Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing
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.
Timeline
- Start
- 2024-11-25
- Primary completion
- 2026-07
- Completion
- 2026-10
Publications
- Kuo MC, Younan SA, Lempicki MD, Hawkins AT, Smith J, Shirey-Rice JK, Pulley JM, Lynch SE, Ueland TE, Khan A, Clark CR, Blette BS. Study protocol and statistical analysis plan for 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. medRxiv [Preprint]. 2026 Jun 24:2026.06.22.26356267. doi: 10.64898/2026.06.22.26356267.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhPDGF-BB | Protein / enzyme biologic | 0.3 mg/ml | — |