Lyophilized Self‑Growth Factor versus PRP Injection for Knee Osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with mild-to-moderate knee osteoarthritis and persistent symptoms are randomized in a double-blind design to receive intra-articular injections of lyophilized self-repair factor (SRF), conventional platelet-rich plasma (PRP), or placebo. SRF is produced with multi-step centrifugation and proprietary processing to concentrate platelets and growth factors, then lyophilized for administration, while PRP is prepared from the patient’s own blood using standard centrifugation. The trial compares pain scores, functional outcomes, and safety over scheduled follow-up visits to determine whether the enhanced SRF offers superior clinical benefit to PRP or placebo. Procedures include baseline imaging confirmation of Kellgren-Lawrence grade 1–3 OA and monitoring for adverse events after injection.

Why it matters

Who can join: the full rules

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.

Where it's running

• No. 325, Sec. 2, Chenggong Rd., Neihu Dist.
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Yu Chi Su,, MD
• Email: vickysu0110@gmail.com
• Phone: +886287923311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.