Autologous Cell Seeded Biodegradable Scaffold for Augmentation Cystoplasty: Phase II Study in Children and Adolescents with Spina Bifida
Autologous Cell Seeded Biodegradable Scaffold for Augmentation Cystoplasty: Phase II Study in Children and Adolescents with Spina Bifida
复制标题
DOI：
10.1016/j.juro.2013.10.103
复制
发表时间：
2014-05-01
影响因子：
6.6
通讯作者：
McLorie, Gordon A.
中科院分区：
文献类型：
--
作者：
Joseph, David B.;Borer, Joseph G.;McLorie, Gordon A.
目的：在患有医学难治性神经源性膀胱的儿童/青少年中使用胃肠道段进行膀胱扩大术与严重并发症相关。我们评估了一种自体细胞接种的生物可降解支架（Tengion（R））膀胱扩大术作为替代传统的enterocystoplasty在this population.Materials和Methods：一项II期前瞻性研究进行神经性膀胱儿童由于脊柱裂需要enterocystoplasty逼尿肌压力40厘米水柱或更大，尽管最大的抗毒蕈碱药物。开放膀胱活检后，离体培养尿路上皮细胞和平滑肌细胞，并将其接种到可生物降解的支架上，以形成再生增强物作为膀胱组织再生的基础。膀胱颈悬吊术是唯一允许的伴随外科手术。术后循环膀胱以促进再生。12个月时的主要和次要结局包括膀胱顺应性、膀胱容量和安全性的变化。在36 months.Results：在12个月和5例患者在36个月的依从性改善4例患者进行了类似的结果进行了长期评估，虽然差异没有临床或统计学意义。在12或36个月时，任何患者的膀胱容量均无临床或统计学改善。所有患者均发生不良事件，大多数易于治疗。2例患者在膀胱活检后细胞生长较低，其中1例退出研究，1例接受第二次活检。肠梗阻和/或膀胱破裂的严重不良事件发生在4 patients.Conclusions：我们的自体细胞接种的生物可降解支架没有改善膀胱的顺应性或能力，我们的严重不良事件超过了可接受的安全标准。
Purpose: 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 (R)) for bladder augmentation as an alternative to traditional enterocystoplasty in this population.Materials and Methods: 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.Results: 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.Conclusions: Our autologous cell seeded biodegradable scaffold did not improve bladder compliance or capacity, and our serious adverse events surpassed an acceptable safety standard.