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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Healing fistula [ Time Frame: 62 weeks ]
- Morbidity [ Time Frame: 62 week ]
- Quality of life modification [ Time Frame: 62 week ]
- Relation between Crohns Disease Activity Index and fistula healing [ Time Frame: 62 week ]
- Mortality [ Time Frame: 62 week ]
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
|Contact: Paolo Bertoliemail@example.com|
|Bergamo, Italy, 24127|
|Contact: Paolo Bertoli 3496153508 firstname.lastname@example.org|