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 of intra-articular (IA) injection of growth hormone (HGH) and platelet-rich plasma (PRP) in adults with knee and ankle arthritis resistant to conventional treatment.
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Integrant Pty Ltd
Lead sponsor
University of Technology, Sydney
Collaborator
Source ClinicalTrials.gov