EUCTR2021-006068-26-ES进行中（未招募）1 期
CLINICAL TRIAL PHASE IIa TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TREATMENT WITH FAT-DERIVED MESENCHYMAL ALLOGENIC MESENCHYMAL TRONCAL CELLS IN PATIENTS WITH SINGLE INFLAMMATORY STENOSIS IN THE CONTEXT OF CROHN'S DISEASE.
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE0 个研究点目标入组 20 人开始时间: 2022年3月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients who agree to participate and agree to give their written consent. 2.
- •2.Patients over 18 years of age and under 75 years of age.
- •3.With Crohn's disease diagnosed at least 6 months earlier who meet clinical, endoscopic, histological and/or radiological criteria.
- •4.Presence of a single inflammatory stenotic lesion in the small bowel or ileocolic area with a maximum length of 5 cm, demonstrated by enteroresonance, producing episodes of intestinal occlusion/subocclusion. Other inflammatory lesions are acceptable, but only one should be identified as the obvious cause of the occlusion/subocclusion.
- •5.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
- •6.Women of childbearing age must have a negative pregnancy test at screening and agree to use effective contraceptive measures for the duration of study participation*.
- •Are the trial subjects under 18? no
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. 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 (without the need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
- •2. Severe intestinal obstruction that requires urgent surgery
- •3. Active outbreak of Crohn's disease 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.
- •4. History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin may be included
- •5. History in the last 6 months of severe, progressive or uncontrolled hepatic, hematological, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease.
- •6. Patients with primary sclerosing cholangitis.
- •7. Patients with known congenital or acquired immunodeficiency, including HIV.
- •8. Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium.
- •9. Contraindication to perform MRI (pacemaker, hip replacement or severe claustrophobia) or receive contrast with gadolinium.
- •10. Patients unwilling or unable to comply with study procedures.
- •11. Patients who are receiving, or have received any investigational medication in the 3 months prior to the screening period.
- •12. Major surgery or severe trauma in the previous 6 months.
- •13. Pregnant or lactating women.
- •14. Patients who have contraindications for general anesthesia, locoregional (depending on the type of anesthesia required) or laparoscopy1. 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 (without the need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
- •2. Severe intestinal obstruction that requires urgent surgery
- •3. Active outbreak of Crohn's disease 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.
- •4. History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin may be included
- •5. History in the last 6 months of severe, progressive or uncontrolled hepatic, hematological, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease.
- •6. Patients with primary sclerosing cholangitis.
- •7. Patients with known congenital or acquired immunodeficiency, including HIV.
- •8. Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium.
- •9. Contraindication to perform MRI (pacemaker, hip replacement or severe claustrophobia) or receive contrast with gadolinium.
- •10. Patients unwilling or unable to comply with study procedures.
- •11. Patients who are receiving, or have received any investigational medication in the 3 months prior to the screening period.
- •12. Major surgery or severe trauma in the previous 6 months.
- •13. Pregnant or lactating women.
- •14. Patients who have contr
研究者
相似试验
进行中（未招募）
不适用
A PHASE II CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF AMPHOTERICIN B LIPID COMPLEX (ABELCET®) FOR THE PROPHYLAXIS OF INVASIVE PULMONARY ASPERGILLOSIS DURING PROLONGED NEUTROPENIA IN PAEDIATRIC PATIENTS WITH ACUTE LEUKAEMIAEUCTR2011-000499-32-ESFUNDACIÓ SANT JOAN DE DE
招募中
2 期
Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery.2024-515235-29-00Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud15
进行中（未招募）
不适用
A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITISEUCTR2010-023798-20-ESFundacion para la Investigacion Biomedica Hospital Universitario La Paz
招募中
1 期
PHASE IB/II CLINICAL TRIAL EVALUATING THE SAFETY AND EFFICACY OF CHEMOIMMUNOTHERAPY PLUS SHORT COURSE OF MEK INHIBITOR IN FIRST LINE OF TREATMENT OF METASTATIC NON SQUAMOUS NON SMALL CELL LUNG ADENOCARCINOMA WITH PDL1 <50%Patients with localy advanced or metastatic non squamous non small cell lung cancer with PDL1?50%.MedDRA version: 20.0Level: LLTClassification code: 10079440Term: Non-squamous non-small cell lung cancer Class: 10029104CTIS2023-508477-87-00Centr Georges Francois Leclerc102
进行中（未招募）
1 期
A phase IIa clinical trial to evaluate the safety and efficacy of osirmertinib in first-line patients withadvanced or metastatic non-small cell lung cancer (AZENT study)EUCTR2015-004828-66-ESMedica Scientia Innovation Research (MedSIR ARO)73