Knee OsteoarthritisNCT06869200
Study on the Use of a Concentrated Growth Factor Preparation Kit for the Treatment of Knee Osteoarthritis
A study testing Concentrated Growth Factor (CGF) Intra-articular Injection and Platelet-Rich Plasma (PRP) Intra-articular Injection in people with Knee Osteoarthritis, run by Guangdong Hongzhi Health Technology at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Concentrated Growth Factor (CGF) Intra-articular Injection and Platelet-Rich Plasma (PRP) Intra-articular Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesChina
- Study dates
- 13 Mar 2025to 17 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Patients with severe hepatic or renal dysfunction [hepatic function indicators alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2 times the upper limit of normal; renal function indicators serum creatinine (Cr), blood urea nitrogen (BUN) > 2 times the upper limit of normal];
- Patients with hemoglobin < 10 g/dL or platelet count < 125 × 10^9/L;
Show all 11Show fewer
- Patients who have used any Chinese or Western medications or therapies for the treatment of knee osteoarthritis within 1 week prior to randomization;
- Patients who have received intra-articular injections or related drug therapies within the past 3 months;
- Women who are planning a pregnancy, breastfeeding, or pregnant during the entire clinical study period;
- Patients who have participated in other interventional drug or medical device clinical trials within 1 month prior to enrollment;
- Other situations where the investigator deems the patient unsuitable for participation in this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Third Affiliated Hospital,Sun Yat-Sen University.
Guangdong, Guangzhou, 510000
Nanfang Hospital,
Guangzhou, Guangdong, 510515
Shantou Central Hospital
Shantou, Guangdong, 515000
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
This study predefines the conversion between non-inferiority and superiority tests: first, a non-inferiority test is performed. If the non-inferiority conclusion is valid, a superiority test can be performed. If the superiority conclusion is valid, the research conclusion is superiority; if the superiority conclusion is invalid, the research conclusion is non-inferiority.
- Conditions
- Knee Osteoarthritis
- Being tested
- Concentrated Growth Factor (CGF) Intra-articular Injection, Platelet-Rich Plasma (PRP) Intra-articular Injection
- Keywords
- knee osteoarthritis, concentrated growth factors (CGF), platelet-rich plasma, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Intra-articular Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated Growth Factor (CGF) Intra-articular InjectionDevice
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.
Platelet-Rich Plasma (PRP) Intra-articular InjectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CGF Treatment Group | 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. Receives: Device: Concentrated Growth Factor (CGF) Intra-articular Injection |
| PRP Treatment Group | 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. Receives: Device: Platelet-Rich Plasma (PRP) Intra-articular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain, stiffness, and physical function in patients with hip and knee osteoarthritis. The score ranges from 0 to 96 (using a 5-point Likert scale), with lower scores indicating better outcomes.
Calculated as the absolute value of the difference between the WOMAC score at 1 month and the baseline score: |Score at 1 month - Score at baseline|.
Measured: 1 month after the 1st injection
Secondary outcomes (5)
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Calculated as the absolute value of the difference between the WOMAC score at 2 months and the baseline score: |Score at 2 months - Score at baseline|.
Measured: 2 months after the 1st injection
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Calculated as the absolute value of the difference between the WOMAC score at 3 months and the baseline score: |Score at 3 months - Score at baseline|.
Measured: 3 months after the 1st injection
Absolute Change in The Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain).
Measured: 1 month after the first injection
Absolute Change in The Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain).
Calculated as the absolute value of the difference between the VAS score at 1month and the baseline score: |Score at 2 month - Score at baseline|.
Measured: 2 months after the first injection
Absolute Change in The Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain).
Calculated as the absolute value of the difference between the VAS score at 3 months and the baseline score: |Score at 3 months - Score at baseline|.
Measured: 3 months after the first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start13 Mar 2025
- Primary completion3 Jul 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hongzhi Health Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanfang Hospital, Southern Medical University, Shantou Central Hospital, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869200
- Sponsor's protocol ID
- HZJKCGFOA202501
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2025
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06869200
- Acronym / sponsor ID
- HZJKCGFOA202501
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, concentrated growth factors (CGF), platelet-rich plasma, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Intra-articular Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Guangdong Hongzhi Health TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Nanfang Hospital, Southern Medical University, Shantou Central Hospital, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Posted 7 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study predefines the conversion between non-inferiority and superiority tests: first, a non-inferiority test is performed. If the non-inferiority conclusion is valid, a superiority test can be performed. If the superiority conclusion is valid, the research conclusion is superiority; if the superiority conclusion is invalid, the research conclusion is non-inferiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGF Treatment Group | Experimental | Device: Concentrated Growth Factor (CGF) Intra-articular InjectionParticipants 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. |
| PRP Treatment Group | Active comparator | Device: Platelet-Rich Plasma (PRP) Intra-articular InjectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
- Patients with severe hepatic or renal dysfunction [hepatic function indicators alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2 times the upper limit of normal; renal function indicators serum creatinine (Cr), blood urea nitrogen (BUN) > 2 times the upper limit of normal];
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentrated Growth Factor (CGF) Intra-articular InjectionPreparation 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 | CGF Treatment Group |
| Platelet-Rich Plasma (PRP) Intra-articular InjectionPreparation 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. | Device | PRP Treatment Group |
Primary outcome
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: 1 month after the 1st injection
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain, stiffness, and physical function in patients with hip and knee osteoarthritis. The score ranges from 0 to 96 (using a 5-point Likert scale), with lower scores indicating better outcomes. Calculated as the absolute value of the difference between the WOMAC score at 1 month and the baseline score: |Score at 1 month - Score at baseline|.
5 secondary outcomes
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: 2 months after the 1st injection
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: 3 months after the 1st injection
Absolute Change in The Visual Analog Scale (VAS) Score
Time frame: 1 month after the first injection
Absolute Change in The Visual Analog Scale (VAS) Score
Time frame: 2 months after the first injection
Absolute Change in The Visual Analog Scale (VAS) Score
Time frame: 3 months after the first injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated Growth Factor (CGF) Intra-articular Injection and Platelet-Rich Plasma (PRP) Intra-articular Injection in people with Knee Osteoarthritis, run by Guangdong Hongzhi Health Technology at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score (time frame: 1 month after the 1st injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.