drugset / Trial / NCT06907121

Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health

NCT06907121

Phase 2/3 Not yet recruiting 60 enrolled Integrant Pty Ltd University of Technology, Sydney · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-06-01
Primary completion
2027-12-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Platelet Rich Plasma Other / unclassified 10 ml Other
Subject Somatropin Protein / enzyme biologic 10 iu Other

Indications