EUCTR2021-001376-42-CZ进行中（未招募）1 期
Skeletal muscle-derived cell implantation for the treatment of fecalincontinence: a phase III, randomized, controlled, double blind, two armedclinical study. - FI-3 Fidelia
Innovacell AG0 个研究点目标入组 290 人开始时间: 2021年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 290
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 of >=18 years of age
- •2. Patients willing and able to comply with the study procedures
- •3. Patients who are mentally competent and able to understand all study requirements
- •4. Patients must agree to read and sign the Informed Consent (IC) form prior to any study-related procedures
- •5. Female patients of childbearing potential willing to use appropriate methods of contracep-tion (see Section 8.4.6.3). Women considered of childbearing potential shall only be in-cluded in the study after a
- •confirmed menstrual period and a negative pregnancy test.
- •Inclusion criteria, part 2, related to fecal incontinence:
- •6. At Screening (V1), the patient has symptoms of urge fecal
- •incontinence with a disease duration of at least 6 months but equal or less than 10 years
- •7. Urge fecal incontinence episodes exceeding 'traces' (as defined by the patient's baseline diary) that occur more than twice a week
- •8. Incremental voluntary maximum squeeze pressure on anal
- •manometry is 100mmHg or less in women and 150mmHg or less in men
- •9. Ultrasound of the anal canal showing the overall extent of external
- •anal sphincter injury and tear of 180 degrees or less
- •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 145
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 145
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 in this study or have previously participated in this study
- •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 meth-ods (see section 8.4.6.3) of contraception up to Visit 8 or who have a positive pregnancy test (only to be performed in women of childbearing potential)
- •6. Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction. This evaluation is based on the current medical history, surgi-cal history, physical examination, anoscopy, anorectal manometry and anal canal ultra-sonography at the screening visit (V1)
- •As specific exclusion:
- •Patients with chronic diarrhea or liquid stool that my cause fecal
- •incontinence
- •Patients with rectal fecal impaction that may be the cause of overflow fecal in-continence
- •Patients who may have passive fecal incontinence due to rectal
- •hypersensitivity and lack of urge to defecate
- •Patients in whom the cause of fecal incontinence is considered to be or cannot be excluded to be neuropathy or myelopathy
- •Patients with Goligher class III internal hemorrhoids (patients with
- •Goligher class I and class II internal hemorrhoids are not excluded as
- •they are considered not clin-ically involved in fecal incontinence)
- •7. Patients with global fragmentation of the external anal sphincter as assessed by anal ca-nal ultrasound
- •8. Patients who underwent any anorectal surgery within 6 months before screening visit
- •9. Patients who underwent a total of two or more external anal
- •sphincter-related surgeries (only one repair after an obstetric injury
- •after vaginal birth is allowed)
- •10. Patients who currently have anal fistulas or fissures or have
- •recurrent anal fistulas or fis-sures
- •11. Patients with poorly controlled chronic constipation including
- •obstructed defecation syn-drome
- •12. Patients with indications against a surgery under anesthesia
- •13. Patients with a malignant disease not in remission for 5 years or
- •14. Patients who have undergone radiation therapy of the bowel and
- •15. Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis
- •16. Patients with compromised immune system and/or rheumatic
- •disease, and patients under immunosuppressive therapy
- •17. Patients with a diagnosis of chronic inflammatory bowel disease
- •18. 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)
- •19. 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)
- •20. Patients diagnosed with human immunodeficiency virus (HIV),
研究者
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