Autologous Adipose-derived Stem Cells (ASCs) for the Treatment of Perianal Fistula in Crohn Disease: A Pilot Study

NCT02403232 | Unknown Phase 2

• 1 other identifier: 01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea, respectively. Uncontrolled chronic inflammation finally causes various complications in intestine such as bowel obstruction, fistulas, abscesses, and anal fissures. The incidence of perianal fistula was reported in 13%- 39% of patients with Crohn's disease. Medical treatment for Crohn's fistulae initially focused on surgical intervention accompanied by symptomatic treatment with antibiotics and immunosuppressants. The most serious problem after surgical intervention is the relatively high incidence of postoperative anal incontinence caused by sphincter injury during the procedure. Conversely, available pharmacological therapies for Crohn's fistulae based on biologic agents such as infliximab do not generally reach ideal goal of treatment (e.g., complete closure of the fistula). A high recurrence rate after treatment with infliximab has also been reported, even after long-term maintenance therapy, which suggests that infliximab monotherapy does not provide adequate healing. The ACCENT II study demonstraded a complete fistula healing in 25% of patients. To reach a better clinical outcome, combination treatment with infliximab and surgical intervention is highly recommended for management of Crohn's fistulae. Nonetheless, even this strategy does not result in a satisfactory healing for many patients. The ideal therapeutic goal of treatment is not only complete closure of the fistula without recurrence but also preservation of anal sphincter function. Unfortunately, currently available medical or surgical treatment is not likely to offer a cure for perianal fistulae and, as noted above, recurrence is frequently reported. Together with active research in the field of bone marrow-derived mesenchymal stem cells (BM-MSCs) and hematopoietic stem cells, autologous or allogenic adipose tissue-derived stem cells (ASCs) have been studied for management of Crohn's disease and other disorders. Of particular relevance to this study, ASCs could be considered to be safe and efficacious therapeutic tools for the treatment of Crohn's fistulae. Importantly, ASCs do not cause fecal incontinence after injection into the lesion site in Crohn's disease patients. A phase I dose-escalation clinical study with ASCs manufactured by Anterogen Co., Ltd. (Seoul, Korea) demonstrated the safety and therapeutic potential of these cells for the treatment of Crohn's fistulae. A phase II study demonstrated a good rate of cronh's related fistula closure using a ASCS injection. Actually the best accepted treatment of Crohn related perianal fistula, is the surgical procedure in association whit medical therapy.

Conditions

Perianal Fistula; Crohn Disease

Keywords

Autologous adipose-derived stem cells

Outcome Measures

Primary Outcomes (1)

• Healing fistula

  62 weeks

Secondary Outcomes (4)

• Morbidity

  62 week

• Quality of life modification

  62 week

• Relation between Crohns Disease Activity Index and fistula healing

  62 week

• Mortality

  62 week

Study Arms (1)

ASCs injection

EXPERIMENTAL

Autologous adipose-derived stem cells (ASCs) injection with LIPOGEMS system.

Procedure: ASCs injection; Device: ASCs injection; Device: Closure of fistula tract.

Interventions

ASCs injection PROCEDURE

In the infiltration step, adrenalin in a saline solution is infiltrated using a 19-cm specially designed disposable blunt cannula. The aspiration step is performed by a luer-lock syringe connected to a disposable 19-cm blunt cannula. The harvested lipoaspirate can be progressively put into the device using multiple 10-cc syringes. Subsequently, in lithotomy position, a seton will be removed and a fistula tract will be thoroughly curetted and irrigated. After a mucosal flap preparing round the internal opening, cells will be injected in the perianal adipose tissue.

ASCs injection

Closure of fistula tract. DEVICE

A SALVECOLL-E paste will be injected into the fistula tract.

Also known as: SALVECOLL-E paste

ASCs injection

Eligibility Criteria

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

You may qualify if:

• Patients aged \> 18 years old
• Diagnosis of perianal fistulae associated with Crohn's disease.

You may not qualify if:

• Patients aged \< 18 years old
• Informed consent refusal
• Medical or family history of variant Creutzfeldt-Jakobs disease
• Activated sever Crohn's disease
• Perianal fistulae \>2 cm in diameter
• Autoimmune disease or inflammatory bowel disease other than Crohn's disease
• Infectious disease including hepatitis B virus, hepatitis C virus and immunodeficiency virus infection
• Active tuberculosis
• Signs of septicemia
• Patients treated with Infliximab within 3 months prior to ASC treatment.
• Technically difficult adipose tissue collection due to low levels of fat tissue.
• Pregnancy

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Paolo Bertoli

Bergamo, Italy, 24127, Italy

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Paolo Bertoli

CONTACT

00393496153508; paolo.bertoli@alice.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 31, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

IT (1)