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

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. Study design: Prospective, multicenter, single-blind, randomized controlled, non-inferiority clinical trial. Sample size: 104 cases, with 52 cases in the experimental group and 52 cases in the control group.

NCT Number	NCT06869200
Lead Sponsor	Guangdong Hongzhi Health Technology Collaborators: Nanfang Hospital, Southern Medical University, Shantou Central Hospital, Third Affiliated Hospital, Sun Yat-Sen University
Conditions	Knee Osteoarthritis
Enrollment	104 participants
Start Date	2025-03-13
Primary Completion	2025-07-03 (estimated)
Study Completion	2025-09-17 (estimated)
Updated on ClinicalTrials.gov	2026-07-07