I gave you the trial details above. W3Booster, I am not a free research analyst and only commented before because you incorrectly suggested J&J's involvement might even be a HC myth - I will never understand why people put out false rumours about stocks they own.
I've published plenty of details on the trial in past posts on here, again often in response to lazy false presumptions. The information is there in the company announcements and reports, but its hard work - welcome to fundamental investment analysis. J&J basically sponsors and sets the trial parameters with OCC. OCC staff do not run the trial, Physicians do [Clinical Professor Allan Wang (former President of the Australian Elbow and Shoulder Society), Dr Jeff Hughes (current President of the Australian Elbow and Shoulder Society), Dr Jane Fitzpatrick, and Professor Ming Hao Zheng (University of Western Australia)] do, but ultimately obviously consult and report to OCC and J&J.
Its not hard to find this stuff with a bit of effort. Here is the original extract from the ANZCTR (trial registry):
Study Type:
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.
Treatment: OtherComparator / control treatment Participants will receive a single, ultrasound guided injection of 1mL Celestone (Registered Trademark) Chronodose (betamethasone sodium phosphate 3.9mg/betamethasone acetate 3mg) combined with local anaesthetic into the subacromial space.
OUtcomes:
Primary outcome Measurement of tendon healing by MRI assessment by a radiologist Timepoint 6 and 12 months.
Secondary outcome Shoulder Pain assessed by VAS pain score Timepoint 3,6 and 12 months post-treatment
Secondary outcome Symptoms assessed by OSS, CMS and ASES (composite outcome) Timepoint 3,6 and 12 months post-treatment
Eligibility Key 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
Key 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 pathologyActive infection or systemic pathology including inflammatory joint disease, HIV, uncontrolled or poorly controlled diabetes, hepatitis or neoplastic disordersNeuromuscular 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
etc, etc, etc....
You can get why the study took so long. A lot of exclusion criteria. A lot of patients rejected. The shoulder is a very complicated joint and no one rotator cuff presentation alike, hence the complicated inclusion/exclusion criteria - patients might also have a slap lesion to the glenoid labrum, a rupture of the acromioclavicular ligament, tear of the coracoclavicular ligament, frozen shoulder, impingement, as well, which are obvioulsy not specific tendon issues and going to mar the result.
OCC Price at posting:
46.0¢ Sentiment: Buy Disclosure: Held
(20min delay)