None listed
Conditions
Interventions
Procedure/Surgery : The subjects who were enrolled in the study were treated with intra-articular knee injection of 2 mL PN filler (HP cell Vitaran J, BRPHARM Co., Ltd., South Korea) at each visit for
Sponsors
Yonsei University, Wonju Severance Christian Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female adults aged = 40 and < 80 2) Voluntarily signed the written informed consent form 3) Ability to understand and comply with the study procedures and visit schedule 4) Diagnosis of arthritis according to the American College of Rheumatology (ACR) classification criteria at the screening visit 5) Kellgren-Lawrence Grade of II to IV for the severity of arthritis based on a knee X-ray at the screening visit 6) Visual Analogue Scale (VAS) at rest score of = 40 mm at the screening visit 7) Women of childbearing potential who has agreed to use a contraception method throughout the study
Exclusion criteria
Exclusion criteria: 1) Intra-articular injection to the knee within 6 months prior to screening 2) History of a knee surgery 3) Other diseases (presence or prior history of an autoimmune disease, myocardial infarction, cardiac arrest, severe heart disease, or uncontrolled hypertension) that may affect or interfere with the therapeutic effect 4) Chronic inflammatory diseases such as rheumatoid arthritis 5) Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 48 hours prior to screening 6) Use of immunosuppressants such as cyclosporine A or azathioprine within 6 weeks prior to screening 7) Orthopaedic diseases that may affect or interfere with the therapeutic effect 8) Habitual use of psychotropic or narcotic analgesics for = 1 week within 8 weeks prior to screening 9) Psychological or psychiatric disorders that may affect a subject's participation in the study 10) More severe pain in other areas of the body than in the knee bone and joint at the screening visit 11) Ligament instability of = Grade II on the physical examination at the screening visit (Grade 0: no; Grade I: 0 - 5 mm; Grade II: 5 - 10 mm; Grade III: >10 mm) 12) Skin abnormalities such as infection or skin disease on the injection site 13) Pregnant or breastfeeding women (Women of childbearing potential must have a pregnancy test and cannot participate in the study if they are planning for pregnancy or are unwilling to use appropriate contraception methods.) 14) Participated in other intervention studies within 30 days prior to screening 15) Inability to communicate or follow instructions 16) Determined to be ineligible for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale;K-WOMAC osteoarthritis index | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory cytokine markers of synovium (IL-6, IL-10, TNF- a);BSV of Artificial intelligence based alrgorithm analysis of Knee X ray | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Yoon Jang
Yonsei University Wonju College of Medicine
Outcome results
None listed