Osteoarthritis Knee
Conditions
Keywords
osteoarthritis knee, Mesenchymal Stem Cell, conditioned media
Brief summary
Osteoarthritis (OA) is a joint disorder that often occurs and causes disability. This disorder is characterized by an inflammatory reaction in the synovial joints accompanied by a gradual degeneration process in the articular cartilage and sub-chondral bone. Current research has discovered that stem cells produce conditioned media (secretome, extra vesicles, and exosomes) that have tissue regeneration, immunomodulation, anti-inflammatory, and anti-apoptotic capabilities. Research on conditioned media for umbilical cord mesenchymal stem cells is still at the in vivo stage in experimental animals. For this reason, this study aims to conduct clinical experimental research (translational study) in patients with knee joint OA who were given umbilical cord mesenchymal stem cell conditioned media via intra-articular injection.
Detailed description
The research was conducted as a clinical trial and translational study, involving a single group treated with intra-articular secretome injection therapy derived from hypoxic umbilical cord mesenchymal stem cell conditioned media. This study explores the clinical application of conditioned media from umbilical cord mesenchymal stem cells for treating knee OA. Our preliminary clinical trial involves administering this conditioned media via intra-articular injections to patients, followed by assessments using functional scores and MRI with T2 mapping sequence. This approach aims to harness the therapeutic potential of MSC derivatives in a clinical setting, offering a novel and potentially less invasive alternative to conventional OA treatments. The aim of this study is to evaluate the effectiveness of intra-articular injections of conditioned media from umbilical cord mesenchymal stem cells in improving knee joint function and structural integrity in patients with osteoarthritis, as assessed by MRI and functional scoring.
Interventions
BIOLOGICALIntra-articular secretome injection therapy
Intra-articular secretome injection therapy from hypoxic umbilical cord mesenchymal stem cell conditioned media
Sponsors
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* age over 45 years * primary knee joint OA Kellgrance-Lawrence grade 2 or 3, * never had surgery or intra-articular injection before,
Exclusion criteria
* currently experiencing local infections and/or systemic infections, * have a history of autoimmune disorders or immunodeficiency, * have had surgery or injections on the knee joint,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Score 1. Knee Injury and Osteoarthritis Outcome Score (KOOS), | 2,4,6 Months | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. |
| Functional Score 2. Knee Society Score (KSS) | 2,4,6 Months | The original KSS has a Knee Score section (7 items) and a Functional Score section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. |
| Functional Score 3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score | 2,4,6 Months | Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Evaluation | 2,4,6 Months | Magnetic Resonance Imaging Evaluation using CartiGram |
Countries
Indonesia
Outcome results
None listed