Imagine using your own cells to repair damaged knee cartilage. That is
the goal of research being done by J. Melvin Deese, M.D.,
board-certified
orthopaedic
surgeon at Summit Sports Medicine & Orthopaedic Surgery, a strategic
affiliate of Southeast Georgia Health System. Deese is one of the few
surgeons selected to investigate the NOVOCART® 3D cellular implant
system. He was chosen as principal investigator for his previous experience
with cartilage transplants and because the Health System has a dedicated
research department. Denny A. Carter, M.D. and Beau Sasser, M.D. were
chosen as
subinvestigators
.
The NOVOCART system is under study for repair of articular cartilage defects
in the knee as well as osteochondral lesions, which occur in the cartilage
and supporting bone. The lesions are usually caused by blood loss related
to trauma, but in some cases their cause is unknown. Left untreated, they
lead to degenerative arthritis.
While NOVOCART 3D has been used in Europe since 2003, it has not been
approved by the U.S. Food and Drug Administration (FDA).
Deese will evaluate a procedure using NOVOCART 3D in two separate surgeries.
“In the first surgery, we remove a small amount of knee cartilage,
about the size of a pencil eraser. We then send this cartilage to the
NOVOCART manufacturing facility where it is processed for re-implantation.
The cartilage cells are cleaned and grown in a sterile container, then
placed onto a 3-dimensional sponge-like scaffold,” Deese explains.
These cells are called autologous chondrocytes. “Autologous meaning
from yourself; chondrocytes meaning cartilage cells,” Deese says.
During a second surgery about three weeks later, Deese will clean the
damaged area of the knee cartilage and implant the sponge-like scaffold
into this space. Previous methods used a flat, two-dimensional sheet of
cartilage cells. In contrast, the NOVOCART three-dimensional scaffold
actually fills the cartilage defect.
The trial will compare the three-dimensional procedure with microfracture,
the current treatment for cartilage defects. In microfracture, a surgeon
drills small holes into the defect to stimulate fibrocartilage growth.
“Unfortunately, this fibrocartilage is not the same as true articular
cartilage,” Deese says, adding, “Our primary objective with
this study is to demonstrate the superior efficacy of NOVOCART 3D, compared
to microfracture. We will then seek FDA approval.”
The trial will last for five years after the last participant is enrolled.
“We’re recruiting subjects and expect 233 to participate,”
Deese says. While NOVOCART 3D is still experimental, it is promising for
people with damaged cartilage. “Once a procedure is proven effective
and approved for use in one part of the body, other joints are studied
and become approved for its use. The chances for that greatly improve
after a successful trial and FDA approval,” Deese explains.
To inquire about participating in the NOVOCART 3D trial, call Gwen Gratto-Cox,
clinical research coordinator, at Summit Sports Medicine & Orthopaedic
Surgery, 912-466-7379.