Where does the technology stand now?
Research funding for 3D printing of skin cells onto burn wounds ended with the pig studies and AFIRM 1. It’s not because the technology didn’t work. It did, Dr. Jackson says. But the reviewers had to pick and choose which projects would get further funding, according to Dr. Jackson.
The Department of Defense, National Institutes of Health and Armed Forces Regenerative Medicine Institute have since earmarked $75 million for AFIRM 2, which is beginning the fourth of five years. The research in AFIRM 2 is looking at restoring function to traumatized limbs, reconstructing facial and skull injuries with tissue regeneration; treatments to prevent rejection of face, hand and other transplants; genital and urinary organ and lower abdomen reconstruction; as well as skin regeneration for burn injuries.
Wound healing studies continue in AFIRM 2, but in different areas. For example, Wake Forest researchers are looking at whether an amniotic membrane preparation is effective at healing wounds. The research funding for AFIRM 2 was for five years. There are two years left, according to Dr. Jackson.
As for skin bio-printing with the 3D printer, Dr. Jackson says his colleagues at Wake Forest are compiling the animal data in order to submit an application for an investigational new drug (IND), for a clinical trial.
“The application to the FDA is very complicated. We’re using two cells types, so that would go in as a biologic to the FDA. Then, we’re using a skin bio printer that is sitting over a patient and applying the cells to the patient. So that is classified as a device. We have to get all of that approved to proceed to a clinical trial,” he says.
The result is that skin bio-printing with this device will not be commercially available anytime soon, but it’s on the horizon, Dr. Jackson says.
Disclosure: Dr. Jackson reports no relevant disclosures, other than he is leading the area of research for AFIRM 2.