Stem Cells Treatment of Complex Crohn's Anal Fistula

NCT03466515 | Completed DMC

• 1 other identifier: S-20170140
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anal Fistula; Crohn Disease

Keywords

stem cells therapy

Outcome Measures

Primary Outcomes (1)

• healing

  closure of the fistula with no secretions

  6 months

Secondary Outcomes (5)

• recurrence

  6 months

• time to healing

  6 months

• major adverse effects

  6 months

• radiological healing

  at 6 months

• functional outcome

  6 months

Study Arms (1)

intervention

EXPERIMENTAL

Patients enrolled in the study will be treated for their anal fistula by surgical closure of the internal opening, debridement of the fistula and injection of patients own stem cells enriched fatty tissue around the fistula.

Procedure: stem cells injection

Interventions

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.

Also known as: liposuction, fistula closure

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Rectal Fistula; Crohn Disease

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Karam Matlub, MD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: afdelingslæge

Model Details: pilot study with a maximum of 20 patients

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 15, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)