Clinical trial NCT06907121: Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
Official title: Investigation of Intra-Articular Growth Hormone and Platelet-Rich Plasma on Joint Health in Adults With Knee and Ankle Arthritis Resistant to Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Arthritis Ankle
Arthritis Knee
Lead sponsor: Integrant Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Technology, Sydney
First posted: 2025-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be 2 groups, one with knee arthritis and one with ankle arthritis
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 HGH used will be approved by ethics and comes from a reputable chinese manufacturer called GenSci. The PRP Tubes are supplied by Integrant being a TGA approved device.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ankle mobility and functionality test with AOFAS scale
timeFrame: Baseline, 3-months after final injection, 6-months after final injection
measure: Knee mobility and functionality test with AKS scale
timeFrame: Baseline, 3-months after final injection, 6-months after final injection
Secondary outcomes:
measure: MRI Imaging of the affected arthritic joint
timeFrame: Baseline, 6-months after final injection
measure: Blood test for hormone
timeFrame: Baseline, 2 hours after each injection
Other outcomes:
Locations:
city: Potts Point
country: Australia
facility: Dr Gordon Slater: Orthopaedic Surgeon
state: New South Wales
Study officials:
affiliation: Integrant Pty Ltd
name: Gordon L Slater, Professor
role: PRINCIPAL_INVESTIGATOR
References: