Clinical trial NCT06869200: Study on the Use of a Concentrated Growth Factor Preparation Kit for the Treatment of Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
concentrated growth factors (CGF)
platelet-rich plasma
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Intra-articular Injection
Lead sponsor: Guangdong Hongzhi Biotechnology Co.
Sponsor class: INDUSTRY
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Shantou Central Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2025-03-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 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;
* 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.

Primary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: One month after the first injection
Secondary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 2 and 3 month after the first injection
measure: The Visual Analog Scale (VAS)
timeFrame: 1，2，and 3 month after the first injection
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital,
state: Guangdong
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
city: Guangdong
country: China
facility: The Third Affiliated Hospital,Sun Yat-Sen University.
state: Guangzhou
Study officials:
References:
citation: Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24.
citation: Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.
citation: Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
citation: Molnar V, Matisic V, Kodvanj I, Bjelica R, Jelec Z, Hudetz D, Rod E, Cukelj F, Vrdoljak T, Vidovic D, Staresinic M, Sabalic S, Dobricic B, Petrovic T, Anticevic D, Boric I, Kosir R, Zmrzljak UP, Primorac D. Cytokines and Chemokines Involved in Osteoarthritis Pathogenesis. Int J Mol Sci. 2021 Aug 26;22(17):9208. doi: 10.3390/ijms22179208.