CTIS2023-507108-30-00招募中1 期
A phase II, national, multicenter, uncontrolled and open trial to evaluate the feasibility and safety of lamparoscopic administration of allogenic mesenchymals stem cell (adMSC) extracted by lipoaspirate from healthy patients, for the treatment of patients with inflammatory bowel strictures associated with Crohn's disease. SM - FJD-MEIC-21-01
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz0 个研究点目标入组 20 人开始时间: 2023年7月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients who agree to participate and agree to give their written consent, Patients over 18 years of age and under 75 years of age, With Crohn's disease diagnosed at least 6 months earlier who meet clinical, endoscopic, histological and/or radiological criteria, Presence of a single inflammatory stenotic lesion in the small bowel or ileocolic area or anastomotic area of the small bowel or ileocolic area, either recent, or in the context of inflammatory recurrence, with a maximum length of 10 cm, demonstrated by enteroresonance, resulting in episodes of intestinal occlusion/subocclusion. Other inflammatory lesions are acceptable, but only one lesions are acceptable, but only one should be identified as the obvious cause of the occlusion/subocclusion. occlusion/subocclusion, Patients treated with at least one biologic drug and with inadequate response to maintenance doses and prior to intensification (either dose, interval or change/addition of another drug): a. anti-TNF (for at least 14 weeks, which includes induction and/or maintenance doses): Infliximab, Adalimumab, Certolizumab. b.Anti-integrin(at least for 14 weeks, which includes induction and/or maintenance doses): Vedolizumab c.Anti-IL-12/23(at least for 16 weeks, which includes induction and/or maintenance doses): Ustekinumab, Women of childbearing age must have a negative pregnancy test at screening and agree to use effective contraceptive measures for the duration of their participation in the study
排除标准
- •Intra-abdominal abscesses larger than 3 cm not drained (surgically, by interventional radiology) or not treated with antibiotics. Patients may be included once the abscess has been drained (no need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests., Patients unwilling or unable to comply with the study procedures., Patients who are receiving, or have received, any investigational drug in the 3 months prior to the screening period., Major surgery or severe trauma in the previous 6 months, Pregnant or breastfeeding women., Patients with contraindications for general anesthesia, locoregional anesthesia (depending on the type of anesthesia required) or laparoscopic surgery., Severe intestinal obstruction requiring urgent surgery., Active Crohn's disease flare-up requiring medical treatment, defined as abdominal pain, fever, bloody diarrhea and CRP greater than 10. The patient may be included once the condition has resolved, when the patient is on maintenance medication., History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin can be included., History in the last 6 months of severe, progressive or uncontrolled hepatic, hematologic, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurologic or psychiatric disease., Patients with primary sclerosing cholangitis., Patients with known congenital or acquired immune deficiency, including HIV., Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium., Contraindication to perform MRI (pacemaker, hip prosthesis or severe claustrophobia) or receive contrast with gadolinium.
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