Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIntegrant Pty Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
A known hypersensitivity to any of the components of the product.
Cancer diagnosis or suspicion.
Resected or active tumour.
Skeletally immature (<18 years of age or no radiographic evidence of closure of epiphyses).
Trial design
Design model
Parallel
Treatments tested in this trial
Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
DrugIntervention 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)
DrugTo 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.
Treatment groups
192 Participants
are divided into 4 treatment groupsGroup A: Treatment of Ankle ArthritisActive comparator 1 intervention
Group B: Treatment of Knee ArthritisActive comparator 1 intervention
Group C: Placebo Saline Control Arm for KneePlacebo comparator 1 intervention
Group D: Placebo Saline Control Arm for AnklePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ankle mobility and functionality test with FAOS scale
The Foot and Ankle Outcome Score (FAOS) scale is a widely used outcome measure for ankle and hindfoot conditions, including ankle arthritis, assessing pain, function, and alignment, with scores ranging from 0 to 100, where higher scores indicate better function.
Time frame
Baseline, 6-months after final injection2
Knee mobility and functionality test with WOMAC scale
The Western Ontario and McMaster Universities Arthritic Index (WOMAC) is a validated self-administered health status measure used in assessing pain, stiffness, and function in patients with arthritic knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation, with the score range being 0-68. A higher score indicates worse symptons.
Time frame
Baseline, 6-months after final injectionSecondary outcomes
1
MRI Imaging of the affected arthritic joint
The MRI scans will be evaluated by a radiologist blinded to the treatment allocation to assess changes in: Cartilage volume and thickness, Synovial inflammation (e.g., synovitis), Bone marrow edema, Osteophyte formation, Other structural changes relevant to arthritis progression
Time frame
Baseline, 6-months after final injection2
Blood test for hormone
Blood tests to check for growth hormone within the blood system.
Time frame
Baseline, 2 hours after each injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: