Enrolling by invitation

Autologous CGF Kit for Knee Osteoarthritis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Concentrated Growth Factor (CGF) Intra-articular Injection

+ Platelet-Rich Plasma (PRP) Intra-articular Injection

Device
Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorGuangdong Hongzhi Biotechnology Co.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is set up to find out if a new treatment using an autologous platelet-rich concentrated growth factor (CGF) preparation kit can help people with knee osteoarthritis. The study targets individuals who have been diagnosed with this condition, which causes joint pain and stiffness. Researchers hope to see if this new treatment can offer better relief from symptoms and improve knee function compared to a standard treatment using platelet-rich plasma (PRP). This research is important because it could lead to a new way to manage knee osteoarthritis, providing better pain relief and improved mobility for those affected. Participants in the study will receive three injections directly into the knee joint, either with the CGF or PRP, once a week. Throughout the study, they will fill out special surveys like the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a Visual Analog Scale (VAS) to measure pain and knee function. Participants will be closely monitored to ensure their safety and to track any side effects. By doing so, the study aims to gather clear evidence on whether the CGF treatment is more effective than the current PRP approach.

Official TitleA 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
NCT06869200
Principal SponsorGuangdong Hongzhi Biotechnology Co.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee

Criteria

6 inclusion criteria required to participate
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;

Show More Criteria

11 exclusion criteria prevent from participating
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 trial period;

Patients with local infections at the injection site (e.g., septic arthritis, tuberculous arthritis, or local soft tissue infections) or severe systemic infections (e.g., sepsis);

Patients with untreated malignant diseases such as malignancies, which may interfere with the safety and efficacy assessments of the study and affect the patient's participation in the study;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.

Group II

Active Comparator
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Nanfang Hospital,

Guangzhou, ChinaOpen Nanfang Hospital, in Google Maps
Suspended

Shantou Central Hospital

Shantou, China
Suspended

The Third Affiliated Hospital,Sun Yat-Sen University.

Guangdong, China
Enrolling by invitation3 Study Centers