Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health

This clinical study will evaluate the efficacy and safety of intra-articular (IA) recombinant human growth hormone (rhGH; somatropin) combined with platelet-rich plasma (PRP) in adults with treatment-resistant knee and ankle osteoarthritis. The study, sponsored by Integrant Pty Ltd and Prof. Reza Salleh as the primary investigator, is a Phase IIb, double-blind, randomised, placebo-controlled trial designed to determine whether IA rhGH and PRP can improve joint function and symptoms compared with saline placebo. The study will recruit 192 participants, with separate knee and ankle cohorts. Participants will receive five IA injections, administered 7-16 days apart. The active treatment consists of 15 IU somatropin combined with 10 mL PRP per injection, while the control group will receive volume-matched sterile saline. Outcomes will be assessed using WOMAC for knee participants and FAOS for ankle participants, with the primary endpoint assessed at 6 months after the final injection. Treatment success is defined as a ≥30% improvement from baseline in the relevant joint-specific score. The study hypothesises that intra-articular rhGH combined with PRP will improve pain, symptoms and physical function in patients with treatment-resistant arthritis compared with saline placebo, potentially providing a non-surgical treatment option for these patients.

Inclusion criteria include: * Ankle/Knee arthritis resistant to treatment in GP clinic setting. * Radiographically confirmed cartilage injury with Kellgren-Lawrence grade 1-3 can be shown on MRI scan or weight bearing X-Ray within 6 months of study application. * Able to give informed consent to participate in a clinical trial. * Able to commit to attending a clinic for follow up. Exclusion Criteria: Known contraindications for ARTG registered somatropin from various manufacturers (Humatrope, Genotropin) have been used to guide the development of somatropin-related exclusion criteria. Exclusion criteria include: * A known hypersensitivity to any of the components of the product. * Cancer diagnosis or suspicion. * Resected or active tumour. * Skeletally immature (\ 5 degrees. * Severe osteoarthritis (Kellgren-Lawrence grade 4 on baseline imaging), including bone-on-bone joints with no detectable cartilage. * Known hypersensitivity to citrate or somatropin. * Unable to give informed consent. * Unable to commit to attend clinic for all follow ups.