Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct

Conditions

• Contracted Bladder

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• "Neo-Bladder" Construct — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Sep 2025

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Autologous "Neo-Bladder" Construct
  All subjects enrolled 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.

Primary Outcome Measure

Bladder Compliance Average [ Time Frame: Month 12 ]

Central Contacts

• Mary-Clare Day, RN, BSN
  336-713-1343
  [email protected]

Locations (1)

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