News Column

Recent Studies from Wake Forest Baptist Medical Center Add New Data to Clinical Trials and Studies

June 4, 2014



By a News Reporter-Staff News Editor at Biotech Week -- Investigators publish new report on Clinical Research. According to news reporting originating in Winston Salem, North Carolina, by NewsRx journalists, research stated, "Augmentation cystoplasty using gastrointestinal segments in children/adolescents with medically refractory neurogenic bladder is associated with significant complications. We evaluated an autologous cell seeded biodegradable scaffold (Tengion ) for bladder augmentation as an alternative to traditional enterocystoplasty in this population."

The news reporters obtained a quote from the research from Wake Forest Baptist Medical Center, "A phase II prospective study was performed in children with neurogenic bladder due to spina bifida requiring enterocystoplasty for detrusor pressure 40 cm H2O or greater despite maximum antimuscarinic medication. Following open bladder biopsy, urothelial and smooth muscle cells were grown ex vivo and seeded onto a biodegradable scaffold to form a regenerative augment as the foundation for bladder tissue regeneration. Bladder neck sling was the only concomitant surgical procedure permitted. Bladders were cycled postoperatively to promote regeneration. Primary and secondary outcomes at 12 months included change in bladder compliance, bladder capacity and safety. Long-term assessment was done with similar outcomes at 36 months. Compliance improved in 4 patients at 12 months and in 5 patients at 36 months, although the difference was not clinically or statistically significant. There was no clinical or statistical improvement in bladder capacity at 12 or 36 months in any patient. Adverse events occurred in all patients, and most were easily treated. Two patients had low cell growth following bladder biopsy, of whom 1 withdrew from the study and 1 underwent a second biopsy. Serious adverse events of bowel obstruction and/or bladder rupture occurred in 4 patients."

According to the news reporters, the research concluded: "Our autologous cell seeded biodegradable scaffold did not improve bladder compliance or capacity, and our serious adverse events surpassed an acceptable safety standard."

For more information on this research see: Autologous Cell Seeded Biodegradable Scaffold for Augmentation Cystoplasty: Phase II Study in Children and Adolescents with Spina Bifida. Journal of Urology, 2014;191(5):1389-1394. Journal of Urology can be contacted at: Elsevier Science Inc, 360 Park Ave South, New York, NY 10010-1710, USA. (Elsevier - www.elsevier.com; Journal of Urology - www.elsevier.com/wps/product/cws_home/706695)

Our news correspondents report that additional information may be obtained by contacting D.B. Joseph, Wake Forest Baptist Med Center, Winston Salem, NC, United States. Additional authors for this research include J.G. Borer, R.E. De Filippo, S.J. Hodges and G.A. McLorie (see also Clinical Research).

Keywords for this news article include: Tissue Engineering, Biomedical Engineering, Biomedicine, Biopsy, Surgery, Spina Bifida, Winston Salem, United States, North Carolina, Bioengineering, Clinical Research, Spinal Dysraphism, North and Central America, Clinical Trials and Studies, Operative Surgical Procedures

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC


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Source: Biotech Week


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