Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing

NCT06632418 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 240585
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anal Fistula; Complex Perianal Fistula

Keywords

Platelet-derived Growth Factor; Type 1 Collagen; Anal fistula plug

Outcome Measures

Primary Outcomes (1)

• Number of Participants Without Treatment-Related Serious Adverse Events (SAEs) at 3 Months

  Proportion of participants with procedural success as defined by implantation of the device without device-related SAEs.

  Month 3

Secondary Outcomes (9)

• Number of Participants Who Achieved Fistula Healing at 3 Months

  Month 3

• Number of Participants With Fistula Recurrence at 6 Months

  Month 6

• Change from Baseline in Symptoms at Week 24

  From enrollment to week 24

• Change from Baseline in Pain on an 11-Point Scale at Week 24

  From enrollment to week 24

• Change from Baseline in Incontinence on a 5-Point Scale at week 24

  From enrollment to week 24

Other Outcomes (1)

• Crossover Outcomes

  Month 3

Study Arms (2)

Routine care

NO INTERVENTION

Participants receive routine care for their fistula.

rhPDGF-BB-enhanced collagen plug

EXPERIMENTAL

Participants receive collagen plug saturated with rhPDGF-BB.

Drug: RhPDGF-BB

Interventions

RhPDGF-BB DRUG

0.3 mg/mL rhPDGF-BB

rhPDGF-BB-enhanced collagen plug

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical conditions that would, in the opinion of the investigator or treating provider, compromise the safety of the individual with study participation and/or the ability of the individual to follow study protocol
• Genito-urinary fistulization, including rectovaginal (i.e., fistulas that transverse the vaginal canal)
• Presence of an ileal anal pouch
• Prior surgical procedure (i.e., Ligation of Intersphincteric Fistula Tract or Endorectal Advancement Flap) for the target fistula or a perianal procedure that resulted in a large soft tissue defect within 6 months prior to screening visit
• Known allergic reactions to porcine collagen or yeast-derived products
• Currently enrolled in a drug or device trial or within 30 days of last investigational drug or device administration at baseline visit where investigational treatment (drug or device) was placed in or near the fistula tract or may potentially interact with study treatment
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• Active infection at the application site
• The presence of malignant neoplasms at the application site
• Prior radiation therapy at the application site

Sponsors & Collaborators

• Alexander Hawkins: lead
• Lynch Regenerative Medicine, LLC: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Younan SA, Ueland TE, Savitz BL, Jerome RN, Budine TD, Hawkins AT, Thayer WP, Wu DT, Lynch SE, Clark CR. Recombinant Platelet-Derived Growth Factor in Tissue Repair: A Review Exploring Frontiers in Regenerative Medicine. Plast Reconstr Surg. 2026 Apr 1;157(4):759-770. doi: 10.1097/PRS.0000000000012426. Epub 2025 Sep 15.

  PMID: 40952157 DERIVED

MeSH Terms

Conditions

Rectal Fistula; Osteogenesis Imperfecta, Type IV

Interventions

Becaplermin

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors

Study Officials

• Alexander T Hawkins

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Colorectal Research Center

Model Details: Participants in the control arm of the study who have not healed by the time they reach the primary endpoint will have the option to crossover to the investigational arm and receive the investigational intervention. Their outcome measures will be tracked and documented, but their results will not be included in the initial analyses of the original randomized participant data. This will be considered extended open-label use of the investigational intervention and their outcome measures will be analyzed and reported separately.

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 9, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)