NCT06932614

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 degenerative knee osteoarthritis.

Detailed description

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. Treatment options include weight loss, anti-inflammatory and pain-relieving medications, physical rehabilitation, and intra-articular injections of corticosteroids or hyaluronic acid. However, these methods often have limited efficacy or may cause side effects. 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. However, there is still lack of strong evidence of the therapeutic effects of PRP injection in knee OA. Therefore, there is a need to investigate novel therapies for 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 degenerative knee osteoarthritis. Patients with mild to moderate knee osteoarthritis who have experienced symptoms for more than three months. 30 participants will be recruited and randomly divided into three groups: the SRF group, the PRP group, and a control group. Each participant will receive knee intra-articular injections as part of a three-month treatment regimen, with one injection per month for a total of three injections. Patients will be evaluated before the trial, and at one, two, three, and six months after the injections. Clinical outcomes will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Intermittent and Constant Osteoarthritis Pain (ICOAP) scale, the sit-to-stand test, and the Visual Analog Scale (VAS) for pain. The study aims to confirm the clinical efficacy of SRF in treating degenerative knee osteoarthritis.

Conditions

• Knee Osteoarthritis
• PRP Injection

Interventions

Type	Name	Description
PROCEDURE	Lyophilized self growth factor	Knee Intraarticular injection with Lyophilized self growth factor
PROCEDURE	Platelet-Rich Plasma(PRP)	Knee Intraarticular injection with Lyophilized self growth factor
PROCEDURE	Placebo	Knee Intraarticular injection with normal saline

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-04-17
• Last updated: 2025-09-10

Locations

1 site across 1 country: Taiwan