Long-term Follow-up for EG110A Gene Therapy in Overactive Bladder and Spinal Cord Injury

This study is a long-term follow-up for people who have already received EG110A, a gene therapy derived from the Herpes Simplex Virus 1. It aims to understand how EG110A is tolerated over five years, including any side effects, and to see how well it works for conditions like overactive bladder and spinal cord injury. You can join if you are between 18 and 75 years old and have already received at least one dose of EG110A in a previous study (EG110A-001-01). The main goals are to track any serious or other side effects for up to five years after your last dose. The study's current status is unclear.

Study design
This is an interventional study with a planned enrollment of 16 participants. It is a long-term follow-up for individuals who previously received EG110A.
What's involved
You would undergo standardized local evaluations of bladder function (urodynamics) and complete questionnaires about your symptoms. This follow-up will continue for five years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for five years to monitor for adverse events and long-term effectiveness.

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NCT07227285

Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy

Not Yet Recruiting
PHASE1Ages 18–75Interventional
Cyllene Therapeutics
~16 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:UrodynamicsEG110APatient-reported Outcome

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment emergent serious adverse events (TESAEs)
Measured over 5 years
+1 more outcome measured
Urinary Bladder, Overactive
Spinal Cord Injury
4 sites across 4 states
California1
Michigan1
Pennsylvania1
Texas1
  • Cornelia Haag-Molkenteller, MD · STUDY_DIRECTOR · Cyllene Therapeutics

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Eligibility criteria

Exclusion

Participant plans to participate in another investigational gene therapy study
Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator
  • Incidence of treatment emergent serious adverse events (TESAEs)5 years

    Any participant who has a reported treatment emergent serious adverse event (TESAE)

  • Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs)5 years

    Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)