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

About this trial

Last updated a year ago

Study ID

INT-2025-02-12

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18 to 70 Years

All Sexes

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.