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Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

Sponsored by Noveome Biotherapeutics, formerly Stemnion

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified May 22, 2025

Phase

Clinical Trial

Sponsor

Noveome Biotherapeutics, formerly Stemnion

Enrollment Target

36

Start Date

Aug 2024

๐Ÿ“Š
1 of 36 participants interested
3% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Infants born from โ‰ฅ26 weeks gestational age to 40 weeks gestational age; up to 40 weeks postmenstrual gestational age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between โ‰ฅ800g and โ‰ค3000g as a result of prematurity and/or IUGR. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment. 2. Minimum Bell stage IIA NEC diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus.

Exclusion Criteria

Infants with abdominal perforation at less than 10 days of life 2. Not expected to survive โ‰ฅ2 weeks or born with a lethal condition requiring hospice or palliative care (e.g., disease has progressed to NEC totalis, or patient has multi-organ system failure). 3. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect). 4. Mother's r

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

36 participants

๐ŸŽ‚

Age Range

2 Weeks - 8 Weeks

โšง

Gender

ALL

๐Ÿข

Sponsor

Noveome Biotherapeutics, formerly Stemnion

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

New Haven

Connecticut

Location available
View New Haven location page
ACTIVE_NOT_RECRUITING

Orlando

Florida

Location available
View Orlando location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Evanston

Illinois

Location available
View Evanston location page
ACTIVE_NOT_RECRUITING

Durham

North Carolina

Location available
View Durham location page
RECRUITING

Oklahoma City

Oklahoma

Location available
View Oklahoma City location page
RECRUITING

Pittsburgh

Pennsylvania

Location available
View Pittsburgh location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

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Looking for Necrotizing Enterocolitis Treatment in New Haven?

Join others in Connecticut exploring innovative treatment options through clinical research

Necrotizing Enterocolitis Treatment Options in New Haven, Connecticut

If you're searching for Necrotizing Enterocolitis treatment in New Haven, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in New Haven, Orlando, Tampa and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Necrotizing Enterocolitis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Connecticut
Now Enrolling
Up to 36 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Necrotizing Enterocolitis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Necrotizing Enterocolitis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Necrotizing Enterocolitis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06315738. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.