Actively Recruiting

Age: 0Years - 15Years
All Genders
ID06590142

Investigating the Interaction of the Enteric Nervous System With the Extrinsic Nervous System and the Immune System in Children and Development of Cell Therapies for Hirschsprung's Disease

Led by Alder Hey Children's NHS Foundation Trust · Updated on 2024-09-19

300

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

A

Alder Hey Children's NHS Foundation Trust

Lead Sponsor

U

University of Liverpool

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating Hirschsprung's Disease (HSCR), a condition where children lack normal nerve cells in the lower bowel, causing serious health risks if untreated. The study focuses on understanding how nerve stem cells from affected bowel areas may grow and develop, aiming to find new treatments that could avoid surgery and the need for a permanent stoma. This observational study explores nerve cell development and interactions in children with HSCR to improve future therapies. The study collects bowel tissue samples from children with HSCR, including both affected (aganglionic) and normal (ganglionic) bowel segments, as well as from children without HSCR undergoing bowel surgery. Researchers examine nerve stem cells grown in the lab as neurospheres to observe their growth and response to medications that might encourage nerve development. The study includes analyzing cells from the transition zone of the bowel to assess their potential for use in future cell therapies. During the study, participants will have their bowel tissue collected during therapeutic intestinal surgery, with no additional tissue removed for research. The main measurement is the successful optimization of a protocol to analyze single cells from human bowel tissue by March 2026. Researchers will study the nerve cells' growth, differentiation, and interactions, combining clinical and patient data. Participation involves no interventions beyond routine surgery, and the study will monitor outcomes to support the development of future treatments for HSCR. The study is expected to continue until March 2036.

CONDITIONS

Brief Title

Hirschsprung's Advances; Working Towards Autologous tIssue therapIes

Who Can Participate

Age: 0Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Any child undergoing therapeutic intestinal resection where not all tissue must be sent for histopathology
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of surgery

Participants undergo tissue specimen collection during therapeutic intestinal resection surgery.

1 visit (in-person during surgery)

Long-term Monitoring

Duration - Up to 12 years

Participants are observed for long-term outcomes related to Hirschsprung's disease without active intervention.

Follow-up visits as part of routine care

Trial Site Locations

Total: 1 location

1

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, United Kingdom, L12 2AP

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Research Team

R

Rachel Harwood, MBBS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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