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

Recruiting now · Not applicable

Conditions studied: Anal Fistula

In brief

The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as compared to a control for managing transsphincteric and intersphinsteric anal fistulas. The main questions it aims to answer are: Assess the safety and efficacy of RD2 Ver.02 in anal fistula application, compared to control. Complication rate by 6 months of anal fistula treatment with RD2 Ver.02 compared to control. Recurrence of anal fistula at 12 months post-treatment Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control. Patients will be randomized in to 2 arms. For all patients, blood will be drawn to ensure the blinding of the patients, the fistula will be evaluated and debrided, and then the internal fistula opening will be suture-closed, and a water leak test will be performed to ensure sealing. Following the water leak test, In the treatment arm, the patient's own coagulating blood will be applied into the entire fistula tract, allowing it to clot and serve as a provisional matrix inside the fistula tract. In the control arm, the blood sample will be discarded and saline will be applied to the fistula tract.

Key facts

Study ID: NCT05641844
Run by: RedDress Ltd.
People needed: 110
Starts: 2024-01-20
Expected to finish: 2028-06-30
Last updated by the study team: 2025-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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:
Serum Creatinine levels >1.5 times the upper limit of normality (ULN)
Total bilirubin >1.5 times the ULN (unless predominantly non conjugated due to documented history of Gilbert's syndrome)
AST/ ALT >3.0 times the ULN
Hemoglobin <10.0 g/dL
Platelets <150.0 x109/L
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.

Where it is running

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

Full record on ClinicalTrials.gov

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