Evaluating RD2 Ver.02 for managing anal fistulas

A Prospective, Multi-Center, Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02, For the Management of Anal Fistulas

This study is testing a new treatment called RD2 Ver.02 to see if it can help people with certain types of anal fistulas heal better than a saline solution.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RedDress Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 10 sites (Los Angeles, California and 9 other locations)
• Trial ID: NCT05641844 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and efficacy of RD2 Ver.02, an autologous treatment, compared to a control in patients with transsphincteric and intersphincteric anal fistulas. Participants will be randomized into two groups, where one group receives RD2 Ver.02 while the other receives saline. The study aims to evaluate complication rates, recurrence of anal fistulas, and incidence of perirectal infections over a specified follow-up period. Blood samples will be collected to maintain blinding throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific types of anal fistulas who prefer a minimally invasive treatment approach.

Not a fit: Patients who require invasive surgical procedures or have underlying abscesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a minimally invasive option for managing anal fistulas, potentially reducing complications and recurrence rates.

How similar studies have performed: While this approach is innovative, it is not widely tested in previous studies, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

* Subject is ≥18 years of age
* Subject has a transsphincteric or long intersphincteric anal fistula (\>1.5 cm), with a seton in place for a minimum of 1 month, deemed eligible for primary or repeat fistula repair by anorectal advancement flap or LIFT: Anterior, posterior or lateral fistula, first or recurrent, at any position circumferentially, with one external opening and one internal opening.
* Subjects is unable or unwilling to receive invasive surgical procedures, anorectal advancement flap or LIFT procedure, and is opting for minimally invasive technique of anal fistula management (i.e., fistula tract debridement and suturing of internal opening).
* 2.1.4 Prior to enrollment, during the preceding 3 months from Treatment Visit, subject must undergo a pelvic MRI to evaluate eligibility criteria unable to be assessed clinically.
* Female subjects who are capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study and for 6 months following study procedure (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women)

Exclusion Criteria:

* Subject who has a life expectancy of less than 24 months.
* Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form.
* Cannot withdraw blood in the required amount (up to 15 mL).
* Women who are pregnant or currently breast feeding.
* Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (more than 10mg per day).
* Multiple fistula tracts, as confirmed on pelvic MRI
* Short fistula tract that in the surgeon's opinion are amenable to fistulotomy
* Active infection including perianal infection, and/or any active systemic or local infection.
* Presence of a perirectal abscess on pelvic MRI
* Presence of dominant luminal active Crohn's disease, validated by recent colonoscopy from preceding 12 months, requiring immediate therapy
* Rectal and/or anal stenosis and / or active proctitis, if this means a limitation for any surgical procedure.
* Known allergies or hypersensitivity to any of the following: antibiotics including but not limited to penicillin, streptomycin, gentamicin, aminoglycosides; Human Serum Albumin (HSA); Dulbecco Modified Eagle's Medium (DMEM); materials of bovine origin; local anaesthetics or gadolinium (MRI contrast); Known hypersensitivity to reagents and components of RD2 Ver.02 including calcium gluconate, Kaolin or citrate and ethylene oxide.
* Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements, or severe claustrophobia).
* Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking Coumadin, Aspirin, Plavix (Clopidogrel), Eliquis or Pradaxa will not be excluded.
* Patients with increased risk for the surgical procedure or major alteration of any of the following laboratory tests:

  1. Serum Creatinine levels \>1.5 times the upper limit of normality (ULN)
  2. Total bilirubin \>1.5 times the ULN (unless predominantly non conjugated due to documented history of Gilbert's syndrome)
  3. AST/ ALT \>3.0 times the ULN
  4. Hemoglobin \<10.0 g/dL
  5. Platelets \<150.0 x109/L
  6. Albuminemia \<3.0 g/dL.
* Patients who do not wish to or cannot comply with study procedures.
* Patients currently receiving or having received within 12 months prior to enrolment into this clinical study, any investigational drug.
* Subjects who need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or for whom such surgery is foreseen in this region in the 24 weeks after treatment administration.
* Contraindication to the anesthetic procedure.
* Subject with a diagnosis of Ulcerative Colitis
* Subject with malignancy, undergoing active treatment
* Rectovaginal fistula
* History of pelvic radiation

Where this trial is running

Los Angeles, California and 9 other locations

• Karen Zaghiyan, M.D — Los Angeles, California, United States (Completed)
• Cleveland Clinic — Weston, Florida, United States (Recruiting)
• University of Chicago — Chicago, Illinois, United States (Recruiting)
• Franciscan Health — Indianapolis, Indiana, United States (Recruiting)
• Umass — Worcester, Massachusetts, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Lenox Hill Hospital — New York, New York, United States (Recruiting)
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Recruiting)
• Brown surgical associates — Providence, Rhode Island, United States (Recruiting)
• Sheba Medical Center — Ramat Gan, Israel (Recruiting)

Study contacts

• Study coordinator: Sharon Sirota

Conditions Anal Fistula