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

Официальное название

Investigation of Intra-Articular Growth Hormone and Platelet-Rich Plasma on Joint Health in Adults With Knee and Ankle Arthritis Resistant to Treatment

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Ankle mobility and functionality test with AOFAS scale [Срок оценки: Baseline, 3-months after final injection, 6-months after final injection]
• Knee mobility and functionality test with AKS scale [Срок оценки: Baseline, 3-months after final injection, 6-months after final injection]

Вторичные конечные точки (2)

• MRI Imaging of the affected arthritic joint [Срок оценки: Baseline, 6-months after final injection]
• Blood test for hormone [Срок оценки: Baseline, 2 hours after each injection]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Dr Gordon Slater: Orthopaedic Surgeon — Potts Point

Идентификаторы

NCT: NCT06907121 · INT-2025-02-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗