None listed
Conditions
Interventions
Drug, Medical Device : Upon voluntary signing of the informed consent form, eligible participants meeting the inclusion and exclusion criteria will be randomly assigned to either the CartiPRO® investi
Sponsors
Dalim Tissen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects aged 19 years or older, male or female, diagnosed with unilateral or bilateral knee osteoarthritis according to the American College of Rheumatology guidelines, with Kellgren & Lawrence grade 1 to 3, and at least one knee joint having a 100-mm Weight-Bearing Pain Visual Analogue Scale score of =40 mm, who are able to walk without the aid of a walker or cane.
Exclusion criteria
Exclusion criteria: Subjects with a Body Mass Index = 32 kg/m² or with cardiovascular disease, a history of autoimmune disease or use of immunosuppressive agents, a history of psychiatric disorders or epilepsy, a history of cancer, or who are pregnant or breastfeeding, and those with skin disorders at the injection site or unsuitable conditions for injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 100-mm Weight-Bearing Pain Visual Analogue Scale score at Week 12 after the first injection compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 100-mm Weight-Bearing Pain Visual Analogue Scale score;Change in total and subscale (pain, stiffness, physical function) scores of the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) index;Change in domain scores of the 36-Item Short Form Health Survey (physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health);Change in 100-mm Resting Pain Visual Analogue Scale score;Change in 100-mm Motion Pain Visual Analogue Scale score;Change in 100-mm Night Pain Visual Analogue Scale score | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunah Kwon
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed