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

NCT06932614 | Recruiting

• 1 other identifier: C202404004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; PRP Injection

Keywords

Knee Osteoarthritis; PRP injection

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-treatment, 1st month, 2nd month, 3rd month, 6th month

Secondary Outcomes (3)

• Visual Analogue Scale

  Pre-treatment, 1st month, 2nd month, 3rd month, 6th month

• The intermittent and constant pain score , ICOAP

  Pre-treatment, 1st month, 2nd month, 3rd month, 6th month

• Timed Up and Go test

  Pre-treatment, 1st month, 2nd month, 3rd month, 6th month.

Study Arms (3)

Lyophilized self growth factor

EXPERIMENTAL

Knee Intraarticular injection with Lyophilized self growth factor

Procedure: Lyophilized self growth factor

Platelet-Rich Plasma(PRP)

ACTIVE COMPARATOR

Knee intraarticular injection with Platelet-Rich Plasma(PRP)

Procedure: Platelet-Rich Plasma(PRP)

normal saline

PLACEBO COMPARATOR

Knee intraarticular injection with normal saline

Procedure: Placebo

Interventions

Lyophilized self growth factor PROCEDURE

Knee Intraarticular injection with Lyophilized self growth factor

Lyophilized self growth factor

Platelet-Rich Plasma(PRP) PROCEDURE

Knee Intraarticular injection with Lyophilized self growth factor

Platelet-Rich Plasma(PRP)

Placebo PROCEDURE

Knee Intraarticular injection with normal saline

normal saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

No. 325, Sec. 2, Chenggong Rd., Neihu Dist.

Taipei, 114, Taiwan

RECRUITING

Related Publications (7)

• 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.

  PMID: 21437966 BACKGROUND

• Jo 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.

  PMID: 22366517 BACKGROUND

• Chavda 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.

  PMID: 35651409 BACKGROUND

• Arroll 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.

  PMID: 15039276 BACKGROUND

• Loeser 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.

  PMID: 22392533 BACKGROUND

• McAlindon 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.

  PMID: 24462672 BACKGROUND

• Neogi 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.

  PMID: 23973124 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Yu Chi Su,, MD

CONTACT

+886287923311; vickysu0110@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician and lecturer of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-04

Locations

TW (1)