Orthocell Ltd (ASX:OCC) has published a case study focusing on the combination of CelGro® collagen medical device and autologous tenocyte implantation (Ortho-ATI®) for the surgical repair of a large degenerate tear of the gluteal medius tendon.
The case study was published by internationally recognised orthopaedic hip specialist surgeon Dr John M O’Donnell and sports and exercise doctor Professor Jane Fitzpatrick and supports Ortho-ATI® and CelGro® as durable, long term solutions for degenerate, treatment-resistant tendons that can be used on their own or in combination.
This case report was designed to assess the role and effectiveness of CelGro® when combined with Ortho-ATI® to treat chronic degenerative gluteal tendinopathy in a 63-year-old woman.
The patient suffered from chronic right-sided hip pain for over 15 years, which significantly affected her ability to sleep, work and exercise and underwent numerous conservative treatment options (including physiotherapy, load management, platelet-rich plasma and corticosteroid injection therapy) and right hip replacement surgery - all without success.
Managing director Paul Anderson said: “The positive case study is a global first supporting the combination of CelGro® and Ortho-ATI® to provide a durable solution to treat severely torn tendons.
“This is an exciting pipeline application combining our leading products CelGro® Ortho-ATI® and is a ground-breaking approach that continues to place OCC at the forefront of tendon regenerative medicine.”
The case report may be viewed here.
Ortho-ATI® plus CelGro® treatment process and results
The patient underwent open surgery in April 2017, where the gluteus medius was anatomically repaired.
CelGro®, acting as a carrier and scaffold for Ortho-ATI® (patients' own cultured tenocytes) was then sutured over the repaired tendon. Both CelGro® and Ortho-ATI® were manufactured at Orthocell’s TGA licensed facility prior to surgical implantation.
Pain and function improvement was reported by the patient at the 12-week post-implantation review.
At six months post-treatment, and a physiotherapy-led strength-based exercise program, the patient reported that pain had settled and was walking without a limp - she had normal function in the hip at 12 months.
A structural improvement in the tendon was confirmed by repeat MRI.
“Exciting potential of Ortho-ATI®”
Treating physician Dr John O’Donnell said: “Gluteal tendinopathy and tendon tears are a common and debilitating injury that is often difficult to treat, especially in older patients who are less likely to benefit from surgery.
“This case study highlights the exciting potential of Ortho-ATI® in combination with CelGro® as a novel therapy for torn gluteal tendons requiring surgical repair.
“I am delighted by these results providing long-lasting improvements, returning the patient to normal function.”
Orthocell intends to leverage this case report showing CelGro® and Ortho-ATI® results in high-quality tissue repair to further position the medical device and cell therapy as best-in-class regenerative medicine products that can be used on their own or in combination.
Further performance studies are planned to assist in establishing the effectiveness of the combined product.