A Prospective Nonrandomized Study of Autologous Muscle Derived cell (AMDC) Transplantation for Treatment of Fecal Incontinence - Cook MyoSite AMDC Fecal Incontinence Clinical Study 09-025

Cook Myosite, Incorporated0 个研究点目标入组 48 人开始时间: 2014年3月3日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•- Patient has primary symptoms of fecal incontinence, as confirmed by patient medical
•history and physical examination, including visual inspection, digital rectal
•examination, anoscopy and/or sigmoidoscopy
•- Patient has a Wexner score of = 5 at baseline
•- Patient has failed conservative treatment (e.g. dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 1 month prior to enrollment
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Evidence of faecal impaction or overflow on digital rectal examination
•- Patient has undergone a gracilis sling repair, insertion of an artificial sphincter, or anorectal operation that has caused damage to sphincter that might confound the study results
•- Patient has Inflammatory Bowel Disease (Crohn’s disease, ulcerative colitis)
•- Patient has known significant pelvic floor abnormalities with high pressure instability,significant rectocele, or prolapse beyond the introitus
•- Patient is less than 18 years of age
•- Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study
•- Patient is morbidly obese (BMI = 35)
•- Patient has uncontrolled type I or type II diabetes
•- Patient is not suitable for muscle biopsy as determined by physician
•- Patient has positive diagnosis for Hepatitis B, Hepatitis C, Syphilis or HIV at screening
•- Patient has a compromised immune system due to disease state, chronic
•corticosteroid use or other immunosuppressive therapy
•- Patient is simultaneously participating in another investigational drug or device study or the patient has completed the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study
•- Patient is unable or unwilling to provide informed consent
•- Patient is unable or unwilling to commit to the follow-up procedures
•- Patient is febrile (defined as temperature = 38.5 °C)at Time of Cell Delivery

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