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Autologous Adipose-derived Stem Cells (ASCs) for the Treatment of Perianal Fistula in Crohn Disease: A Pilot Study (ASPEFIC1)

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ClinicalTrials.gov Identifier: NCT02403232
Recruitment Status : Unknown
Verified March 2015 by Paolo Bertoli, Papa Giovanni XXIII Hospital.
Recruitment status was:  Recruiting
First Posted : March 31, 2015
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Paolo Bertoli, Papa Giovanni XXIII Hospital

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.


Condition or disease Intervention/treatment Phase
Perianal Fistula Crohn Disease Procedure: ASCs injection Device: ASCs injection Device: Closure of fistula tract. Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Adipose-derived Stem Cells (ASCs) for the Treatment of Perianal Fistula in Crohn Disease: A Pilot Study
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASCs injection
Autologous adipose-derived stem cells (ASCs) injection with LIPOGEMS system.
Procedure: ASCs injection

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.


Device: ASCs injection
In general anesthesia subcutaneous abdominal adipose tissue will be collected by LIPOGEMS system to prepare ASCS.
Other Name: LIPOGEMS system

Device: Closure of fistula tract.
A SALVECOLL-E paste will be injected into the fistula tract.
Other Name: SALVECOLL-E paste




Primary Outcome Measures :
  1. Healing fistula [ Time Frame: 62 weeks ]

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 62 week ]
  2. Quality of life modification [ Time Frame: 62 week ]
  3. Relation between Crohns Disease Activity Index and fistula healing [ Time Frame: 62 week ]
  4. Mortality [ Time Frame: 62 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403232


Contacts
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Contact: Paolo Bertoli 00393496153508 paolo.bertoli@alice.it

Locations
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Italy
Paolo Bertoli Recruiting
Bergamo, Italy, 24127
Contact: Paolo Bertoli    3496153508    paolo.bertoli@alice.it   
Sponsors and Collaborators
Papa Giovanni XXIII Hospital
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Responsible Party: Paolo Bertoli, MD, Papa Giovanni XXIII Hospital
ClinicalTrials.gov Identifier: NCT02403232    
Other Study ID Numbers: 01
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Paolo Bertoli, Papa Giovanni XXIII Hospital:
Autologous adipose-derived stem cells
Additional relevant MeSH terms:
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Crohn Disease
Rectal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases