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New treatment option for Fecal Incontinence
Official title Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
ClinicalTrials.gov ID: NCT04976153
What this study is testing
What is aSMDC?
aSMDC is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for fecal incontinence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Urge fecal incontinence episodes that occur more than twice a week
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Hall in Tirol, Austria
- Sevlievo, Bulgaria
- Brno, Brno, Czechia
- Prague, Czechia
- Paris, France, France
- Rennes, France
- Rouen, France
- Cologne, North Rhine-Westphalia, Germany
- Mannheim, Germany
- San Donato Milanese, Milano, Italy
- Milan, Italy
- Sapporo, Hokkaido, Japan
- Chiba, Japan
- Fukuoka, Japan
- Hiroshima, Japan
- Hyōgo, Japan
- Kanagawa, Japan
- Kumamoto, Japan
- Kyoto, Japan
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Hall in Tirol, Austria; Sevlievo, Bulgaria; Brno, Brno, Czechia; Prague, Czechia; Paris, France, France and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.