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

Integrant Pty Ltd

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Arthritis Knee; Arthritis Ankle

Treatments: Drug: Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06907121

INT-2025-02-12

Details and patient eligibility

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Treatment of Ankle Arthritis

Experimental group

Description:

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.

Treatment:

Drug: Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma

Treatment of Knee Arthritis

Experimental group

Description:

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.

Treatment:

Drug: Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma