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

Part of paid clinical trials in Downey, California.

Sponsor
EG 427
Study ID
NCT07227285
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Spinal Cord Injury
  • Urinary Bladder, Overactive

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Urodynamics — OTHER
    standardized local evaluation of urodynamic parameters
  • EG110A — DRUG
    Patients already treated with EG110A
  • Patient-reported Outcome — OTHER
    assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms

Study Details

The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose/injection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.

Key Dates

Start date
Apr 30, 2026
Status verified
Nov 2025
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Patients who received EG110A in a clinical study, regardless of dose

Primary Outcome Measure

Incidence of treatment emergent serious adverse events (TESAEs) [ Time Frame: 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Rancho Los Amigos National Rehabilitation CenterDowneyCalifornia90242
Evgeniy Kreydin, MD
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
John Stoffel, MD
Sidney Kimmel Medical CollegePhiladelphiaPennsylvania19107
Patrick Shenot, MD
UTHealth Houston / TIRR Memorial HermannHoustonTexas77030
Argyrios Stampas, MD

Find similar trials in Downey, CA

By research site
Rancho Los Amigos National Rehabilitation Center· Downey, CAUniversity of Michigan Rogel Cancer Center· Ann Arbor, MISidney Kimmel Medical College· Philadelphia, PAUTHealth Houston / TIRR Memorial Hermann· Houston, TX

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