Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perianal Fistula Treatment With Autologous Adipose Tissue Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913910
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Gabriele Naldini, Azienda Ospedaliero, Universitaria Pisana

Brief Summary:
The study aims to evaluate the efficacy of the local injection of autologous micro-fragmented adipose tissue obtained with the Lipogems®system in patients with trans-sphincteric fistulas untreatable with fistulotomy.

Condition or disease Intervention/treatment
Perianal Fistula Procedure: Lipogems

Detailed Description:

STUDY BACKGROUND

Perianal fistulas are diseases that, by their nature, do not tend to heal spontaneously and are very rarely cured with medical treatment. Their healing is usually pursued through surgery, which often needs to be repeated due to the natural tendency of the fistulas to recur. A surgical treatment that is currently able to provide a high chance of healing is fistulotomy which, however, can injure the anal sphincter and may result in degrading scars and possible fecal incontinence. One possible strategy could be the lipofilling, i.e., autologous adipose tissue transplant containing, among the many, pericytes and progenitor cells, including adult mesenchymal stem cells.

STUDY DESIGN

This is a no profit interventional prospective multicenter study without drugs where 100 patients (10 each participant centre) with a diagnosis of trans-sphincteric anal fistula that is not suitable to be laid open will be enrolled.

After the enrolment, medical history and clinical data will be collected and pre-operatory exams will be performed.

METHODS

- Harvesting of the adipose tissue

The lower/lateral abdomen or, eventually, the inner/outer thigh will be chosen as donor site for adipose tissue harvesting under general or spinal anaesthesia. Before the harvesting, the donor site will be injected with 100 cc of Klein Solution (500 cc saline, 1 cc epinephrine 1/1000 IU, and 40 cc lidocaine 2%) using a disposable 17 gauge blunt cannula connected to a 60-cc luer-lock syringe. The fat will be then harvested (50-100 cc) using a 13 gauge blunt cannula connected to a 20-ml VacLok® syringe.

- Processing of the adipose tissue with the Lipogems® device

The harvested fat will be immediately processed in the Lipogems® processing kit (Lipogems International Spa, Milan, Italy). Lipogems® is a disposable device that mechanically reduces the size of the adipose tissue clusters while eliminating oily substances and blood residues with pro-inflammatory properties. The entire process is carried out in one surgical step in complete immersion in physiological solution minimizing any traumatic action on the cells and microarchitecture. The processed micro-fragmented fat will be collected in a 60-cc syringe and positioned to decant the excess of saline solution. At the end, the product will be transferred in several 5-cc syringes to be re-injected in the patient.

- Surgical procedure and micro-fragmented adipose tissue (Lipogems®) injection

The micro-fragmented autologous adipose tissue will be injected with wheals of no more than 1cc in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula tract and external orifice.

- Follow-up visits and outcome measures

All patients will be assessed at 7 days, 1, 3, 6 and 12 months after the procedure.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Treatment of Perianal Fistulas Through Injection of Autologous and Micro-fragmented Adipose Tissue: a Prospective Multicentre Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort Intervention/treatment
Lipogems
Lipogems injection in the internal orifice, mucosal, submucosal and muscular layer, in the fistula tract and external orifice.
Procedure: Lipogems
Autologous micro-fragmented adipose tissue is injected in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula tract and external orifice in addition to anal flap.




Primary Outcome Measures :
  1. Healing [ Time Frame: 12 months ]
    Closing of the fistula tract (internal and external orifice)


Secondary Outcome Measures :
  1. Safety collecting all types of adverse events [ Time Frame: 12 months ]
    All types of adverse events intra-, peri-, or post-operative will be collected

  2. Pain assessed using the Visual Analogue Scale (VAS) for pain [ Time Frame: 12 months ]
    Pain will be assessed using the Visual Analogue Scale for pain (VAS 0-10), where 0 is no pain and 10 is the maximum pain.

  3. Continence [ Time Frame: 12 months ]

    Continence will be assessed with the Wexner Continence Grading Scale. The score takes into account the type and frequency of incontinence and the extent to which it alters the patient's life.

    This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).


  4. Patient's satisfaction [ Time Frame: 12 months ]
    Patient's satisfaction will be evaluated using a visual analogue scale 0-5, where 0 is no satisfaction and 5 is maximum satisfaction.

  5. Non inferiority compared with the Advancement flap technique [ Time Frame: 12 months ]
    Non-inferiority will be determined comparing healing rate of Lipogems with retrospective data on the advancement flap.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of transphincteric anal fistula that is not suitable to be laid open.
Criteria

Inclusion Criteria:

  • Patients of both sexes, aged over 18 and under 80 years old.
  • Diagnosis, confirmed by standard methods (magnetic resonance and/or trans anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open) without any secondary tracts and no active septic processes, performed 2-4 weeks after the first perianal access drainage procedure and fistulectomy, with positioning of a drainage seton.
  • Seton placed at least 4-6 weeks previously
  • No previous sphincter saving procedures for the anal fistula
  • No limitations to a periodic follow-up lasting for a total of 12 months
  • Informed consent form signed

Exclusion Criteria:

  • Patients with multiple fistulas
  • Active septic process
  • Patients unable to follow the pathway required by the protocol
  • Patients with active Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus infections
  • Patients with Irritable Bowel Syndrome
  • Patients with rectal-vaginal fistulas
  • Patients with a history of cancer lasting less than 5 years
  • Patients undergoing cortisone and/or immunosuppressive and/or anticoagulant therapy
  • Patients with a history rectal or pelvic radiotherapy
  • Pregnant women
  • Patients with connective tissue diseases and/or coagulation diseases and/or uncompensated diabetes mellitus
  • Failure to sign the informed consent form

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): NCT03913910


Contacts
Layout table for location contacts
Contact: Gabriele Naldini, MD +39050997802 gabrielenaldini65@gmail.com
Contact: Alessandro Sturiale, MD +39050997814 alexstur@yahoo.it

Locations
Layout table for location information
Italy
AOU Pisana - Cisanello Recruiting
Pisa, Toscana, Italy, 56124
Contact: Gabriele Naldini, MD       gabrielenaldini65@gmail.com   
Contact: Alessandro Sturiale    0039 3311372249    alexstur@yahoo.it   
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana

Publications:

Layout table for additonal information
Responsible Party: Gabriele Naldini, Principal Investigator, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT03913910     History of Changes
Other Study ID Numbers: AOUPisana_1
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gabriele Naldini, Azienda Ospedaliero, Universitaria Pisana:
Autologous micro-fragmented adipose tissue
Perianal fistula
Lipogems
Mesenchymal Stem Cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases