Using muscle cells to treat fecal incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of autologous skeletal muscle-derived cells for patients suffering from urge fecal incontinence due to dysfunction of the external anal sphincter. Participants will receive either the muscle cell treatment or a placebo, and their outcomes will be assessed over time. The study focuses on individuals who have not found relief from conservative treatments and have specific measurable impairments in anal sphincter function. The goal is to determine if this innovative approach can significantly improve symptoms and quality of life for affected patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must be at least 18 years old
* Patients who are mentally competent and able to understand all study requirements
* Female patients of childbearing potential willing to use appropriate methods of contraception
* Patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months and did not improve sufficiently by conservative treatment performed for at least 3 months
* Urge fecal incontinence episodes that occur more than twice a week
* Maximal incremental voluntary squeeze pressure (increase to resting pressure) on anal manometry is 100mmHg or less in women and 150mmHg or less in men
* 9\. Ultrasound of the anal canal showing intact external anal sphincter or a maximal overall extent of external anal sphincter injury and tear of 180 degrees

Exclusion Criteria:

* Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction.
* Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound
* Patients who underwent any anorectal surgery within 6 months before screening visit
* Patients who underwent a total of two or more external anal sphincter-related surgeries
* Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fissures
* Patients with poorly controlled chronic constipation including obstructed defecation syndrome
* Patients with indications against a surgery under anesthesia
* Patients with a malignant disease not in remission for 5 years or more
* Patients who have undergone radiation therapy of the bowel and pelvis
* Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis
* Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy
* Patients with a diagnosis of chronic inflammatory bowel disease (e.g Crohn's disease, Colitis Ulcerosa)
* 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)
* Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (tested upon risk assessment by investigator)
* Patients diagnosed with any kind of skeletal muscle disease and/or neuronal disorders
* Patients with severe myocardial disorders, irregular pulse or a pacemaker
* Patients with implantations of metal components in the electrical stimulation treatment area
* Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain
* Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment

Where it's running

• Medical University Graz
  Graz, Austria Recruiting
• Landeskrankenhaus Hall in Tirol
  Hall in Tirol, Austria Recruiting
• Medical Center Unimed EOOD
  Sevlievo, Bulgaria Recruiting
• Fakultni nem. u sv. Anny v Brne
  Brno, Brno, Czechia Recruiting
• The Institute for the Care of Mother and Child
  Prague, Czechia Recruiting
• Deaconess Hospital Group Croix Saint - Simon
  Paris, France, France Recruiting

Study contacts

• Study coordinator: Innovacell
• Email: office@innovacell.com
• Phone: +43512573680

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Active vs. Passive Anal Sphincter Training in Fecal Incontinence

  This home-based trial tests whether adding active sphincter contractions to electrical stimulation helps adults with fecal incontinence more than stimulation alone.

  Recruiting University Hospital, Martin · Martin · NCT07604415

• Beta-glucan cream added to standard skin care for IAD in hospitalized adults

  This study tests whether adding a 0.5% beta-glucan moisturizing cream to usual skin care helps adults with incontinence-associated dermatitis heal faster and feel better.

  Recruiting University of Alberta · Edmonton, Alberta · NCT07524439

• R20 Sacral Neuromodulation for Fecal Incontinence: Post‑Market Follow‑Up

  This registry test checks how well the Axonics R20 rechargeable device works for adults with fecal incontinence after it’s on the market.

  Recruiting at 4 sites Axonics, Inc. · New York, New York and 4 other locations · NCT07499258

• High-intensity electromagnetic stimulation for bowel control after J-pouch surgery

  Aims to see if the Emsella chair can help people with a J pouch who have fecal incontinence after ulcerative colitis surgery.

  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT07034443

• Intra-rectal Botulinum Toxin Injection for Children with Non-Retentive Fecal Incontinence

  This trial tests whether injecting botulinum toxin into the rectum can help children who have frequent non-retentive fecal incontinence that isn’t caused by constipation.

  Recruiting Early Phase 1 Shaare Zedek Medical Center · Jerusalem · NCT06785844

• Investigating the effects of sacral neuromodulation on fecal incontinence and the external anal sphincter

  This study is trying to see how a treatment called sacral neuromodulation can help people with fecal incontinence by looking at changes in the muscles around the anus.

  Recruiting Umeå University · Umeå, Västerbotten County · NCT06763861

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.