Andrews Institute to study stem cells' impact on knee
Joseph Baucum , jbaucum@pnj.com Published 4:06 p.m. CT April 16, 2017
http://www.pnj.com/story/money/busin...-fda/99978484/

Andrews Institute is conducting new stem cell research that could impact the FDA approval of certain treatments. Joseph Baucum\jbaucum@pnj.com

By the time most reach age 55, Adam Anz estimates as much as 30 percent of the population will incur some form of knee degeneration, a problem that equals pain and in many cases, surgery.

“It’s a problem that we’re all going to face at some point in our lives,” said Anz, orthopaedic surgeon at Andrews Institute for Orthopaedics & Sports Medicine.

But in May, a new study will begin at Andrews Institute in Gulf Breeze that could play a game-changing role in evolving the range of medicine available for treating knee injuries. In the process, the research may also help drive down patients’ costs.

Anz will help spearhead a study next month into increasing the amount of stem cells doctors are able to harvest from bone marrow transplants with the goal of utilizing those cells to regrow cartilage in knees. Cartilage, a tough and flexible material, is essential to the knee, because it acts as a cushion between the bones in the joint. Damaged cartilage can often necessitate knee replacement.

In the study, Anz said researchers will attempt to increase the amount of stem cells in participants’ bone marrow, which would then empty from the marrow into their bloodstream. Researchers would collect the blood, separate the stem cells from it and inject the cells into patients’ knees. Doctors would then monitor if the marrow cells transform into cartilage cells and spark regeneration.

“It’s about determining how can we obtain those cells in efficient quantities and put those cells in the right place at the right time to help with healing patients’ injuries,” Anz said.

Because the Food & Drug Administration has not approved the vast majority of stem cell-based remedies, not all treatments involving the cells are available for patients, including the cartilage procedure. For the treatments that are offered, health insurance providers do not cover them without the FDA’s consent. Patients who choose to undergo them must pay out-of-pocket prices.

The study at Andrews Institute could push a stem cell cartilage treatment closer to FDA approval and by extension, availability and affordability. The research is an official FDA study. It is led by Khay Yong Saw, a Malaysian physician who has already demonstrated conceptual proof of the treatment in an animal study in 2006. He completed a randomized control trial in 2012. This study is the next step in proving the safety and efficacy of the procedure to gain federal endorsement.

Anz, optimistic about the study’s potential, emphasized more research must be conducted into the effectiveness of stem cell treatments – those already available and those still in the testing phase.

“It’s important to be excited about technologies, but it’s also important to be honest with the patients that more must be done to show these treatments are effective,” said Anz, who estimated the cartilage study to require two years for participant enrollment and another two years before researchers can observe outcomes.

But some who have undergone stem cell treatments advocate for the procedures’ federal approval. Jody Falvey, a retired Pensacola resident, had a stem cell procedure conducted at Andrews Institute on her knee in the fall of 2012.

Falvey, 67, tore the medial and lateral meniscus in her knee during a family visit to South Florida while brewing coffee in the morning. The sensation, she said, felt like a knife slicing through her joint.

Following a consultation with Anz, who described an available stem cell treatment known as bone marrow aspirate concentrate, Falvey chose to have the procedure done. The treatment utilized cells from her own body to repair the knee. The process, from procedure to recovery, spanned about two years.

Falvey said her knee does not feel like it ever underwent surgery. The fact that it helped prevent her from having to undergo a knee replacement made the operation even better.

“I did not want metal in my body,” she said. “This was just one of the greatest alternatives I had heard of. I would do it again in a heartbeat.”