ACTRN12624000537550尚未招募Unknown
A human pilot study evaluating the safety of locally administered human amnion epithelial cells for the treatment of refractory ulcerative proctitis in adults
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1.Adult participant
- •2.Ulcerative proctitis defined by less than 15 cm length of active inflammation from anus
- •3.At least 6 months disease duration
- •4.Refractory to at least one of the following treatments: topical aminosalicylate or prednisolone or budesonide. Definition of lack of response will assessed as per Modified Mayo Score of 5 or more, endoscopic subscore of 2 or more.
排除标准
- •1.Acute severe ulcerative colitis
- •2.Rectal or anal stenosis
- •3.Diverting stomas
- •4.Perianal or rectovaginal fistula
- •5.Active infection
- •6.Any previous colonic dysplasia or malignancy
- •7.Inability to tolerate or comply with trial requirements eg. high anaesthetic risk unsuitable for endoscopy
- •8.Current pregnancy/breast feeding
研究者
相似试验
已完成
不适用
Human study evaluating effectiveness and safety of Curezyme-LAC on body fat level and related metabolism in obese adultsEndocrine, nutritional and metabolic diseasesKCT0005095Amicogen100
已完成
1 期
A first-in-human study to evaluate the safety tolerability and performance of A/California/7/2009 (H1N1)- like vaccine coated Nanopatches in comparison to placebo coated Nanopatches and intramuscular injection of A/California/7/2009 (H1N1)-like vaccine.. Nanopatches will be delivered to skin using the Vaxxas Clinical Applicator Disposable Device (CAPD).Prophylaxis for H1N1 infectionInfection - Other infectious diseasesACTRN12616000880448Vaxxas Pty Ltd60
进行中（未招募）
不适用
A pilot study to assess the efficacy and safety of LCQ908 alone and in combination with fenofibrate or Lovaza® in patients with severe hypertriglyceridemiaon Familial Chylomicronemia Syndrome (Non-FCS)MedDRA version: 14.1Level: LLTClassification code 10020870Term: HypertriglyceridemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersNon Familial Chylomicronemia Syndrome (Non-FCS)EUCTR2012-000872-40-CZovartis Pharma Services AG60
已完成
3 期
A pilot study to assess the efficacy and safety of Heliox inhalation therapy for resuscitation to preterm infants.preterm infantsJPRN-UMIN000015061agano Children's Hospital10
进行中（未招募）
1 期
Pilot study to evaluate the efficacy and safety of mefloquine as prophylaxis in people exposed to the disease caused by the new SARS-CoV-2 coronavirus (COVID-19)COVID-19 infection is being spread around the world with more than 400.000 cases. The spred of the disease is being a world health problem.EUCTR2020-001194-69-ESFélix Gutiérrez Rodero200