A Phase 2 Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct In Subjects With Fibrotic Contracted Bladder
Wake Forest University Health Sciences
Summary
The purpose of this research study is to find out if autologous "neo-bladder" construct for the treatment of fibrotic and/or contracted bladder can improve bladder compliance and be safe long term. The neo-bladder is like a reservoir or pouch that will be surgically attached to the bladder to assist with urine collection.
Description
This is a prospective, open-label, single-group clinical study. All subjects will have non-neurogenic, fibrotic contracted bladder that is refractory to medical treatment and require augmentation cystoplasty for preventing long-term sequelae (i.e., kidney failure) that result from persistently high intravesical pressure. Subjects will undergo an open full thickness bladder biopsy from which autologous urinary bladder smooth muscle and urothelial cells will be procured and expanded ex vivo. After approximately 5 - 7 weeks, expanded cells will be seeded on a biodegradable scaffold to produce the…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects with small contracted and/or fibrotic non-neurogenic bladder. * Small bladder \<150cc capacity * Willing and able to give signed informed consent in English. * Ability of subject to be successfully trained in clean intermittent catheterization and bladder cycling * Failure to respond to maximum approve dose of medical therapy (e.g. anticholinergics) or failure to tolerate /contraindication to such agents * Medical need for bladder augmentation, as defined by the presence of: 1. Decreased and inadequate bladder compliance with a bladder pressure ≥40 cmH20. OR…
Interventions
- Biological"Neo-Bladder" Construct
Subjects will undergo an open full thickness bladder biopsy from which autologous urinary bladder smooth muscle and urothelial cells will be procured and expanded ex vivo. After approximately 5 - 7 weeks, expanded cells will be seeded on a biodegradable scaffold to produce the neo-bladder construct that will be surgically implanted onto an opened native bladder during an augmentation cystoplasty.
Location
- Atrium Health Wake Forest BaptistWinston-Salem, North Carolina