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Completed

NCT Number: NCT03466515

Stem Cells Treatment of Complex Crohn's Anal Fistula

A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease.

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Key information

Conditions

Anal Fistula Crohn Disease Digestive System Diseases Digestive System Fistula Fistula Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

Stem cells therapy in the management of soft tissue healing has been shown to be safe and feasible with encouraging short-term results both for crypto glandular and Crohns anal fistula. The long-term results are still insufficient but based on only a few studies conducted with small patient series and various techniques and type of stem cells. In the present study the patient's own adipose tissue derived regenerative cells (ADRCs) will be used. Traditionally the stem cells are injected into the fistula tract; however survival and retaining the stem cells in the fistula tract is problematic. Alternatively, one may apply stem cells enriched fatty tissue around and into the fistula tract. The aim of this project is to develop a method for treatment of patients with Crohns fistula. The results of conventional surgery are disappointing and followed by a high degree of recurrence and complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with Crohn's anal fistulas and> 18 yrs old.

Exclusion criteria

  • Signs of suppuration around the fistula
  • Active intestinal Crohn disease not in remission
  • Malignancy within 5 years
  • Previous radiotherapy of the abdomen and pelvis
  • BMI under 18.5
  • Coagulopathy
  • Fistula with side branches
  • Low anal fistula
  • Verified syphilis, HIV, or hepatitis on screening test.

Treatment and study plan

stem cells injection

Procedure

two surgical interventions as day-surgery, starting with liposuction from the abdomen (about 200-300 ml), and fistula tract debridement and closure of internal opening. The external opening is excised. About 30-40 ml fresh harvested patients own fatty tissue are then injected with large needle around the fistula from internal til external opening.The resting harvested fatty tissue will be sent to stem cells (Adipose Derived Regenrative Cells ADRCs) isolation, using Cytori Celusion system®. When the stem cells isolation is completed, 4ml concentrated stem cells ( contains around 20-40 millions cells ) will be injected around the prepared fistula tract, the same site where the fresh harvested fatty tissue injected before.

Other names: liposuction, fistula closure

Primary outcomes

  1. healing

    Time frame: 6 months

    closure of the fistula with no secretions

Secondary outcomes

  1. recurrence

    Time frame: 6 months

    recurrence of the fistula

  2. time to healing

    Time frame: 6 months

    time required to healing of the fistula

  3. major adverse effects

    Time frame: 6 months

    occurrence of infections, sepsis bleeding and allergy.

  4. radiological healing

    Time frame: at 6 months

    Changes on MRI scanning

  5. functional outcome

    Time frame: 6 months

    changes in Wexner incontinence score

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study

Acronym: fistula

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2018
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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