Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
NCT ID: NCT06907121
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2025-06-01
2027-12-01
Brief Summary
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The study, sponsored by Integrant Pty Ltd and led by Prof. Gordon Slater, aims to determine whether IA HGH injections can enhance cartilage regeneration and joint healing.
The study will recruit 60 patients who will receive three IA injections of HGH and PRP spaced 7-16 days of each other.
Outcomes will be assessed using AOFAS and AKS scoring systems at 3- and 6-months post-treatment.
The study hypothesizes that HGH will increase healing of arthritic or injured joints compared to standard treatment, potentially providing a non-surgical alternative for patients with treatment-resistant arthritis.
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Detailed Description
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The study, sponsored by Integrant Pty Ltd and led by Prof. Gordon Slater, aims to determine whether IA HGH injections can enhance cartilage regeneration and joint healing. This study will be completed within Prof Gordon Slater's private clinic in a clean environment.
The study will recruit 60 patients who will receive three IA injections of HGH and PRP over 7-16 days. The inclusion criteria includes: Ankle/Knee arthritis resistant to treatment in GP clinic setting, Significant Ankle/Knee cartilage injury can be shown on MRI scan or weight bearing X-Ray within 6 months of study application, Able to give informed consent to participation in a clinical trial, Able to commit to attending clinic for follow up. The exclusion criteria include: A known hypersensitivity to any of the components of the product, Cancer diagnosis or suspicion, Resected or active tumor, Skeletally immature (\<18 years of age or no radiographic evidence of closure of epiphyses), Pregnancy, 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%, No cartilage detected in the joint (bone on bone in medical imaging), Unable to give informed consent, Unable to commit to attend clinic for follow up.
Outcomes will be assessed using AOFAS and AKS scoring systems at 3- and 6-months post-treatment. A secondary outcome of the study includes having a blood test before each injection intervention and 2 hours after each injection. This is to test for HGH within the blood of the patient.
The study hypothesizes that HGH will increase healing of arthritic or injured joints compared to standard treatment, potentially providing a non-surgical alternative for patients with treatment-resistant arthritis.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment of Ankle Arthritis
Injection of 10 iu of Somatropin and 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 three total injections for the study.
Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
Intervention will be an intra-articular injection of 10 units of HGH and 10 mL PRP conjunct. Three total injections/placements of HGH spaced 7 to 16 days apart on either the effected ankle or knee joint guided by ultrasound.
Treatment of Knee Arthritis
Injection of 10 iu of Somatropin and 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 three total injections for the study.
Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
Intervention will be an intra-articular injection of 10 units of HGH and 10 mL PRP conjunct. Three total injections/placements of HGH spaced 7 to 16 days apart on either the effected ankle or knee joint guided by ultrasound.
Interventions
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Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
Intervention will be an intra-articular injection of 10 units of HGH and 10 mL PRP conjunct. Three total injections/placements of HGH spaced 7 to 16 days apart on either the effected ankle or knee joint guided by ultrasound.
Eligibility Criteria
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Inclusion Criteria
* Significant Ankle/Knee cartilage injury can be shown on MRI scan or weight bearing X-Ray within 6 months of study application.
* Able to give informed consent to participation in a clinical trial.
* Able to commit to attending clinic for follow up.
Exclusion Criteria
* Cancer diagnosis or suspicion.
* Resected or active tumor.
* Skeletally immature (\<18 years of age or no radiographic evidence of closure of epiphyses).
* Pregnancy.
* 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%
* No cartilage detected in the joint (bone on bone in medical imaging)
* Unable to give informed consent.
* Unable to commit to attend clinic for follow up.
18 Years
70 Years
ALL
No
Sponsors
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University of Technology, Sydney
OTHER
Integrant Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Gordon L Slater, Professor
Role: PRINCIPAL_INVESTIGATOR
Integrant Pty Ltd
Locations
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Dr Gordon Slater: Orthopaedic Surgeon
Potts Point, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INT-2025-02-12
Identifier Type: -
Identifier Source: org_study_id
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