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Search / Trial NCT06907121

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

Launched by INTEGRANT PTY LTD · Mar 26, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating whether injections of growth hormone (HGH) and platelet-rich plasma (PRP) can help improve joint health in adults suffering from knee and ankle arthritis that hasn't responded to regular treatments. The study is being led by Professor Gordon Slater and aims to see if these injections can promote healing and regeneration of cartilage in the affected joints. They plan to enroll 60 participants who will receive three injections over a span of a few weeks.

To be eligible for this trial, participants must be between the ages of 65 and 75 and have arthritis in their knees or ankles that has not improved with traditional treatments. They should also have a significant cartilage injury confirmed by an MRI or X-ray. Participants will need to attend follow-up visits for assessments at 3 and 6 months after their treatment. It's important to note that certain conditions, like active infections or cancers, may disqualify someone from joining the study. Overall, this trial aims to provide a new treatment option for patients with persistent arthritis, possibly avoiding the need for surgery.

Gender

ALL

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.

About Integrant Pty Ltd

Integrant Pty Ltd is a biopharmaceutical company dedicated to advancing innovative therapies through rigorous clinical research and development. With a focus on enhancing patient outcomes, Integrant specializes in the design and execution of clinical trials across various therapeutic areas. The company is committed to upholding the highest standards of scientific integrity and regulatory compliance, leveraging cutting-edge technology and a team of experienced professionals to drive efficient and effective trial management. By fostering collaborative partnerships with healthcare providers and research institutions, Integrant aims to accelerate the delivery of breakthrough treatments to market, ultimately improving lives and transforming healthcare.

Locations

Potts Point, New South Wales, Australia

Patients applied

0 patients applied

Trial Officials

Gordon L Slater, Professor

Principal Investigator

Integrant Pty Ltd

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported