Autologous protein solution inhibits MMP-13 production by IL-1β and TNFα-stimulated human articular chondrocytes.
Jennifer Woodell-May, Andrea Matuska, Megan Oyster...
https://pubmed.ncbi.nlm.nih.gov/21437966Actively Recruiting
Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID06932614
Comparing the Efficacy of Lyophilized Self Growth Factor Versus Platelet-Rich Plasma(PRP) Injection for Knee Osteoarthritis: A Prospective, Double-Blind, Randomized Controlled Trial
Led by Tri-Service General Hospital · Updated on 2025-09-10
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Knee osteoarthritis (OA) is a common joint disease leading to pain, stiffness, and reduced quality of life mainly in middle-aged and older adults. Researchers are comparing an advanced form of platelet-rich plasma called Self-repair factor (SRF) with traditional PRP to see which is more effective for treating degenerative knee OA. This study uses a randomized, double-blind design to evaluate these treatments alongside a placebo for better understanding of their effects. Participants are divided into three groups receiving monthly knee injections for three months: one group gets lyophilized SRF, another receives PRP, and the third group is given normal saline as a placebo. SRF is produced using enhanced centrifugation to increase platelet concentration, potentially improving healing and recovery compared to conventional PRP. The treatment phase lasts three months with injections each month. Throughout the study, participants undergo evaluations before treatment and at one, two, three, and six months after injections. Assessments include the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain scales such as the Visual Analog Scale (VAS) and ICOAP, and physical tests like the sit-to-stand test. These measures help researchers understand treatment effects on pain, function, and mobility while monitoring safety and participant progress over six months.
CONDITIONS
Brief Title
Comparing the Efficacy of Lyophilized Self Growth Factor Versus PRP Injection for Knee OA
Who Can Participate
Age: 20Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female, aged over 20 and under 80.
- Clear consciousness and ability to communicate.
- Unilateral or bilateral knee osteoarthritis with symptoms lasting more than 3 months.
- Mild to moderate knee osteoarthritis confirmed by X-ray (Kellgren-Lawrence grades 1-3).
- Knee pain with a Visual Analogue Scale (VAS) score greater than 4.
You will not qualify if you...
- Severe knee osteoarthritis (Kellgren-Lawrence grade 4).
- Current systemic infection.
- Hyaluronic acid or corticosteroid knee injections within the past 6 months, or NSAIDs/oral corticosteroids within 7 days before treatment.
- Previous joint replacement or major surgery on the treated knee.
- Severe knee deformity or instability.
- History of cancers, rheumatoid arthritis, platelet dysfunction, thrombocytopenia, hypofibrinogenemia, acute/chronic infections, chronic liver disease, or poorly controlled cardiovascular disease or diabetes.
- Currently on 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 those unable to use effective contraception during treatment.
- Deemed unsuitable by the principal investigator.
- Unable to sign informed consent form.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive three knee intra-articular injections, one injection per month, using either Lyophilized Self Growth Factor, Platelet-Rich Plasma, or placebo over a three-month period.
3 injection visits (in-person), one per month
Follow-up
Duration - 3 months after treatment ends
Participants are evaluated at one, two, three, and six months after the first injection to assess clinical outcomes including pain and function.
4 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
No. 325, Sec. 2, Chenggong Rd., Neihu Dist.
Taipei, Taiwan, 114
Actively Recruiting
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Research Team
Y
Yu Chi Su,, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Chris Hyunchul Jo, Ji Eun Kim, Kang Sup Yoon...
https://pubmed.ncbi.nlm.nih.gov/22366517Role and Effectiveness of Intra-articular Injection of Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Systematic Review.
Sumant Chavda, Syed Arman Rabbani, Tarun Wadhwa
https://pubmed.ncbi.nlm.nih.gov/35651409Corticosteroid injections for osteoarthritis of the knee: meta-analysis.
Bruce Arroll, Felicity Goodyear-Smith
https://pubmed.ncbi.nlm.nih.gov/15039276Osteoarthritis: a disease of the joint as an organ.
Richard F Loeser, Steven R Goldring, Carla R Scanzello...
https://pubmed.ncbi.nlm.nih.gov/22392533OARSI guidelines for the non-surgical management of knee osteoarthritis.
T E McAlindon, R R Bannuru, M C Sullivan...
https://pubmed.ncbi.nlm.nih.gov/24462672The epidemiology and impact of pain in osteoarthritis.
T Neogi
https://pubmed.ncbi.nlm.nih.gov/23973124