None listed
Conditions
Brief summary
The objectives of treatment of symptomatic rotator cuff disease are to relieve pain and restore movement and function of the shoulder. Conservative treatments include rest, NSAIDs, glucocorticoid injections and physical therapy. While specific exercise therapy may be beneficial, most of these treatments often only temporarily relieve the patients’ symptoms, and do not address the underlying tendon pathology. A combination of an increased understanding of pathological processes involved in tendinopathy as well as the success of other autologous therapies for tissue repair has highlighted the potential for tendon repair by delivery of tenocytes to the site of injury. Tendon-derived cells, including tendon progenitor cells (TPCs), possess the potential for tendon regeneration as they have the capacity for collagen synthesis, proliferate rapidly and are self-renewable. The efficacy of tenocyte implantation for stimulation of tendon repair has been verified in a number of in vitro and animal studies. Animal studies have revealed that implantation of in vitro expanded autologous tenocytes improved the tendon structure and facilitated the healing process in both an acute tendon tear model and a chronic degenerative tendon disease model . Based on these studies, it was proposed that restoration of functional cells capable of synthesizing extracellular matrix and repairing the damaged tissue within the tendon may be an effective therapeutic strategy for tendon repair. This method is the basis of the Ortho-ATI (Trademark) tenocyte therapy product developed by Orthocell. Imaging studies of rotator cuff tear indicate that injury to the supraspinatus tendon is most likely to be the cause of rotator cuff disease. The majority of supraspinatus tendon tears occur within a zone close to the tendon insertion. This is most likely due to lack of vascularity within that portion of tendon, and/or increased tensile loading. Furthermore, concealed lesions within the substance of the tendon (interstitial or intrasubstance tears) account for approximately one third of rotator cuff tears detected at the tendon insertion. These lesions present an unmet area of clinical need, as they are not suitable for surgical correction, should non-surgical treatments fail. Ortho-ATI (Trademark) is a minimally-invasive treatment which, unlike other conservative treatments, directly addresses the underlying pathology of rotator cuff tendinopathy and tear. This randomised, controlled study has been designed to investigate the feasibility of Ortho-ATI (Trademark) as an alternative treatment for patients with partial, intrasubstance rotator cuff tear and tendinopathy.
Interventions
Interventional
Ortho-ATI (Trademark) is a Class 3 Biological autologous tenocyte implantation (ATI) product manufactured in Australia by Orthocell since 2008. Ortho-ATI is intended for homologous and autologous use only. The product comprises of autologous tendon cells taken from healthy patella tendons of patients. These cells are proliferated using an in vitro cell culture technique and reconstituted with patient's own serum for local injection.
Patellar Tendon Biopsy
Autologous tenocytes will
Interventional Ortho-ATI (Trademark) is a Class 3 Biological autologous tenocyte implantation (ATI) product manufactured in Australia by Orthocell since 2008. Ortho-ATI is intended for homologous and autologous use only. The product comprises of autologous tendon cells taken from healthy patella tendons of patients. These cells are proliferated using an in vitro cell culture technique and reconstituted with patient's own serum for local injection. Patellar Tendon Biopsy Autologous tenocytes will be harvested from participants via patellar tendon biopsy under local anaesthetic by an orthopaedic surgeon who has received specific training on ATI biopsy and implantation . A 3 x 1mm strip of tendon will be harvested from the superficial surface of the patella tendon using a 14 gauge biopsy needle. Participants will be advised to avoid over use or excessive repetitive motions for 1-2 days. Tenocyte Injection Approximately 4 weeks post-biopsy, up to 2ml of autologous human tenocytes (2-5 x 106 cells/ml) suspended in 10% autologous human serum will be injected using an 18-gauge needle. The injection will be performed under ultrasound guidance into the tendinopathy/tear site at the affected tendon. Participants will be advised to rest for two days and restrict activity to light household/office duties for four weeks. The Ortho-ATI (trademark) treatment and Celestone comparator are both TGA approved products. and will be administered in a single dose.
Sponsors
Orthocell Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria: -Male or female between 30 and 65 years of age -Duration of symptoms > 6 months -Partial thickness, intra-substance supraspinatus tear without communication to the bursal or articular surface, that in the Investigator’s opinion, is of a sufficient size for treatment with Ortho-ATI (trademark), and is verified by MRI -Previously received one or more corticosteroid injections into the affected joint -Able to comply with the requirements of the protocol -Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP
Exclusion criteria
Corticosteroid or other treatment injection into the affected joint within 3 months of the first study visit. -Previous shoulder surgery or fracture on the affected side - Significant pathology of affected shoulder, that could, in the opinion of the Investigator, potentially compromise the outcome of treatment - Bilateral shoulder pathology Active infection or systemic pathology including inflammatory joint disease, HIV, uncontrolled or poorly controlled diabetes, hepatitis or neoplastic disorders Neuromuscular disease of the affected arm -Metabolic bone disorder which could impair bone or soft tissue function -Professional athlete -Workers compensation or other compensation case -Known hypersensitivity to the study treatment or its excipients or known relevant medication allergy -Contraindicated to MRI -Female participant who is pregnant or lactating -Known substance abuse -Participation in another study with an investigational product within 3 months of the first planned study visit -Concurrent medical condition which precludes the administration of study treatment or comparator -Other clinically significant disease (including psychological disorders), medical condition or other factor that would, in the opinion of the Investigator, compromise the safety of the participant or the outcome of the study
Outcome results
None listed