Knee OsteoarthritisNCT06932614
Comparing the Efficacy of Lyophilized Self Growth Factor Versus PRP Injection for Knee OA
A study testing Lyophilized self growth factor and Platelet-Rich Plasma(PRP) in people with Knee Osteoarthritis and PRP Injection, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, PRP Injection
- What is being tested?
- Lyophilized self growth factor and Platelet-Rich Plasma(PRP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
No. 325, Sec. 2, Chenggong Rd., Neihu Dist.
Taipei, 114
Yu Chi Su, MD, +886-2-8792-3311, vickysu0110@gmail.com
About this study
Official title: Comparing the Efficacy of Lyophilized Self Growth Factor Versus Platelet-Rich Plasma(PRP) Injection for Knee Osteoarthritis: A Prospective, Double-Blind, Randomized Controlled Trial
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.
Read the 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
- Being tested
- Lyophilized self growth factor, Platelet-Rich Plasma(PRP), Placebo
- Keywords
- Knee Osteoarthritis, PRP injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized self growth factorProcedure or surgery
Knee Intraarticular injection with Lyophilized self growth factor
Platelet-Rich Plasma(PRP)Procedure or surgery
Knee Intraarticular injection with Lyophilized self growth factor
PlaceboProcedure or surgery
Knee Intraarticular injection with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Lyophilized self growth factor | Experimental | Knee Intraarticular injection with Lyophilized self growth factor Receives: Procedure: Lyophilized self growth factor |
| Platelet-Rich Plasma(PRP) | Active comparator | Knee intraarticular injection with Platelet-Rich Plasma(PRP) Receives: Procedure: Platelet-Rich Plasma(PRP) |
| normal saline | Placebo comparator | Knee intraarticular injection with normal saline Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index
The structure and function of the knee joint are assessed from three main aspects: pain, stiffness, and joint function, with a total of 24 items. The pain section consists of 5 items (24 points in total), the stiffness section has 2 items (8 points in total), and the joint function section includes 17 items (68 points in total). A lower score indicates more severe pain, stiffness, and a higher degree of disability.
Measured: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
Secondary outcomes (3)
Visual Analogue Scale
Change from baseline of pain on 1st month, 2nd month, 3rd month, 6th month after injection.
Pain severity was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain
Measured: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
The intermittent and constant pain score , ICOAP
The content is divided into two subcategories: continuous pain (5 items) and intermittent pain (6 items), with a total of 11 items. Each item is scored from 0, representing no pain, to 4, representing extreme pain. A higher score indicates more severe pain. The Chinese version has reliable validity and reliability.
Measured: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
Timed Up and Go test
Align the chair legs with the starting baseline and place a cone 3 meters ahead. The participant sits in the chair with their feet naturally bent, stands up comfortably, walks forward for 3 meters, turns around, and walks back to sit down. The time taken to complete the task is recorded. This test has good validity and reliability for assessing the mobility of patients with degenerative knee osteoarthritis.
Measured: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Aug 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-CHI Su, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932614
- Sponsor's protocol ID
- C202404004
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Woodell-May J, Matuska A, Oyster M, Welch Z, O'Shaughnessey K, Hoeppner J. Autologous protein solution inhibits MMP-13 production by IL-1beta and TNFalpha-stimulated human articular chondrocytes. J Orthop Res. 2011 Sep;29(9):1320-6. doi: 10.1002/jor.21384. Epub 2011 Mar 15.
PubMed 21437966Jo CH, Kim JE, Yoon KS, Shin S. Platelet-rich plasma stimulates cell proliferation and enhances matrix gene expression and synthesis in tenocytes from human rotator cuff tendons with degenerative tears. Am J Sports Med. 2012 May;40(5):1035-45. doi: 10.1177/0363546512437525. Epub 2012 Feb 23.
PubMed 22366517Chavda S, Rabbani SA, Wadhwa T. Role and Effectiveness of Intra-articular Injection of Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Systematic Review. Cureus. 2022 Apr 26;14(4):e24503. doi: 10.7759/cureus.24503. eCollection 2022 Apr.
PubMed 35651409Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004 Apr 10;328(7444):869. doi: 10.1136/bmj.38039.573970.7C. Epub 2004 Mar 23.
PubMed 15039276Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available.
PubMed 22392533McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
PubMed 24462672Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.
PubMed 23973124
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Lyophilized Self Growth Factor Versus Platelet-Rich Plasma(PRP) Injection for Knee Osteoarthritis: A Prospective, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06932614
- Acronym / sponsor ID
- C202404004
- Conditions
- Knee Osteoarthritis, PRP Injection
- Keywords
- Knee Osteoarthritis, PRP injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lyophilized self growth factor | Experimental | Procedure: Lyophilized self growth factorKnee Intraarticular injection with Lyophilized self growth factor |
| Platelet-Rich Plasma(PRP) | Active comparator | Procedure: Platelet-Rich Plasma(PRP)Knee intraarticular injection with Platelet-Rich Plasma(PRP) |
| normal saline | Placebo comparator | Procedure: PlaceboKnee intraarticular injection with normal saline |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyophilized self growth factorKnee Intraarticular injection with Lyophilized self growth factor | Procedure or surgery | Lyophilized self growth factor |
| Platelet-Rich Plasma(PRP)Knee Intraarticular injection with Lyophilized self growth factor | Procedure or surgery | Platelet-Rich Plasma(PRP) |
| PlaceboKnee Intraarticular injection with normal saline | Procedure or surgery | normal saline |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
The structure and function of the knee joint are assessed from three main aspects: pain, stiffness, and joint function, with a total of 24 items. The pain section consists of 5 items (24 points in total), the stiffness section has 2 items (8 points in total), and the joint function section includes 17 items (68 points in total). A lower score indicates more severe pain, stiffness, and a higher degree of disability.
3 secondary outcomes
Visual Analogue Scale
Time frame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
The intermittent and constant pain score , ICOAP
Time frame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
Timed Up and Go test
Time frame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Results publication: PubMed 21437966Woodell-May J, Matuska A, Oyster M, Welch Z, O'Shaughnessey K, Hoeppner J. Autologous protein solution inhibits MMP-13 production by IL-1beta and TNFalpha-stimulated human articular chondrocytes. J Orthop Res. 2011 Sep;29(9):1320-6. doi: 10.1002/jor.21384. Epub 2011 Mar 15.
- Results publication: PubMed 22366517Jo CH, Kim JE, Yoon KS, Shin S. Platelet-rich plasma stimulates cell proliferation and enhances matrix gene expression and synthesis in tenocytes from human rotator cuff tendons with degenerative tears. Am J Sports Med. 2012 May;40(5):1035-45. doi: 10.1177/0363546512437525. Epub 2012 Feb 23.
- Results publication: PubMed 35651409Chavda S, Rabbani SA, Wadhwa T. Role and Effectiveness of Intra-articular Injection of Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Systematic Review. Cureus. 2022 Apr 26;14(4):e24503. doi: 10.7759/cureus.24503. eCollection 2022 Apr.
- Results publication: PubMed 15039276Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004 Apr 10;328(7444):869. doi: 10.1136/bmj.38039.573970.7C. Epub 2004 Mar 23.
- Results publication: PubMed 22392533Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available.
- Results publication: PubMed 24462672McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
- Results publication: PubMed 23973124Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyophilized self growth factor and Platelet-Rich Plasma(PRP) in people with Knee Osteoarthritis and PRP Injection, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Chi Su,, MD (+886287923311, vickysu0110@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (time frame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06932614, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.