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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Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Cornelia Haag-Molkenteller, MD · STUDY_DIRECTOR · Cyllene Therapeutics
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- 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)