NCT05437757

Scaffold-guided Breast Surgery

Active, enrolled NA Last updated 4 July 2025

What this trial tests

NA trial testing Surgical implantation of the PCL Breast scaffold with autologous fat grafting in Breast Implant Revision in 19 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 June 2022

Primary endpoint
17 December 2025

17 December 2025

Quick facts

Lead sponsor	BellaSeno Pty Ltd
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	19
Start date	15 June 2022
Primary completion	17 December 2025
Estimated completion	17 December 2025
Sites	1 location across Australia

Drugs / interventions tested

• Surgical implantation of the PCL Breast scaffold with autologous fat grafting

Conditions studied

• Breast Implant Revision — all drugs for Breast Implant Revision →
• Congenital Breast Defect Correction — all drugs for Congenital Breast Defect Correction →

Sponsor

BellaSeno Pty Ltd — full company profile →

Who can join

18 and older, female only, with Breast Implant Revision or Congenital Breast Defect Correction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a resorbable frame to support this growth of cells. The scaffold will be resorbed within at least 3 years. The main assumption of this clinical trial is that the method used is safe and effective for treatment of women requiring a silicone implant and /or correction of breast defect and/or deformity. The other assumption is that this method is applicable to a wider range of tissue defects, such as breast reconstruction after breast tissue removal. The new method is called '3D printed scaffold-based soft tissue regeneration', and uses a combination of own fat cells (called adipocytes) with a 3D printed scaffold to support soft tissue regeneration using the natural healing processes in their body. This substance is resorbable and is similar to the substance used for sutures and stitches that are dissolvable or resorbable in the body. The substance used for the scaffold is already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the their own tissue in its place. The combination of scaffold implantation and their own fat cells is the novel method in this trial. Conventional liposuction techniques are used from another site on the patients body to harvest their fat cells.

Publications & conference data

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

1. State of Research on Tissue Engineering with 3D Printing for Breast Reconstruction.
   De Sario Velasquez GD, Tanas Y, Taraballi F, Herzog T, et al · · 2025 · cited 1× · PMID 41095816 · DOI 10.3390/jcm14196737
2. Protocol for single-arm clinical trial evaluating medical grade polycaprolactone breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgery.
   Cheng M, Chapman G, Wagels M, Ung O. · · 2025 · cited 1× · PMID 40306907 · DOI 10.1136/bmjopen-2024-088151