NCT06869200

Study on the Use of a Concentrated Growth Factor Preparation Kit for the Treatment of Knee Osteoarthritis

A Prospective, Multicenter, Single-Blind, Randomized Controlled Clinical Trial of an Autologous Platelet-Rich Concentrated Growth Factor (CGF) Preparation Kit for the Treatment of Knee Osteoarthritis

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Guangdong Hongzhi Health Technology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of an autologous platelet-rich concentrated growth factor (CGF) preparation kit for the treatment of knee osteoarthritis in patients diagnosed with this condition. The main question it aims to answer is: Can the CGF preparation kit effectively improve symptoms and reduce pain in patients with knee osteoarthritis compared to a control intervention? Researchers will compare the CGF treatment group to a control group using platelet-rich plasma (PRP) to see if the CGF intervention results in greater improvements in knee function and pain relief. Participants will: Undergo three intra-articular injections of CGF or PRP into the knee joint at weekly intervals. Complete assessments including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) for pain at specified intervals. Be monitored for safety and potential adverse events throughout the study period.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Concentrated Growth Factor (CGF) Intra-articular Injection	Preparation Method: The CGF is prepared using an autologous platelet-rich preparation kit specifically designed to concentrate growth factors from the patient's own blood. The process involves a specialized centrifugation technique that yields a high concentration of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and other bioactive molecules. Rationale: This intervention leverages the body's natural healing response by utilizing autologous growth factors to enhance the repair of cartilage and other joint tissues affected by osteoarthritis. The high concentration of bioactive molecules in CGF is believed to provide a more potent therapeutic effect compared to other platelet-rich therapies.
DEVICE	Platelet-Rich Plasma (PRP) Intra-articular Injection	Preparation Method: The PRP is prepared using a disposable PRP preparation device that separates and concentrates platelets from the patient's blood. This process enriches the plasma with platelets and associated growth factors. Rationale: PRP has been widely used in clinical practice for its ability to promote tissue healing and reduce inflammation in osteoarthritis. It serves as an active comparator in this study, allowing for a direct comparison of the therapeutic efficacy and safety profile of CGF against a well-established treatment modality.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-31
• Completion: 2026-02-01
• First posted: 2025-03-11
• Last updated: 2025-03-19

Locations

3 sites across 1 country: China