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

NCT06907121 | Not Yet Recruiting Phase 2

• 1 other identifier: INT-2025-02-12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis Ankle; Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• Ankle mobility and functionality test with AOFAS scale

  The AOFAS (American Orthopaedic Foot and Ankle Society) scale is a widely used outcome measure for ankle and hindfoot conditions, including ankle arthritis, assessing pain, function, and alignment, with scores ranging from 0 to 100, where higher scores indicate better function.

  Baseline, 3-months after final injection, 6-months after final injection

• Knee mobility and functionality test with AKS scale

  The AKS is a validated instrument used to assess patient outcomes after surgical knee interventions, evaluating both the knee joint itself (Knee Score) and functional ability (Function Score).

  Baseline, 3-months after final injection, 6-months after final injection

Secondary Outcomes (2)

• MRI Imaging of the affected arthritic joint

  Baseline, 6-months after final injection

• Blood test for hormone

  Baseline, 2 hours after each injection

Study Arms (2)

Treatment of Ankle Arthritis

EXPERIMENTAL

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.

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

Treatment of Knee Arthritis

EXPERIMENTAL

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.

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

Interventions

Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma DRUG

Intervention will be an intra-articular injection of 10 units of HGH and 10 mL PRP conjunct. Three total injections/placements of HGH spaced 7 to 16 days apart on either the effected ankle or knee joint guided by ultrasound.

Treatment of Ankle Arthritis; Treatment of Knee Arthritis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrant Pty Ltd: lead
• University of Technology, Sydney: collaborator

Study Sites (1)

Dr Gordon Slater: Orthopaedic Surgeon

Potts Point, New South Wales, 2011, Australia

Location

Study Officials

• Gordon L Slater, Professor

  Integrant Pty Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gordon L Slater, Prof

CONTACT

+61 418 721 380; gordonjakll@gmail.com

Zadane F Bachmid

CONTACT

+61 426 672 977; zadane@integrant.com.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Everyone receives the same intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be 2 groups, one with knee arthritis and one with ankle arthritis

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

AU (1)