JPRN-UMIN000029841已完成未知
Evaluation of amnion-derived mesenchymal stem cells for treatment-resistant moderate Crohn's disesase - Evaluation of amnion-derived mesenchymal stem cells for treatment-resistant moderate Crohn's disesase
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 12
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
- 20years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Patients with fistula with uncontrollable abscess. (2) Patients with a history of total or subtotal colectomy. (3) Patients with a history of small intestinal resection or short bowel syndrome. (4) Patients with stoma, internal fistula or severe intestinal stricture. (5) Patients who underwent surgery within 4 weeks before informed consent. (6) Patients with a history of cancer in 5 years. (7) Patients who received any medicine or treatment not allowed certain period before registration, and other medicine or treatment for clinical trials, and patients who received any medicine or treatment not allowed to start, stop or change the dose. (8) Patients with uncontorollable systemic disease. (9) Laboratory tests within these ranges 1) Hemoglobin <8.0 g/dL 2) White blood cell count <3,000/microliter 3) Lymphocyte count <500 microliter 4) AST >3x upper limit 5) ALT >3x upper limit 6) Total bilirubin >2.0 mg/dL 7) Serum creatinine >2x upper limit (10) Patients who can not keep SpO2 of >94% (11) Patients positive for HIV-Ab, HTLV-1-Ab, HBs Ag, HCV-Ab. (12) Patients with uncontrollable severe infectious disease. (13) Patients with severe hypersensitivity to bovine-derived constituents, human serum albumin and gentamicin. (14) Patients with cancer, dysplasia or adenomatous polyp which needs to be treated in the colorectum. (15) Patients with a history of hypersensitivity to iodine or iodine-containing contrast agent. (16) Patients who had underwent any other treatment with cell therapy product. (17) Patients with a history of any severe neurological disorder. (18) Patients in pregnancy or breast-feeding, patients who want to be pregnant, patients who can not prevent conception. (19) Patients considered as ineligible to the study.
研究者
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