Lyophilized Self‑Growth Factor versus PRP Injection for Knee Osteoarthritis

Comparing the Efficacy of Lyophilized Self Growth Factor Versus Platelet-Rich Plasma(PRP) Injection for Knee Osteoarthritis: A Prospective, Double-Blind, Randomized Controlled Trial

This trial tests whether a lyophilized self-growth factor injection works better than standard PRP or placebo at reducing pain and improving function in adults with mild-to-moderate knee osteoarthritis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Tri-Service General Hospital (other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06932614 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 20–80 with unilateral or bilateral mild-to-moderate knee osteoarthritis (Kellgren-Lawrence grades 1–3), symptoms for more than three months, and a baseline VAS pain score above 4 who have not had recent intra-articular steroid or hyaluronic acid injections are ideal candidates.

Not a fit: Patients with severe (KL grade 4) knee OA, active systemic infection, certain blood or clotting disorders, recent intra-articular steroid/HA injections within six months, recent major knee surgery, or uncontrolled serious comorbidities are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could offer a more effective, longer-lasting injection that reduces knee pain and improves mobility compared with standard PRP or placebo.

How similar studies have performed: PRP injections for knee osteoarthritis have produced mixed but sometimes favorable results in prior studies, while lyophilized or multi-step concentrated SRF formulations remain relatively novel and less well studied.

Eligibility criteria

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 this trial is running

Taipei

• No. 325, Sec. 2, Chenggong Rd., Neihu Dist. — Taipei, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Yu Chi Su,, MD

Conditions: Knee Osteoarthritis, PRP Injection, PRP injection