. SOC alone in lower weight range 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
Study 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 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
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 moreOther outcome measures
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%
Burn oral cavity
4%
Palatal disorder
4%
Toothache
4%
Gingival erythema
4%
Dental fistula
4%
Tooth fracture
4%
Thermal burn
4%
Gingival pain
2%
Adverse drug reaction
2%
Monocyte count decreased
2%
Blood pressure decreased
2%
Tooth loss
2%
Complication associated with device
2%
White blood cell count decreased
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
304 Previous Clinical Trials
101,116 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial open to individuals younger than 85 years old?
"Participants in this research must be between 2 and 8 weeks old. Notably, there are a total of 24 trials catering to individuals under 18 years of age and an additional seven for those above the age of 65."
Answered by AI
Is the enrollment process currently open for this research study?
"Indeed, the details on clinicaltrials.gov indicate an ongoing search for participants in this study. The trial first appeared online on March 29th, 2024 and saw its latest update on April 1st of the same year. Specifically, the research aims to enroll a total of 36 patients at one designated site."
Answered by AI
What is the total number of participants being recruited for this research endeavor?
"Indeed, the details on clinicaltrials.gov indicate that this investigation is actively seeking participants. The trial was initially listed on March 29th, 2024 and most recently revised on April 1st, 2024. A total of 36 individuals are sought from a singular site."
Answered by AI
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