The state of Ohio saw another first in orthopaedic surgery when Dr. David Flanigan of the OSU Wexner Medical Center used a NeoCart tissue implant, made from a patient’s own cells, to treat knee cartilage damage last week.
The surgery, which occurred March 3, is one way to treat knee cartilage damage or injuries, which are common in athletes, but also affect the general populace as wear occurs over time, Flanigan said, adding that he is hopeful this new surgery could provide a different alternative for patients.
Currently, cartilage damage is usually repaired through microfracture surgery, during which a surgeon makes small surgical cuts in the bone near the damaged cartilage. The holes release cells in the bone that build new cartilage to replace the damaged cartilage, according to the U.S. National Library of Medicine website.
“What we strive at OSU sports medicine is really to bring these cutting-edge technologies to our Central Ohio area,” Flanigan said of the NeoCart implant. “We are trying to further our orthopaedic science as well as improve patient outcomes … we just hope that we continue to make improvements in these type of procedures, and the technology to improve patient outcomes.”
The surgery occurred about a month after Dr. Christopher Kaeding, executive director of OSU Sports Medicine, became the first surgeon in the U.S. to implant a new plastic meniscus device, called the “NUsurface” implant, for patients suffering from persistent knee pain because of meniscus injury.
The surgery is part of a process that typically takes six to nine weeks, because of the amount of time it takes to develop the implant, according to Histogenics’ website.
Histogenics is a Massachusetts-based regenerative medicine company that makes the NeoCart implant, according to its website.
Flanigan said the process of using the NeoCart tissue implant is actually composed of two different surgeries.
“The first surgery is really getting the tissue itself for the cartilage. We take a little biopsy of the cartilage and we send that to Histogenics,” he said.
The cartilage is taken from a “non-weight-bearing cartilage surface of the patient’s femur,” according to the Histogenics website.
Using the cartilage, Histogenics creates the NeoCart tissue implant, which is then inserted into the patient’s knee in a secondary surgery, Flanigan said.
Flanigan said he thinks there is a need for new treatments like the NeoCart implant, as they would give the patient the best possible option for their individualized medical needs.
“We need technology like this, for a treatment perspective, something that’s obviously going to provide a durable, long-term solution to some of these cartilage defects,” he said. “So, I think if we find a good solution that’s durable, that can also be cost-effective and easy to use, I think that it can really improve the results of a lot of patients in the long-term.”
Elissa Cote, vice president for marketing and external relations for Histogenics, said the trial is currently in Phase 3, which includes a clinical trial comparing NeoCart to the standard-of-care microfracture. She added that the initial data collection period of the trial is estimated to be completed by the first half of 2017.
Cote said Histogenics is recruiting for the nationwide trial, and is looking for 245 patients. She said enrollment for the trial will be completed by the first half of 2016 and some costs might be covered depending on the patient.
After the trial ends, Cote said Histogenics will evaluate the data and, if the results are positive, will submit the data package to the Food and Drug Administration “for evaluation under a Biologics License Application.”
With approval from the FDA, Cote said Histogenics could “potentially commercialize the product in 2018.”
Flanigan said the NeoCart implant is an example of how new technology can help advance treatment of knee injuries in the future.
“The whole hope with a lot of these newer technologies, like NeoCart, is to provide a more durable tissue that will provide better outcomes for the patients in the long run,” he said.