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Living Cell 3D-Printed Skin System CellPrint Receives FDA Approval: Autologous Skin Regeneration Time Reduced by 80% for Severe Burn Patients

American regenerative medicine company Cellink's CellPrint system uses patients' own stem cells to directly 3D-print multi-layered skin tissue, reducing skin regeneration time for severe burn patients from months to just two weeks.

Living Cell 3D-Printed Skin System CellPrint Receives FDA Approval: Autologous Skin Regeneration Time Reduced by 80% for Severe Burn Patients

On January 10, 2031, American regenerative medicine company Cellink (now part of BICO) announced that its CellPrint living cell 3D-printed skin system has received FDA approval. The system can extract stem cells from a small autologous skin biopsy, expand them in vitro, and then use 3D printing technology to construct complete skin tissue layer by layer, including the epidermis, dermis, and basement membrane.

CellPrint's core technology is a bio-ink called BioVive, composed of the patient's own cells mixed with a degradable hydrogel scaffold. The print head deposits the bio-ink layer by layer with 10-micron precision, using blue-light crosslinking technology to cure the tissue structure in real time during printing.

"In traditional severe burn treatment, patients must undergo multiple painful skin graft surgeries, and donor skin sites are limited," explained Jeremy Goverman, director of the Burn Center at Massachusetts General Hospital. "CellPrint can grow full-body coverage skin from a small biopsy tissue in just two weeks — this is a fundamental breakthrough."

In clinical trials involving 120 severe burn patients, CellPrint-printed skin tissue achieved a survival rate of over 90% within 4 weeks after transplantation, with a rejection rate of only 3% — far below the 35% seen with traditional allogeneic skin grafts.

However, CellPrint can currently only print skin tissue up to 2 millimeters thick and cannot yet reconstruct complete skin with appendage structures such as hair follicles and sweat glands. Cellink says it is developing next-generation printing technology that includes skin appendages.

The system costs approximately $50 per square centimeter per treatment, with typical treatment costs for severe burn patients ranging from $100,000 to $200,000. Cellink is currently negotiating coverage plans with healthcare agencies in various countries.