EUCTR2007-006433-13-GB进行中（未招募）不适用
An open-label, multicentre study of augmentation cystoplasty using an autologous Neo-Bladder construct in subjects with spina bifida.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Tengion Inc.
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects between the ages of 3 and 21 years of age with myelodysplasia (spina bifida)
- •2. Willing and able to give signed informed consent, or have a legally authorized representative who is willing and able to give consent. Informed assent will be required for children < 18 years of age as appropriate or warranted.
- •3. Ability of subject and/or care provider to be successfully trained in clean intermittent catheterization and bladder cycling
- •4. Uilization of maximally-tolerated dose and regimen of medical therapy (e.g. anticholinergics) or failure to tolerate /contraindication to such agents
- •5. Medical need for bladder augmentation, as defined by the presence of:
- •a. Decreased and inadequate bladder compliance with a bladder pressure =40 cmH20 at or below estimated bladder capacity for age, OR
- •b. New-onset of upper urinary tract changes (hydronephrosis, vesicoureteral reflux) in the last 12 months
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Female subjects who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of child bearing potential and not using a highly effective method of birth control (including sexual abstinence). A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomised partner. Subjects must be willing to continue to use one of these methods throughout the duration of the study.
- •2. Recent (< 12 months) urological or intraperitoneal surgery or device implantation; recent (<6 month neurological surgery-brain or spine)
- •3. Any prior bladder augmentation procedure
- •4. Requirement of concomitant urological surgical procedures in addition to augmentation (e.g., ureteral reimplantation). Minor surgical correction for bladder neck incompetence (i.e., fascial sling) is permitted.
- •5. Known or suspected limitation to obtaining omentum for implantation procedure (e.g., extensive intraperitoneal adhesions)
- •6. Any contraindication to general anaesthesia
- •7. Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin
- •8. Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids [=0.25 mg/kg prednisone or equivalent per day] are permitted). Brief pulsed corticosteroids for intermittent symptoms (e.g., asthma) are permitted.
- •9. Known history of hypersensitivity to aminoglycosides or fluoroquinolones.
- •10. Use of any investigational product within 3 months
- •11. Prior participation in the study
- •12. Unwillingness, inability, or unlikely compliance with study related procedures
- •13. Any circumstance in which the investigator deems participation in the study is not in the subject’s best interest
- •14. Subjects with an ALT or AST value >3 times the upper limit of normal
- •15. Subjects with an albumin value <3.0 g/dL
- •16. Subjects with a history of an anaphylactic or a severe systemic reaction to the biodegradable polymers glycolic acid (PGA) and lactic-co-glycolic acid (PLGA)
- •17. Subjects with acute or chronic abdominal skin infections and/or acute or chronic inflammatory bowel disease
- •18. Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders, or bleeding disorders
- •19. Subjects who have received Botulinum Toxin A injections into the bladder within the previous 12 months.
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