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Study on Treating Perianal Fistulas Using Adipose Derived Regenerative Cells, Metronidazole, and Cefuroxime for Patients with Complex Perianal Fistulas

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on treating a condition known as perianal fistula, which is a small tunnel that develops between the end of the bowel and the skin near the anus. The study aims to explore the effectiveness of using regenerative cell therapeutics to repair these fistulas. The treatment involves a combination of minimal surgical cleaning of the affected area and the use of special cells called Adipose Derived Regenerative Cells (ADRC) and Culture expanded Adipose Derived Regenerative Cells (ADRC001). These cells are derived from fat tissue and are believed to help in the healing process.

In addition to the regenerative cells, the study will also use medications such as Metronidazole and Cefuroxime, which are antibiotics that help fight infections. The purpose of the study is to evaluate how well this combination of treatments works in healing the fistulas and improving the quality of life for patients. The study will compare the use of ADRC and ADRC001 to see which is more effective and will also look at how these treatments affect the body's immune response.

Participants in the study will receive the treatment and be monitored over a period of time to assess the healing of the fistulas. The study will measure the healing rate at six and twelve months, as well as the impact on the patient's quality of life and anal continence. The study will also investigate the risk factors for the recurrence of the fistulas and use MRI scans to check for any remaining fistula or fluid collection. The goal is to find a more effective way to treat perianal fistulas and improve patient outcomes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination to ensure the presence of a complex crypto-glandular perianal fistula.
Step 2
Minimal surgical debridement
A minimal surgical procedure is performed to clean the affected area. This step is necessary to prepare for the application of regenerative cell therapy.
Step 3
Administration of regenerative cell therapy
Adipose Derived Regenerative Cells (ADRC) are administered as a suspension for injection. This therapy aims to promote healing of the fistula.
Step 4
Medication regimen
Following the procedure, Metronidazole Tablets 500 mg are taken orally to prevent infection. The dosage and duration are determined by the healthcare provider.
Additionally, Zinnat 500 mg film-coated tablets are prescribed to further support infection control.
Step 5
Follow-up assessments
Regular follow-up assessments are scheduled to monitor healing progress. These include clinical evaluations and imaging studies to assess the closure of the fistula and absence of discharge or swelling.
The primary endpoint is the healing rate observed at six and twelve months.
Step 6
Quality of life and functional outcome evaluation
Quality of life and anal continence are evaluated using the Short Form SF-36 Rand questionnaire and the Wexner Fecal Incontinence score.
Step 7
Final evaluation
A final evaluation is conducted to determine the overall success of the treatment, including any recurrence of the fistula and the effectiveness of the regenerative cell therapy.

Who can join the trial?

6 criteria

Must be an adult (18 years or older).
Have a complex perianal fistula, which is a type of abnormal connection near the anus. It should be either high transsphincteric or suprasphincteric, meaning it involves more than 30% of the muscle that controls the anus.
Must be referred to the surgical department at Odense University Hospital for treatment.
Must be able to communicate in the Danish language.
Must have an address in the region of southern Denmark during the study.
Both male and female participants are eligible.

Who cannot join the trial?

4 criteria

Patients with conditions other than **crypto-glandular perianal fistula** cannot participate. This is a specific type of condition affecting the area around the anus.
Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Participants who do not meet the gender criteria for the study are excluded. Both males and females are eligible, but specific criteria may apply.
Individuals considered part of a vulnerable population are not eligible. This means people who might need special protection or care are not included.

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Odense University Hospital
Odense, Denmark

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Investigated drugs

Regenerative Cellular Therapeutics
are used in this trial to help repair complex perianal fistulas. These therapeutics involve using special cells that can aid in healing and tissue regeneration. The goal is to promote the natural repair processes of the body to close and heal the fistulas effectively.
Minimal Surgical Debridement
is a procedure included in the trial to prepare the fistula area for treatment. This involves carefully cleaning and removing any unhealthy tissue around the fistula. This step is important to ensure that the regenerative cellular therapeutics can work effectively in a clean and healthy environment.

What is already known about the treatment

Regenerative Cell Therapeutics – This treatment is administered through a combination of minimal surgical debridement and the application of regenerative cells directly to the affected area. It is currently being studied in clinical trials for its effectiveness in treating complex crypto-glandular perianal fistulas. The main therapeutic indication is to promote healing in these difficult-to-treat fistulas. At the molecular level, the regenerative cells are believed to aid in tissue repair and regeneration by modulating the local immune response and promoting new tissue growth. This treatment falls under the pharmacological classification of regenerative medicine, which focuses on restoring function by replacing or regenerating human cells, tissues, or organs.

Investigated diseases

Crypto-glandular perianal fistula – This condition involves an abnormal connection between the anal canal and the skin near the anus, often resulting from an infection in the anal glands. It typically presents with symptoms such as pain, swelling, and discharge near the anus. The fistula forms when an abscess, or pocket of pus, drains but leaves a tunnel behind. Over time, the fistula may become more complex, with multiple openings or branches. The condition can cause discomfort and may lead to recurrent infections if not managed. It is often associated with inflammation and can affect daily activities due to its symptoms.