Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), world leader in musculoskeletal health, recently announced the publication of positive results from a pilot study demonstrating the safety and promising effectiveness of the nSTRIDE® autologous protein solution kit. (APS) for the treatment of knee osteoarthritis (OA).
In the trial, known as PROGRESS II, the researchers prepared APS using the Zimmer Biomet nSTRIDE APS kit, which concentrates the anti-inflammatory cytokines and growth factors of a sample of the patient’s blood, for administration through a single intravenous joint injection in the knee joint.
The results, which appeared in The American Journal of Sports Medicine1, show a marked improvement in the percentage change from the beginning in pain scores measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in addition to a comparable safety the saline solution
OA, the most common type of arthritis, is a progressive disease of the joints. Often referred to as wear and tear arthritis, OA occurs when the upper layer of cartilage, the slippery tissue that covers the ends of bones in a joint and helps absorb the impact of movement, breaks down and wears out.
The cartilage bones rub against each other, causing pain, swelling and loss of movement in that joint. Eventually, the joint may lose its regular shape and develop bone spurs around its edges.
Inflammation is a critical factor in the decomposition of pain and cartilage associated with knee osteoarthritis, and research has established that PSA derived from the patient’s whole blood contains a large amount of potent anti-inflammatory and anabolic proteins,
he said. Elizaveta Kon. , MD, associate professor, Humanitas University, Milan, Italy, and principal investigator of the PROGRESS trial.
After almost a decade of preclinical and clinical research on the use of autologous anti-inflammatory cytokines and growth factors to treat osteoarthritis pain,
we are pleased to show that APS, prepared with the nSTRIDE APS kit, can be a promising alternative, safe and viable new treatment for patients living with osteoarthritis of the knee .
The PROGRESS II trial was a prospective, randomized, double-blind, saline-controlled pilot study that recruited 46 patients with unilateral, mild to moderate, symptomatic OA pain in the knee of the four test sites throughout Europe.
Patients were randomized to receive either a single injection of APS prepared by the nSTRIDE APS kit (n = 31), or a single saline injection (n = 15).
The results indicated by the patient and the adverse events were calculated at two weeks, and at one, three, six and 12 months after the injection.
Clinical effectiveness was measured using the Visual Analog Scale (VAS), the WOMAC and the Knee Injury and Osteoarthritis Outcome Scale (KOOS).
X-ray and magnetic resonance imaging (MRI) assessments were performed at the beginning of the study, as well as three and 12 months after treatment.
The first line results showed that patients treated with APS demonstrated:
A 65 percent change in the WOMAC pain score from baseline to 12 months contrasts with a 41 percent change in the saline group (p = 0.02).
A 49 percent improvement in VAS pain scores contrasts with a 13 percent improvement in the saline group (p = 0.06).
There are no serious adverse events related to the procedure or device, and the frequency, severity, and relationship of adverse events comparable to the contrast with the saline group.
The nSTRIDE APS kit is not commercially available in the United States, but is currently marketed in Europe.rope, through the CE mark, and in Japan, where it is sold as the APS kit.
The results of the PROGRESS II study formed the basis of two additional confirmatory trials: the PROGRESS IV trial (NCT02905240), which received approval from the US Food and Drug Administration’s Research Device (IDE) Exemption.
UU (FDA) in July 2016 and is currently enrolling patients, and the PROGRESS V trial (NCT03182374), which is being carried out in Europe to support global reimbursement efforts.
As the world leader in musculoskeletal health care, Zimmer Biomet is committed to addressing the needs of patients throughout the continuum of care, from the management of symptoms such as pain and stiffness with safe intra-articular injections and not invasive systems such as APS and Gel -One®,
to restore joint function and mobility with our extensive portfolio of implant systems to treat advanced orthopedic diseases, said David Nolan, Group Chairman, Biologists, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle, Office-based Technologies and Zimmer Biomet Signature Solutions.
The positive results of the PROGRESS II trial not only reinforce the safety and clinical value of the autologous anti-inflammatory protein solution prepared with the nSTRIDE APS kit, but also lay the foundations to advance our regulatory efforts in the United States and accelerate our commercial adoption and expansion in Europe and Asia-Pacific.