CompletedNot Applicable

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

China104 participantsStarted 2025-03-13

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years, with no gender restrictions; * Patients diagnosed with knee osteoarthritis according to the "Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2024 Edition)" by the Chinese Osteoarthritis Diagnosis and Treatment Guidelines Expert Group; * Radiographic evidence of knee osteoarthritis with Kellgren-Lawrence grading of II to IV; * Visual Analog Scale (VAS) pain score ≥ 4 (moderate or higher pain) and WOMAC score ≥ 24; * For participants with eligible bilateral knee osteoarthritis, the more severely affected knee will be treated, while the other knee will not be intervened during the study period. If the severity is equal on both sides, the left knee will be selected for intervention; * The patient or their legal guardian is able to understand the purpose of the study and provide informed consent. Exclusion Criteria: * Patients with a confirmed diagnosis of other inflammatory diseases of the knee joint, such as rheumatoid arthritis, psoriatic arthritis, or gouty arthritis; Patients with a confirmed diagnosis of bleeding disorders (e.g., allergic purpura, hemophilia, idiopathic thrombocytopenic purpura), hematologic malignancies (e.g., leukemia), or those with unconfirmed bleeding disorders but coagulation dysfunction (coagulation parameters PT, APTT, INR \> 1.5 times the upper limit of normal); * Patients who have undergone or are planned to undergo knee osteoarthritis surgery within the past 6 months or during the tria…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used something called a Concentrated Growth Factor preparation — can you explain what that actually is, how it's made from a patient's own blood, and whether it's similar to other treatments like PRP that you might already offer?
2The trial measured changes in the WOMAC score, which tracks pain, stiffness, and physical function in knee osteoarthritis — based on what this trial found, did patients actually report meaningful improvements in those areas, and how do those results compare to standard treatments like physical therapy or steroid injections?
3Since this trial is already completed, is the data published anywhere, and can we look at it together to understand how well the treatment worked and whether any side effects were reported?
4This trial is listed as 'Phase NA,' which sometimes applies to device or procedure studies rather than drug trials — does that change how we should think about the strength of the evidence, and would this approach be considered experimental if I pursued it?
5Given that my specific level of knee osteoarthritis severity might differ from the patients enrolled in this trial, do you think my situation would be comparable to the people they studied, and is this something worth considering for me or should we explore other options first?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

Timeframe: 1 month after the 1st injection

Trial details

NCT IDNCT06869200

SponsorGuangdong Hongzhi Health Technology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-03

Results submitted2026-03-12

View on ClinicalTrials.gov More Knee Osteoarthritis trials