Autologous Muscle Fiber Fragment Injections

Fecal Incontinence Clinical Trial

Official title:

Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396456
• Other study ID #: IRB00085606
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Mary-Clare Day, RN, BSN
• Phone: 336.713.1343
• Email: mday[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)

Description:

The Study hypothesizes that efficient re-assembly of injected fragments within host muscle tissue along the fiber direction of native muscle will be induced. It is anticipated that these fiber fragments would integrate into the host vascular and neural network.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

• participants must experience 4 or more Fecal Incontinence (FI) episodes per 2 week period

• participants must score >10 on Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS)

• participants must have had symptoms for at least 12 months

• participants who have failed standard medical and surgical treatments for FI

• participant will undergo anorectal manometry (ARM) testing

• participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees

• women of childbearing potential must use acceptable contraceptives during this study

Exclusion Criteria:

• participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage

• participants with pre-existing ano-rectal pain of any cause

• participants with incontinence of flatus only

• chronic watery diarrhea which is the primary cause for fecal incontinence

• acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae)

• presence of anorectal tumors

• active proctitis or inflammatory bowel disease

• previous injection of internal anal sphincter (IAS) with bulking agents

• participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment

• participants with a defined bleeding disorder diagnosed and treated by a hematologist

• other exclusions include history of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months, or treatments using injection or infrared coagulation for treatment of hemorrhoids

• participants with neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction

• women who are pregnant, breastfeeding, or have had a child within the last year

• participants with a history of unstable cardiac function (New York Heart Association Functional Classification III or IV) or unstable pulmonary function requiring home oxygen, or abnormal kidney function (Cr >1.5 mg/dl or on dialysis) or uncontrolled diabetes (Hemoglobin A1C > 8 mg/dl)

• participants with anemia (hemoglobin <10g, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 times normal) or increased bilirubin >1.5mg/dl

• participants with Hepatitis B or C, or human immunodeficiency virus (HIV)-1 or 2

• rectal prolapse

• vaginal prolapse beyond the hymen

• unable to understand informed consent information even with provision of a medical translator

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Procedure:
• Muscle Fiber Fragment (MFF) Injections
The participant will be treated with an injection of muscle fiber fragments into the external anal sphincter at 3, 6, 9 and 12 o'clock using a 21-gauge needle to a depth of 1-2 cm from the external skin using equal amounts in each quadrant.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anorectal endoscopic ultrasound (EUS)	This standard procedure is performed with a rotating rectal probe without sedation or deep sedation	Months 3 and 12
Primary	Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)	fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence	Month 3
Primary	Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)	fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence	Month 6
Primary	Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)	fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence	Month 12
Secondary	Change in Fecal Incontinence Quality of Life (FI-QOL) scores	The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items).	baseline, Months 3 and 12
Secondary	Anorectal Manometry (ARM) Pressure scores	Low resting pressure is defined as <50 mmHg during the anorectal motility exam performed with high-resolution catheter (Given, Atlanta, GA). Normal resting pressures range from 50 to 100 mmHg.; A flexible catheter with solid-state pressure transducers is placed in the anal canal and rectum to obtain standard pressure measurements	baseline, Months 3 and 12
Secondary	Internal Anal sphincter (IAS) Pressure scores	Typical resting pressure in a healthy volunteer is 40 to 60 mmHg	baseline, Months 3 and 12
Secondary	Rectal Anal Inhibitory Reflex (RAIR) Pressure scores	Low resting pressure is defined as <50 mmHg during the anorectal motility exam performed with high-resolution catheter (Given, Atlanta, GA). Normal resting pressures range from 50 to 100 mmHg.; A flexible catheter with solid-state pressure transducers is placed in the anal canal and rectum to obtain Rectal Anal Inhibitory Reflex (RAIR)	baseline, Months 3 and 12
Secondary	Fecal Incontinence Severity Index (FISI) scores	Participants who score closer to 61 are likely to have their quality of life severely impacted by the fecal incontinence they suffer from.	baseline, Months 3 and 12