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Preclinical 3-D Printed Breast Tissue Implant Study Begins

3-D printed breast implant

3-D bio-printed regenerative breast implant (Valerie Arad, CollPlant Ltd)

29 June 2022. A study is underway testing 3-D printed regenerative breast tissue models, derived from genetically engineered plant cells, implanted in pigs. The research is conducted by CollPlant Biotechnologies Ltd. in Rehovot, Israel, developer of bio-printed synthetic collagen for aesthetic and reconstructive tissue.

CollPlant says its rhCollagen, short for recombinant human collagen is designed to overcome shortcomings of artificial collagen made from animal, human, or cadaver tissue. These other forms of artificial collagen, says the company, are made from skin, muscles, and bones and run the risk of immune responses in humans, and do not perform as well as natural tissue. CollPlant cites data from the Food and Drug Administration showing some 350,000 reports of adverse effects from breast implants in the U.S. between 2009 and 2019, including autoimmune reactions and lymphoma cases.

CollPlant says rhCollagen is derived from tobacco plants, genetically engineered with five human genes added. The company says its process returns a pristine form of collagen that acts like natural human collagen, without inducing an immune reaction. Tobacco is a well-studied, fast-growing plant often used as a model species in labs. The rhCollagen is formulated into bio-inks for three-dimensional printing in a variety of cell and tissue types.

Integrate with host tissue and promote regeneration

In Dec. 2021, a team from CollPlant described its rhCollagen process and discussed its use as a dermal filler and with reconstructive breast surgery in the journal Plastic and Reconstructive Surgery. Two months earlier, Science & Enterprise reported on a collaboration between CollPlant and Technion – Israel Institute of Technology that produced 3-D printed tissue flaps for lab rats that include blood vessels.

The company’s new project is producing 3-D printed breast tissue models, reduced in size, for implanting in pigs. CollPlant says its bio-printed breast tissue is designed to integrate with host tissue and promote regeneration of new tissue in the recipient, while the original implant degrades over time. The implants, says the company, are customized to withstand physiological loads for the recipient. CollPlant also says it uses computational modeling techniques to design the size and physical properties of implants, and generate precise content of materials to conform with the biological environment of the recipient.

The study with pigs is expected to take six months. CollPlant says the research team will evaluate the implants’ ability to regenerate new adipose or fat tissue in the animals, as well as integration with host tissue, generation of blood vessels, degradation of the implant, and responses or reactions by recipients. The company also plans to use the experience to further develop its surgical procedures, and gain insights for later development of full-size implants.

“We believe that our regenerative breast implants,” says CollPlant CEO Yehiel Tal in a company statement, “will address safety challenges associated with silicone implants while also providing a more natural looking and feeling aesthetic result. Immediately following the conclusion of this study, we are planning to launch a second study with human size implants that mimic commercial products. These studies will advance us to the significant stage of human clinical trials.”

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