EUCTR2010-021463-32-GB进行中（未招募）1 期
Skeletal muscle-derived cell implantation for the treatment of fecal incontinence: a multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-finding clinical study - STEFFI
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
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 > or = 18 years of age,
- •2. Patients suffering from FI for more than 6 months, which is confirmed at screening by relevant medical history and anorectal examination,
- •3. Patients with Wexner score >9 and with at least 3 episodes of FI per week as measured in the bowel diary prior to Visit -1,
- •4. Patients with no indications against a surgery under anesthesia,
- •5. Patients willing and able to comply with the study procedures,
- •6. Patients who are mentally competent and able to understand all study requirements,
- •7. Patients must agree to read and sign the Informed Consent (IC) form prior to any study-related procedures,
- •8. Female patients of childbearing potential willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- •Interim Inclusion Criterion:
- •Patients with a minimum of 3 non-gaseous incontinence episodes per week measured using the diary during the 2 weeks prior to visit -1 (day -70) (diary distributed at screening visit)
- •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 227
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.1.Patients with pathological findings considered clinically relevant by the Investigator (excluding sphincter damage) based on rectoscopy, anorectal manometry and ultrasound at the screening visit (e.g. grade I haemorrhoids would be considered acceptable),,
- •2. Patients who have undergone any anorectal surgery within the last 6 months prior to screening visit,
- •3. Patients with more than one overlap repair surgery,
- •4. Patients with more than 2 anorectal surgical procedures (in total) e.g.
- •- primary repair after delivery and one overlap repair later-on,
- •- in- and explantation of a permanent neurostimulation system,
- •5. Patients with overlap repair and associated early atrophy of external anal sphincter,
- •6. Patients with a history of artificial anal sphincter surgery,
- •7. Patients with trans- or perianal injection of any bulking products,
- •8. Patients with a malignant disease not in remission for 5 years or more,
- •9. Patients who had undergone radiation therapy,
- •10. Patients who had undergone chemotherapy within last 5 years prior to study enrolment,
- •11. Patients with chemotherapy related neuropathy of the bowel and pelvis,
- •12. Patients with compromised immune system and/or rheumatic disease,
- •13. Patients under immunosuppressive therapy,
- •14. Patients with a diagnosis of chronic inflammatory bowel disease,
- •15. Patients with current and/or recurrent anal fistula disease,
- •16. Patients with chronic diarrhea,
- •17. Patients suffering from a disease which has not been
- •resolved within a timeframe prior to screening as follows:
- •fever and/or diarrhea of unknown reasons (4 weeks), HAV
- •(4 months), toxoplasmosis (6 months), osteomyelitis, Qfever, rheumatic fever, tuberculosis, or Salmonella infections (2 years), and malaria (4 years).
- •18. Patients who, according to the clinical judgment of the investigator, are not suitable for inclusion due to acute anal sphincter injury including obstetric and other trauma, acute disc prolapse, or neurological diseases (spinal cord injury, multiple sclerosis, Parkinson’s disease, stroke, etc.),
- •19. Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain,
- •20. Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis, HTLV (tested upon risk assessment by investigator),
- •21. Patients diagnosed with any kind of skeletal muscle disease and/or neuronal disorders,
- •22. 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]),
- •23. Patients with clinically relevant abnormal laboratory values, any persistent chronic bacterial infections as well as local infections as indicated by a high level of the C-reactive protein (CRP) of >35 mg/l and confirmed by bacteriological analysis, or with any bleeding disorder,
- •24. Patients who, according to the clinical judgment of the investigator, are not suitable for this study,
- •25. Patients who are currently participating or have participated in another clinical trial (testing a medical device or drug) within 30 days prior to the study begin or have previously participated in the current clinical study,
- •26. Patients who are pregnant, lactating, or intending pregnancy in the near future, (before Visit 4), and those of childbearing potential who are not willing to use acceptable methods of contraception up to Visit 4 (birth c
研究者
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