Muscle Derived Cell Therapy for Bladder Exstrophy Epispadias Induced Incontinence

Exclusion criteria

• . Urodynamic study demonstrating severe uninhibited bladder contractions.
• . Severe urethral or bladder neck stricture demonstrated during screening cystoscopy or cystogram
• . Cystography at the time of screening demonstrating Grade IV vesicoureteral reflux (high-grade reflux with dilation of the renal pelvis and blunting or the fornices) or Grade V vesicoureteral reflux (Grade IV findings plus loss of the papillary impression and ureteral tortuosity).
• . Any degree of renal scarring at the time of screening as demonstrated by DMSA or MAG3 renal scintigraphy in the presence of any grade of vesicoureteral reflux (VUR)
• . Renal ultrasound demonstrating Society of Fetal Urology Grade III hydronephrosis (widely split renal pelvis, renal calices uniformly dilated, no parenchymal thinning) or Grade IV hydronephrosis (Grade III dilation plus parenchymal thinning). See Appendix D.
• . Previous injection of bulking agents at the level of the bladder neck (bovine collagen or DEFLUX™)
• . Positive urine culture resistant to preoperative oral antibiotic therapy
• . Need for chronic or pulse steroids or history of other congenital or acquired condition that results in immunocompromise