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: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will evaluate the efficacy and safety of intra-articular (IA) recombinant human growth hormone (rhGH; somatropin) combined with platelet-rich plasma (PRP) in adults with treatment-resistant knee and ankle osteoarthritis. The study, sponsored by Integrant Pty Ltd and Prof. Reza Salleh as the primary investigator, is a Phase IIb, double-blind, randomised, placebo-controlled trial designed to determine whether IA rhGH and PRP can improve joint function and symptoms compared with saline placebo. The study will recruit 192 participants, with separate knee and ankle cohorts. Participants will receive five IA injections, administered 7-16 days apart. The active treatment consists of 15 IU somatropin combined with 10 mL PRP per injection, while the control group will receive volume-matched sterile saline. Outcomes will be assessed using WOMAC for knee participants and FAOS for ankle participants, with the primary endpoint assessed at 6 months after the final injection. Treatment success is defined as a ≥30% improvement from baseline in the relevant joint-specific score. The study hypothesises that intra-articular rhGH combined with PRP will improve pain, symptoms and physical function in patients with treatment-resistant arthritis compared with saline placebo, potentially providing a non-surgical treatment option for these patients.

Conditions

Arthritis Knee; Arthritis Ankle

Outcome Measures

Primary Outcomes (2)

• Ankle mobility and functionality test with FAOS scale

  The Foot and Ankle Outcome Score (FAOS) 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, 6-months after final injection

• Knee mobility and functionality test with WOMAC scale

  The Western Ontario and McMaster Universities Arthritic Index (WOMAC) is a validated self-administered health status measure used in assessing pain, stiffness, and function in patients with arthritic knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation, with the score range being 0-68. A higher score indicates worse symptons.

  Baseline, 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 (4)

Treatment of Ankle Arthritis

ACTIVE COMPARATOR

Injection of 15 iu of Somatropin and 10ml of 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 five total injections for the study.

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

Treatment of Knee Arthritis

ACTIVE COMPARATOR

Injection of 15 iu of Somatropin and 10ml of 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 five total injections for the study.

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

Placebo Saline Control Arm for Knee

PLACEBO COMPARATOR

Injection of sterile saline, volume matched to the active treatment (10ml-12ml) intra-articular injection of the arthritic knee. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study.

Drug: Saline (NaCl 0,9 %) (placebo)

Placebo Saline Control Arm for Ankle

PLACEBO COMPARATOR

Injection of sterile saline, volume matched to the active treatment (10ml-12ml) intra-articular injection of the arthritic ankle. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study.

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Saline (NaCl 0,9 %) (placebo) DRUG

To enable a double-blind 1:1 randomised controlled design, the control arm will receive intra-articular sterile saline (0.9% sodium chloride) as placebo. Normal saline is the standard placebo used in many intra-articular injection trials for osteoarthritis. It can be easily matched for volume (\~10-12 mL) and appearance (using identical opaque syringes and study codes) to maintain effective blinding for participants, injecting physicians, and outcome assessors.

Placebo Saline Control Arm for Ankle; Placebo Saline Control Arm for Knee

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

Intervention will be an intra-articular injection of 15 units of HGH and 10 mL PRP conjunct. Five 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.
• Radiographically confirmed cartilage injury with Kellgren-Lawrence grade 1-3 can be shown on MRI scan or weight bearing X-Ray within 6 months of study application.
• Able to give informed consent to participate in a clinical trial.
• Able to commit to attending a 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 tumour.
• Skeletally immature (\<18 years of age or no radiographic evidence of closure of epiphyses).
• Pregnancy/breastfeeding (participants of childbearing potential need negative pregnancy test in prior screening and agreed upon method of contraception throughout duration of study)
• 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 degrees.
• Severe osteoarthritis (Kellgren-Lawrence grade 4 on baseline imaging), including bone-on-bone joints with no detectable cartilage.
• Known hypersensitivity to citrate or somatropin.
• Unable to give informed consent.
• Unable to commit to attend clinic for all follow ups.

Sponsors & Collaborators

• Integrant Pty Ltd: lead

Study Sites (1)

Integrant Office

Potts Point, New South Wales, 2011, Australia

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Reza Salleh, Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zadane F Bachmid

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be 4 arms of the study. One active treatment for ankle injections, one active treatment for knee injections, one saline placebo control group for ankle injections and one saline placebo control group for knee injections.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

AU (1)