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.
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.
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.