Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
NCT06907121 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-04-02
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
Interventions
- DRUG
-
Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
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.
Sponsors & Collaborators
-
University of Technology, Sydney
collaborator OTHER -
Integrant Pty Ltd
lead INDUSTRY
Principal Investigators
-
Gordon L Slater, Professor · Integrant Pty Ltd
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2027-12-01
- Completion
- 2027-12-01
Countries
- Australia
Study Locations
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