EUCTR2021-005399-21-AT招募中1 期
Skeletal muscle-derived cell implantation for the treatment of fecal incontinence: a single arm, open label, interventional, follow-up study - STEFFI-F
Innovacell AG0 个研究点目标入组 10 人开始时间: 2021年11月19日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •1.Patients who participated in the phase IIb STEFFI study (IC-01-02-02-007) and were randomized to placebo
- •2.Patients must agree to read and sign the Informed Consent (IC) form prior to any study-related procedures
- •3.Patients willing and able to comply with the study procedures
- •4.Patients who are mentally competent and able to understand all study requirements
- •5.Female patients of childbearing potential willing to use appropriate methods of contraception. Women considered of childbearing potential shall only be included in the study after a confirmed menstrual period and a negative pregnancy test.
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients who, according to the clinical judgment of the investigator, are not suitable for this study
- •2.Patients deprived of their liberty by a judicial or administrative decision, patients admitted to a hospital, social institution or who are under a measure of legal protection, patients hospitalized without consent or who are in an emergency
- •3.Patients who are currently participating or have participated in another clinical study (test-ing a medical device or drug) within 30 days prior to screening Visit 1
- •4.Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives, etc.)
- •5.Female patients who are pregnant, lactating, or intending pregnancy in the near future and female patients of childbearing potential who are not willing to use appropriate methods of contraception up to Visit 5 or who have a positive pregnancy test (only to be performed in women of childbearing potential)
- •6.Patients who underwent any anorectal surgery within 6 months before screening visit
- •7.Patients with indications against a surgery under anesthesia
- •8.Patients with a malignant disease not in remission for 5 years or more
- •9.Patients who have undergone radiation therapy of the bowel and pelvis
- •10.Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis
- •11.Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy
- •12.Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and/or diarrhea of unknown reasons (4 weeks)
- •13.Patients with known hypersensitivity to any component of the product (autologous cells, Ringer’s lactate, human serum albumin, DMSO, bovine proteins, fibroblast growth factor [FGF]), gentamycin)
- •14.Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepa-titis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (tested upon risk assessment by investigator)
- •15.Patients diagnosed with any kind of skeletal muscle disease and/or neuronal disorders
- •16.Patients with severe myocardial disorders, irregular pulse or a pacemaker
- •17.Patients with implantations of metal components in the electrical stimulation treatment area
- •18.Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain
- •19.Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment
研究者
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