A Randomized Controlled Trial Evaluating the Safety and Feasibility of the Recombinant Human Platelet-derived Growth Factor B (rhPDGF-BB)-enhanced Collagen Plug for Complex Perianal Fistula Healing

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The average success rate for healing and remission of complex perianal fistulas, idiopathic or Crohn's-related, is approximately 50%. These abnormal connections between the rectum and the outside skin remain a major clinical challenge in need of new treatments aimed at tissue repair. Platelet-derived growth factor drives wound healing and tissue regeneration, and manufactured PDGF is currently used to heal diabetic foot ulcers and regenerate bone in periodontal and orthopedic patients. Manufactured recombinant human PDGF has the potential to improve the success rate for complete healing of complex perianal fistulas, reduce the recurrence rate due to reopening of the fistula tract, and avoid complications associated with routine surgical interventions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Diagnosis of a single tract perianal fistula not amenable to fistulotomy as determined by the supervising surgeon

• Fistula must currently have a draining seton in place

• Aged \>21 years old

• Willing and able to provide informed consent and to comply with study protocol and follow-up

• Stated willingness to comply with all study procedures and availability for the duration of the study

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Jacob J Smith
jacob.smith@vumc.org
615-875-7466
Backup
Cyndi R Clark, PhD
cyndi.r.clark@vumc.org
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2026-02
Participants
Target number of participants: 12
Treatments
No_intervention: Routine care
Participants receive routine care for their fistula.
Experimental: rhPDGF-BB-enhanced collagen plug
Participants receive collagen plug saturated with rhPDGF-BB.
Related Therapeutic Areas
Sponsors
Collaborators: Lynch Regenerative Medicine, LLC
Leads: Alexander Hawkins

This content was sourced from clinicaltrials.gov