Beaumont seeks participants for a research study of a cartilage tissue implant for knee injuries

4/7/2014

Beaumont Health System is participating in a research study evaluating an investigational treatment called NeoCart®, a tissue implant made from a patient’s own cells, aimed at repairing certain knee cartilage injuries.

A total of 245 patients will participate in the research of the surgical implant procedure in up to 40 sites across the United States. Approximately 20 patients at Beaumont will participate.  


Beaumont orthopedic surgeon
Dr. Joe Guettler, principal
investigator of the study.

Orthopedic surgeons Joseph Guettler, M.D. and James Bicos, M.D. will be leading the study at Beaumont.  

The research study will look at damage to the knee’s hyaline articular cartilage, the smooth, white tissue that covers the ends of bones where they come together to form joints. Damage to this cartilage may be caused by an injury or repetitive motion. It is a common problem that results in pain and symptoms, such as swelling, locking of the knee and loss of knee function.  Damaged hyaline cartilage has limited capacity to repair or restore itself. Left untreated, the damage may progressively worsen and may lead to chronic conditions such as osteoarthritis. 

To perform the procedure, the surgeon first obtains a sample of healthy cartilage from the patient’s knee. The small sample is treated and placed under special conditions in the laboratory that allow for cell growth. These cells are used to form a hyaline-like cartilage tissue implant that is in the shape of a small disc. The implant is then returned to the surgeon for surgical implantation into the patient’s injury site in the knee. 

“The current standard of care for knee cartilage injuries is a cartilage-repair surgical technique called microfracture which works by creating tiny fractures in the underlying bone. This procedure is thought to create new cartilage-building cells from a so-called super-clot,” explains Dr. Guettler, principal investigator of the study.

“The purpose of the study is to evaluate the effectiveness of the tissue implant compared with microfracture. We will evaluate the pain and knee function in both treatment groups,” says Dr. Bicos, the study’s co-investigator.

 “The possibility of implementing a preventive treatment  aimed at undermining the inevitable consequences of degenerative arthritis could be a very significant advancement,” says Dr. Guettler.

Criteria

Patients 18 to 55 years old who have symptoms of knee pain in one knee may be candidates for this study. However, those who have previously failed other treatments or smoke more than one pack of cigarettes per week may not be eligible.

Patients accepted into the study will have a random chance of being treated with the implant versus microfracture. Neither the patient nor the physician may choose the treatment. Patients in each group will have a specific rehabilitation plan and will be evaluated periodically for three years after treatment.

The study sponsor is Histogenics Corp. For more information, visit www.clinicaltrials.gov keyword “NeoCart Phase III” or contact Beaumont Research Nurse Clinician, Lisa Stellon at 248-551-6679 or at lisa.stellon@beaumont.edu.

About Beaumont Orthpedic Services

Beaumont Health System provides a full range of specialized care in the diagnosis, treatment and rehabilitation of all orthopedic injuries and conditions. Beaumont's department of Orthopedic Surgery offers leading-edge treatments and technology including minimally invasive surgery, implants and trauma surgery. Beaumont is Michigan's most experienced orthopedic hospital specializing in surgeries of the back, neck, foot, ankle, hand and upper extremities; hip and knee replacement; scoliosis treatment; tumor surgery; pediatric orthopedics; and sports medicine.  Beaumont Hospital, Royal Oak is Michigan’s top-ranked hospital for orthopedic care by U.S. News & World Report. Find out more at http://orthopedics.beaumont.edu/.