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Comparing the Efficacy of Lyophilized Self Growth Factor Versus PRP Injection for Knee OA

RecruitingNAAges 20 Years - 80 YearsAllTri-Service General Hospital (TSGH)
NCT06932614 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Knee osteoarthritis(OA) is a common degenerative joint disease that often leads to knee pain, stiffness, and a decline in quality of life among middle-aged and elderly individuals. Platelet-rich plasma (PRP) is a regenerative treatment method that involves drawing a small amount of the patient's own blood and using centrifugation process to produce PRP. PRP, which is rich in growth factors and anti-inflammatory cytokines, facilitate the repair of damaged tissues and has been used in treating knee OA. Self-repair factor (SRF), an advanced form of PRP, is created using multi-step centrifugation and proprietary processes to increase platelet concentration. This enhancement may offer superior repair efficacy and faster recovery compared to traditional PRP. To explore this potential, we designed a randomized, double-blind, clinical trial to compare the effectiveness of SRF and PRP in treating

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female, aged over 20 and under 80. * Consciousness clear and able to communicate. * Unilateral or bilateral osteoarthritis of the knee with symptoms lasting more than 3 months. * X-ray imaging shows mild to moderate knee osteoarthritis (Kellgren-Lawrence grades 1-3). * Knee joint pain with a Visual Analogue Scale (VAS) score greater than 4. Exclusion Criteria: * Severe knee osteoarthritis (Kellgren-Lawrence grade 4). * Currently systemic infection. * Received hyaluronic acid or corticosteroid intraarticular injections within the past six months, or received NSAIDs or oral corticosteroid treatment within 7 days prior to treatment. * The treated joint has undergone joint replacement surgery or major surgery. * Severe knee deformity or instability. * Known history of cancers, rheumatoid arthritis, platelet dysfunction, thrombocytopenia, hypofibrinogenemia, acute or chronic infectious diseases, chronic liver disease, or poorly controlled cardiovascular disease or diabetes. * Currently receiving anticoagulant therapy. * Long-term or excessive use of aspirin or vitamin E. * History of HIV/AIDS, syphilis, or other legally notifiable infectious diseases. * Pregnant or breastfeeding women, or women and men of childbearing potential who are unable to use effective contraception during the treatment period. * Deemed unsuitable for participation in the trial by the principal investigator. * Unable to sign the informed consent form.
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What it tests

  • Lyophilized self growth factor
  • Platelet-Rich Plasma(PRP)
  • Placebo
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Where

1 site
No. 325, Sec. 2, Chenggong Rd., Neihu Dist.
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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