NCT02889848

Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)

Completed Phase 1 Last updated 10 July 2019

What this trial tests

Phase 1 trial testing Saline in Fibroids, Uterine in 15 participants. Completed in 15 November 2018.

Timeline

27 October 2016

Primary endpoint
5 October 2018

15 November 2018

Quick facts

Lead sponsor	Advance Biofactures Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	27 October 2016
Primary completion	5 October 2018
Estimated completion	15 November 2018
Sites	1 location across United States

Drugs / interventions tested

• Saline
• EN3835 — full drug profile →

Conditions studied

• Fibroids, Uterine — all drugs for Fibroids, Uterine →
• Leiomyoma — all drugs for Leiomyoma →

Sponsor

Advance Biofactures Corporation

Who can join

Adults 35 to 50, female only, with Fibroids, Uterine or Leiomyoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot study evaluates the safety and tolerability of a single injection of collagenase enzyme directly into a uterine fibroid in subjects already selected for hysterectomy or myomectomy.

Fibroids contain excessive amounts of collagen and it is possible that digestion of collagen may be beneficial in reducing pain and bleeding associated with fibroids.

Three subjects will be injected with saline only to evaluate the safety and effectiveness of the injection method. Additional subjects will then be injected with increasing doses of study drug.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of collagen in cancer: from bench to bedside.
   Xu S, Xu H, Wang W, Li S, et al · · 2019 · cited 545× · PMID 31521169 · DOI 10.1186/s12967-019-2058-1
2. Comprehensive Review of Uterine Fibroids: Developmental Origin, Pathogenesis, and Treatment.
   Yang Q, Ciebiera M, Bariani MV, Ali M, et al · · 2022 · cited 233× · PMID 34741454 · DOI 10.1210/endrev/bnab039
3. The strategies to cure cancer patients by eradicating cancer stem-like cells.
   Mai Y, Su J, Yang C, Xia C, et al · · 2023 · cited 53× · PMID 37853413 · DOI 10.1186/s12943-023-01867-y
4. Extracellular matrix and Hippo signaling as therapeutic targets of antifibrotic compounds for uterine fibroids.
   Islam MS, Afrin S, Singh B, Jayes FL, et al · · 2021 · cited 36× · PMID 34323413 · DOI 10.1002/ctm2.475
5. Deciphering mechanical cues in the microenvironment: from non-malignant settings to tumor progression.
   Zhu Y, Chen J, Chen C, Tang R, et al · · 2025 · cited 14× · PMID 39849659 · DOI 10.1186/s40364-025-00727-9
6. A Phase I Clinical Trial to Assess Safety and Tolerability of Injectable Collagenase in Women with Symptomatic Uterine Fibroids.
   Singh B, Sims H, Trueheart I, Simpson K, et al · · 2021 · cited 12× · PMID 33914296 · DOI 10.1007/s43032-021-00573-8
7. Summary of the Proceedings of the Basic Science of Uterine Fibroids Meeting: New Developments February 28, 2020.
   Leppert PC, Al-Hendy A, Baird DD, Bulun S, et al · · 2021 · cited 8× · PMID 34124698 · DOI 10.1016/j.xfss.2020.11.001
8. Targeting collagen to optimize cancer immunotherapy.
   Wang Y, Zhang F, Qian Z, Jiang Y, et al · · 2025 · cited 7× · PMID 40721833 · DOI 10.1186/s40164-025-00691-y