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Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
Sponsor: Integrant Pty Ltd
Summary
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.
Official title: A Double-Blind Randomised, Saline-Controlled Investigation of Intra-Articular Growth Hormone and Platelet-Rich Plasma on Joint Health in Adults With Knee and Ankle Arthritis Resistant to Treatment.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
192
Start Date
2026-11
Completion Date
2027-12
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
Intervention will be an intra-articular injection of 15 units of HGH and 10 mL PRP conjunct. Five total injections/placements of HGH spaced 7 to 16 days apart on either the effected ankle or knee joint guided by ultrasound.
Saline (NaCl 0,9 %) (placebo)
To enable a double-blind 1:1 randomised controlled design, the control arm will receive intra-articular sterile saline (0.9% sodium chloride) as placebo. Normal saline is the standard placebo used in many intra-articular injection trials for osteoarthritis. It can be easily matched for volume (\~10-12 mL) and appearance (using identical opaque syringes and study codes) to maintain effective blinding for participants, injecting physicians, and outcome assessors.
Locations (1)
Integrant Office
Potts Point, New South Wales, Australia