What side effects are associated with this type of intervention?

Common treatments for anal fistulas, such as autologous PRP and micronized acellular porcine urinary bladder matrix, have specific side effects. Autologous PRP, which promotes tissue healing and reduces inflammation, can cause pain at the injection site, infection, and allergic reactions. Micronized acellular porcine urinary bladder matrix, which provides a scaffold for tissue regeneration, may lead to complications like infection, immune response, and graft rejection. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for anal fistulas that directly match the use of autologous PRP or micronized acellular porcine urinary bladder matrix. These treatments are still largely in the experimental or investigational stages. Autologous PRP is known for promoting tissue healing and reducing inflammation, while micronized acellular porcine urinary bladder matrix provides a scaffold for tissue regeneration and repair. Current standard treatments for anal fistulas typically involve surgical interventions, such as fistulotomy or seton placement, rather than biologic therapies.

What other types of research exist?

Promising novel alternatives for treating anal fistulas include stem cell therapy, which utilizes mesenchymal stem cells to promote tissue regeneration and reduce inflammation, and gene therapy approaches, such as the use of genetically modified autologous cultured skin grafts to enhance tissue repair and healing. Additionally, advanced biomaterials like bioengineered scaffolds that incorporate growth factors or other bioactive molecules are being explored for their potential to improve outcomes in anal fistula repair.

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Biologic Augmented Repair for Anal Fistulas (BIO RAMP Trial)

N/A

Recruiting

Led By Jeffrey L Van Eps, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.

Summary

This trial is testing whether adding PRP and UBM to surgery can better treat complex anal fistulas compared to surgery alone. PRP uses the patient's own blood to help heal faster, while UBM provides a structure for new tissue to grow. The study aims to see if these additions reduce pain, improve healing, and are cost-effective. PRP has been studied for its efficacy in treating anal fistulas, showing potential benefits in healing.

Who is the study for?

This trial is for English or Spanish speakers who can consent and have complex anal fistulas needing surgery. Surgeons must do at least 3 repairs a year. Patients should be willing to have temporary drainage before repair but can't join if they can't follow up for a year, have platelet disorders, very low platelet counts, take certain blood thinners, or their fistula is due to IBD, cancer, or radiation.

What is being tested?

The study tests if adding autologous PRP (from the patient's own blood) and/or porcine urinary bladder matrix improves healing after anal fistula surgery compared to usual care alone. It looks at recurrence rates, quality of life post-surgery, pain levels, fecal continence and cost-effectiveness.

What are the potential side effects?

Potential side effects may include discomfort from PRP injections and risks associated with surgical procedures such as infection or issues with wound healing. The specific side effects of the urinary bladder matrix are not detailed but could involve similar surgical risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire

Number of participants with fistula recurrence

Secondary study objectives

Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool

Number of participants who have post operative pain as assessed by the visual analog scale (VAS)

The relative cost utility of the different treatment strategies as assessed by a questionnaire

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Surgery plus platelet-rich plasma (PRP)Experimental Treatment2 Interventions

Group II: Surgery plus matrixExperimental Treatment2 Interventions

Group III: Surgery plus PRP plus matrix materialExperimental Treatment3 Interventions

Group IV: SurgeryPlacebo Group1 Intervention

Control patients will receive usual standard of care surgical repair of their complex fistula by The ligation of intersphincteric tract (LIFT) or advancement flap technique without any biologic adjunct.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matrix

2015

N/A

~10

Surgery

2000

Completed Phase 3

~2490

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for anal fistulas, such as Autologous Platelet-Rich Plasma (PRP) and Micronized Acellular Porcine Urinary Bladder Matrix (UBM), work by promoting tissue healing and providing a scaffold for tissue regeneration. PRP delivers growth factors and cytokines that accelerate the body's natural healing processes and reduce inflammation. UBM supports the growth of new, healthy tissue to replace damaged areas. These mechanisms are essential for anal fistula patients as they enhance healing, reduce recurrence rates, and improve overall quality of life.

Meta-analysis of platelet-rich plasma therapy for anal fistula.Fistula tract curettage and the use of biological dermal plugs improve high transsphincteric fistula healing in an animal model.