Anal Fistula Clinical Trial
— CATOfficial title:
Efficacy and Safety of Treatment of Complex Anal Fistulas Not Associated With Crohn's Disease Using Centrifuged Adipose Tissue Containing Progenitor Cells: a Randomized Controlled Clinical Trial
Verified date | March 2020 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the treatment of complex anal fistulas transplant of freshly collected autologous adipose
tissue mechanically fragmented or centrifuged adipose tissue (CAT) might be an alternative to
in vitro expanded autologous or allogeneic adipose-derived stem cells, showing remarkable
efficacy in diverse therapeutic indications.
The aim of our study is to evaluate randomly the efficacy and safety of the use of CAT in the
healing process of complex anal fistulas, except for Crohn's disease (CD) related fistulas.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients aged 18 years or older with complex perianal fistulas Exclusion Criteria: Inflammatory bowel diseases, Crohn's Disease (CD) or Ulcerative Colitis (UC) Hepatitis B or C virus Infection with Human immunodeficiency virus Surgery for a malignant tumor during the previous 5 years (excluding in situ carcinoma) Previous pelvic radiotherapy Autoimmune disease Active tuberculosis Symptoms of septicemia Breastfeeding or pregnant women Women unwilling to use contraception during the study Psychiatric disorders Alcoholism Drug dependency Allergy to local anesthetics |
Country | Name | City | State |
---|---|---|---|
Italy | Simona Ascanelli | Ferrara |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara |
Italy,
Aust L, Devlin B, Foster SJ, Halvorsen YD, Hicok K, du Laney T, Sen A, Willingmyre GD, Gimble JM. Yield of human adipose-derived adult stem cells from liposuction aspirates. Cytotherapy. 2004;6(1):7-14. — View Citation
Dige A, Hougaard HT, Agnholt J, Pedersen BG, Tencerova M, Kassem M, Krogh K, Lundby L. Efficacy of Injection of Freshly Collected Autologous Adipose Tissue Into Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2019 Jun;156(8):2208-221 — View Citation
García-Olmo D, García-Arranz M, Herreros D, Pascual I, Peiro C, Rodríguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. — View Citation
Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 J — View Citation
Ibatici A, Caviggioli F, Valeriano V, Quirici N, Sessarego N, Lisa A, Klinger F, Forcellini D, Maione L, Klinger M. Comparison of cell number, viability, phenotypic profile, clonogenic, and proliferative potential of adipose-derived stem cell populations — View Citation
Laureti S, Gionchetti P, Cappelli A, Vittori L, Contedini F, Rizzello F, Golfieri R, Campieri M, Poggioli G. Refractory Complex Crohn's Perianal Fistulas: A Role for Autologous Microfragmented Adipose Tissue Injection. Inflamm Bowel Dis. 2020 Jan 6;26(2): — View Citation
Limura E, Giordano P. Modern management of anal fistula. World J Gastroenterol. 2015 Jan 7;21(1):12-20. doi: 10.3748/wjg.v21.i1.12. Review. — View Citation
Naldini G, Sturiale A, Fabiani B, Giani I, Menconi C. Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility. Tech Coloproctol. 2018 Feb;22(2):107-113. doi: 10.1007/s10151-018-17 — View Citation
Park SR, Kim JW, Jun HS, Roh JY, Lee HY, Hong IS. Stem Cell Secretome and Its Effect on Cellular Mechanisms Relevant to Wound Healing. Mol Ther. 2018 Feb 7;26(2):606-617. doi: 10.1016/j.ymthe.2017.09.023. Epub 2017 Oct 5. — View Citation
Pu LL, Coleman SR, Cui X, Ferguson RE Jr, Vasconez HC. Autologous fat grafts harvested and refined by the Coleman technique: a comparative study. Plast Reconstr Surg. 2008 Sep;122(3):932-7. doi: 10.1097/PRS.0b013e3181811ff0. — View Citation
Vezzani B, Shaw I, Lesme H, Yong L, Khan N, Tremolada C, Péault B. Higher Pericyte Content and Secretory Activity of Microfragmented Human Adipose Tissue Compared to Enzymatically Derived Stromal Vascular Fraction. Stem Cells Transl Med. 2018 Dec;7(12):87 — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | postoperative pain | postoperative pain measured by Visual Analogue Scale (0-10) for 2 weeks after surgery to evaluate whether CAT injection could modulate pain | 2 weeks | |
Other | recurrence at 6 months | to evaluate the long-term efficacy of CAT injection | 6 months | |
Primary | Fistula healing rate within 6 months after surgery | Fistula healing was defined as the absence of any anal symptom, with no discharge from the fistula and a closed external opening confirmed on clinical evaluation. Fistula healing was eventually confirmed by a pelvic MRI at 3 months after surgery | up to 6 months | |
Secondary | Safety of autologous adipose tissue injection | Safety was evaluated by the overall incidence and severity of Adverse Events (AEs) up to 4 weeks following surgery. | 4 weeks |
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