3251 · Bladder issues due to Spinal Cord Injury (Ages 18-75) · SS

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This study is expected to run until mid to late August 2026

Live Geos:

https://partners.subjectwell.com/publishers/geos_report/7704bccb-a4a1-4e1d-b7d1-768fe8a89b91

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Ages: 18-75

Gender: All

Study Description:

This study will be focused on people with neurogenic bladder due to spinal cord injury. It will be enrolling participants who are living with chronic involuntary bladder leakages (experiencing several episodes per week) despite their current treatments. This is an early phase study for a specially designed and targeted investigational product. This product is a designed, new gene therapy Herpes Simplex Virus-1 vector (i.e. transporter) delivering a study drug targeting specific nerves close to the spinal cord which controls the bladder. The vector is modified to be non-replicative, meaning it cannot multiply in the body. The investigational product may provide relief for the bladder leakages, potentially lasting for several years after only one treatment. The study drug will be administered as a one-time treatment at the clinic via cystoscopy, an instrument used to look into the bladder, under local anesthesia. After the administration, the participants will be admitted for one night to the clinic for observation. During screening, there will be 2 outpatient visits to the clinic. Total study duration, after the study drug administration, is approximately 52 weeks with 7 out-patient visits. After the study, participants will be asked to enter a long-term safety follow-up study (5 years) with bi-annual remote and clinic visits. Study procedures and tests will include vital signs, urodynamics (measurements of bladder pressures), bladder diary completion, laboratory tests, and quality of life questionnaires.  Patients and patient caregivers may be reimbursed for reasonable expenses such as travel, meal, and accommodation costs for attending the study visits.

Study Breakdown:

Medical indications: Spinal Cord Injury (SCI), Overactive Bladder

Exclusionary indications: Multiple Sclerosis (MS), Parkinson's Disease, Encephalitis

Amount of visits: Up to 9 visits

Length of the study: approximately 52 weeks

Medication type: Injectable

Doses: One treatment course

Compensation: N/A

Qualifications:

• Patient had a supra-sacral traumatic spinal cord injury (SCI), which means a cervical, thoracic or lumbar spinal cord injury, at least one year ago, but not longer than 12 years ago
• Patient diagnosed with neurogenic bladder and urinary incontinence for at least 3 months and has at least 8 episodes of involuntary urinary leakage /week
• Patient routinely performing clean intermittent catheterization (CIC) (at least 4 times a day)
• Patient cannot also be diagnosed with Multiple Sclerosis (MS), Parkinson's Disease, Encephalitis