Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
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.
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.
Study Overview
Status
Conditions
Detailed Description
This clinical study will evaluate the efficacy and safety of intra-articular (IA) administration of recombinant human growth hormone (rhGH; somatropin) in combination with platelet-rich plasma (PRP) in adults with knee and ankle osteoarthritis resistant to conventional treatment. The investigational product will consist of 15 IU of somatropin combined with 10 mL of autologous PRP per injection.
The study, sponsored by Integrant Pty Ltd, will be conducted as a Phase IIb, multi-centre, double-blind, randomised, placebo-controlled, parallel-group superiority trial. Participants will be randomised 1:1 to receive either rhGH + PRP or volume-matched saline placebo. The primary site is St John of God Subiaco, with RegenU Clinics in Potts Point as the secondary site.
The study will recruit 192 participants, comprising 96 participants in the knee cohort and 96 participants in the ankle cohort. Within each cohort, 48 participants will receive rhGH + PRP and 48 will receive saline placebo. Participants will receive five IA injections into the affected knee or ankle joint, administered 7-16 days apart, over approximately 4-9 weeks. Injections will be performed under ultrasound guidance. Following each injection, participants in both treatment groups will undergo 20 minutes of non-invasive joint distraction.
Participants randomised to the placebo group will receive sterile normal saline (0.9% NaCl), volume-matched at approximately 10-12 mL per injection. To maintain the double-blind design, blood will also be collected from placebo participants for PRP preparation, but the blood will be discarded and the participant will receive saline only. Active and placebo preparations will be administered using identical opaque syringes and study-code labelling, with preparation performed by an independent unblinded clinical staff member. Participants, treating clinicians and outcome assessors will remain blinded to treatment allocation.
The inclusion criteria include ankle or knee arthritis resistant to treatment in the GP clinic setting; radiographically confirmed cartilage injury with Kellgren-Lawrence grade 0-3 demonstrated on MRI or weight-bearing X-ray within six months of study application; ability to provide informed consent; and ability to attend required follow-up visits. Exclusion criteria include known hypersensitivity to any component of the product; cancer diagnosis or suspicion; active or resected tumour; skeletal immaturity; pregnancy or breastfeeding; active infection at the injection site; open soft-tissue injury; specified metabolic disorders affecting the skeleton; age over 70 years; unstable or malaligned joint greater than 5 degrees; severe osteoarthritis classified as Kellgren-Lawrence grade 4, including bone-on-bone joints with no detectable cartilage; hypersensitivity to citrate or somatropin; inability to provide informed consent; or inability to attend required follow-up visits.
The primary endpoint is the proportion of participants achieving treatment success at six months, defined as a ≥30% improvement from baseline in the joint-specific functional score compared with the control group. FAOS will be used for participants with ankle osteoarthritis and WOMAC for participants with knee osteoarthritis. Secondary assessments include clinical assessment of symptoms and function at three months and six months, as well as repeat MRI and X-ray imaging at six months.
Blood samples will be collected for HGH measurement, including samples taken before and two hours after each injection following the baseline assessment. These measurements will be used to assess systemic exposure and the local versus systemic pharmacodynamic effects of the intervention. Safety will also be monitored through adverse-event assessment, laboratory testing and ongoing independent medical review.
The study hypothesises that intra-articular rhGH combined with PRP, administered within the standardised joint-distraction protocol, will improve clinical outcomes in patients with treatment-resistant knee or ankle osteoarthritis compared with saline placebo. The study is intended to provide preliminary evidence of efficacy and safety and inform the design of a subsequent Phase III clinical trial.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Zadane F Bachmid
- Phone Number: +61 426 672 977
- Email: zadane@integrant.com.au
Study Locations
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New South Wales
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Potts Point, New South Wales, Australia, 2011
- Integrant Office
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Contact:
- Zadane F Bachmid
- Phone Number: +61 7232 1156
- Email: zadane@integrant.com.au
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Principal Investigator:
- Joseph Gracé, Doctor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 (<18 years of age or no radiographic evidence of closure of epiphyses).
- Pregnancy/breastfeeding (participants of childbearing potential need negative pregnancy test in prior screening and agreed upon method of contraception throughout duration of study)
- Active infection at the injection site.
- Open soft tissue injury.
- Metabolic disorders known to adversely affect the skeleton (e.g. renal osteodystrophy or hypercalcemia), other than primary osteoporosis or diabetes.
- Over 70 years of age.
- Unstable joint or maligned joint > 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment of Ankle Arthritis
Injection of 15 iu of Somatropin and 10ml of Platelet-Rich Plasma conjunct via intra-articular injection of the arthritic ankle.
This will be administered with a 7-16 day buffer period between each injection.
There will be five total injections for the study.
|
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.
|
|
Active Comparator: Treatment of Knee Arthritis
Injection of 15 iu of Somatropin and 10ml of Platelet-Rich Plasma conjunct via intra-articular injection of the arthritic knee.
This will be administered with a 7-16 day buffer period between each injection.
There will be five total injections for the study.
|
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.
|
|
Placebo Comparator: Placebo Saline Control Arm for Knee
Injection of sterile saline, volume matched to the active treatment (10ml-12ml) intra-articular injection of the arthritic knee.
This will be administered with a 7-16 day buffer period between each injection.
There will be five total injections for the study.
|
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.
|
|
Placebo Comparator: Placebo Saline Control Arm for Ankle
Injection of sterile saline, volume matched to the active treatment (10ml-12ml) intra-articular injection of the arthritic ankle.
This will be administered with a 7-16 day buffer period between each injection.
There will be five total injections for the study.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ankle mobility and functionality test with FAOS scale
Time Frame: Baseline, 6-months after final injection
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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.
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Baseline, 6-months after final injection
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Knee mobility and functionality test with WOMAC scale
Time Frame: Baseline, 6-months after final injection
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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.
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Baseline, 6-months after final injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MRI Imaging of the affected arthritic joint
Time Frame: Baseline, 6-months after final injection
|
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
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Baseline, 6-months after final injection
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Blood test for hormone
Time Frame: Baseline, 2 hours after each injection
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Blood tests to check for growth hormone within the blood system.
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Baseline, 2 hours after each injection
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Reza Salleh, Associate Professor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT-2025-02-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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