Study on the Safety and Effectiveness of Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells for Treating Fecal Incontinence in Patients

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What is this study about?

This clinical trial is focused on studying a condition known as fecal incontinence, which is the inability to control bowel movements, leading to unexpected stool leakage. The study is testing a new treatment using allogeneic adipose-derived adult mesenchymal stem cells, which are special cells taken from fat tissue and expanded in a lab. These cells are then prepared in a gel made from hyaluronic acid, a substance that helps with tissue repair, and are injected directly into the affected area.

The purpose of the study is to evaluate the safety and effectiveness of this treatment. Participants will receive one of two different doses of the stem cells, or a placebo, to determine which dose works best. The study will monitor participants over a period of time to see how well the treatment improves their condition. This includes checking for any side effects and measuring changes in the severity of their incontinence using tests like the Jorge-Wexner test, which scores the degree of incontinence from 0 (no incontinence) to 20 (severe incontinence).

Throughout the study, participants will also keep a diary to record episodes of incontinence and complete a quality of life survey. Additional tests, such as anal manometry, which measures the pressure in the anal canal, will be conducted to assess any changes in the function of the anal muscles. The study aims to provide valuable information on whether this new cell-based treatment can offer a better quality of life for those suffering from fecal incontinence.

1 initial assessment

The initial assessment involves a comprehensive evaluation to confirm eligibility for the study. This includes reviewing medical history and conducting necessary tests to ensure the presence of a single internal and/or external sphincter defect, not exceeding 140 degrees.

The severity of fecal incontinence is assessed using the Wexner Test, requiring a score of 12 or more, or at least 6 episodes of fecal incontinence over a 21-day period.

2 informed consent

Written informed consent is obtained, ensuring understanding of the study’s purpose, procedures, and potential risks and benefits.

Commitment to use effective contraception throughout the study is required for both men and women.

3 treatment administration

The treatment involves the intralesional administration of allogeneic adipose-derived adult mesenchymal stem cells (AMSCs) conditioned in a hyaluronic acid matrix.

Two doses are used: ALOFEC-60 and ALOFEC-120, both administered as a suspension for injection via infusion.

4 follow-up assessments

Regular follow-up assessments are conducted to monitor safety and efficacy. This includes collecting data on any adverse events and changes in the severity of incontinence.

The Jorge-Wexner test is used to evaluate changes in incontinence severity, alongside a defecation diary to track episodes of fecal incontinence.

5 quality of life evaluation

The fecal incontinence quality of life scale is used to assess the impact of treatment on lifestyle, behavior, self-perception, and embarrassment.

Responses are scored from 1 to 5, with 1 indicating the worst quality of life status.

6 anal manometry

Anal manometry is performed to measure the anal pressure profile, including maximum basal pressure and maximum voluntary contraction pressure.

This helps determine the impact of treatment on sphincter and rectal sensitivity.

7 imaging assessments

3D endorectal ultrasound and proctoscopy are conducted to monitor the condition of the rectal wall, anal sphincters, and surrounding organs.

These imaging techniques help track the progress and effectiveness of the treatment.

8 final evaluation

The final evaluation includes a comprehensive review of all collected data to assess the overall safety and efficacy of the treatment.

The study aims to determine the best regenerative treatment dose for patients with fecal incontinence.

Who Can Join the Study?

Age between 18 and 80 years old, including both men and women.
Have a single defect in the internal and/or external sphincter, which is a muscle that helps control bowel movements. The defect should not be more than 140 degrees in size. This can include:
- Patients with a single external sphincter defect of 140 degrees or less, with or without an internal defect.
- Patients with no external sphincter defect but a single internal sphincter defect of 140 degrees or less.
Have a severity score of 12 or more on the Wexner Test, which measures the severity of fecal incontinence, or experience at least 6 episodes of fecal incontinence over a period of at least 21 days, as recorded in a Patient Diary.
Have experienced fecal incontinence for at least 1 year before joining the study.
Provide written informed consent, which means agreeing to participate in the study after understanding all the details.
Agree to use an effective method of birth control during the entire study period. For women, this can include oral contraceptives (pills), injections, implants, patches, an intrauterine device (IUD), or surgical sterilization. For men, this includes using a condom with a spermicidal cream.

Who Cannot Join the Study?

Patients who are not experiencing fecal incontinence cannot participate. Fecal incontinence is when a person has trouble controlling their bowel movements.
Patients who are younger than 18 years old or older than 75 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have any other medical condition that might interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Universitario Torrecardenas	Almeria	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.06.2022

Trial locations

Investigated drugs:

Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells Expanded

Adipose Tissue Allogeneic Adult Mesenchymal Stem Cells (AdMSCs) are special cells taken from fat tissue. In this trial, they are used to help repair and regenerate damaged tissues in patients with fecal incontinence. These cells are prepared in a special way, using a gel made from hyaluronic acid, which helps them work better when injected directly into the affected area. The goal is to see if these cells can improve the condition and determine the best amount to use for treatment.

Fecal incontinence – Fecal incontinence is the inability to control bowel movements, leading to unexpected leakage of stool. It can range from occasional leakage of stool while passing gas to a complete loss of bowel control. The condition may result from weakened or damaged muscles and nerves in the rectum and anus, often due to childbirth, surgery, or aging. It can also be associated with chronic conditions like diabetes or multiple sclerosis. The severity of fecal incontinence can vary, affecting daily activities and quality of life. It is often assessed using scales that measure the frequency and severity of incontinence episodes.

Trial ID:

2024-515766-13-00

Protocol code:

ALOFEC-2019

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells for Treating Fecal Incontinence in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?