Clinical Study of Intra articular injection of Catholic MASTER cell (bone marrow derived mesenchymal stem cell) in Knee osteoarthritis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0004420
- Brief Summary
A single intra-articular injection of allogenic BM-MSCs provided satisfactory pain relief for patients with knee OA compared to control group at 9 months. Also, a comparison of T2 values from quantitative T2 MRI mapping for cartilage between two groups showed that IA BM-MSCs could have a preventive effect on OA progression at 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
1.Age 20-80
2.diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for knee OA
3.symptomatic OA that lastede for at least 3 months before screening
4.Baseline Pain VAS =50 mm
5.treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due to OA pain
6.X-ray Kellgren-Lawrence grade 1~4
7.volauntarily enrolled with informed consent
8.no improvement with medical treatment for at least 3months
1.disease in spine or lower extremities that can affect the outcome of index knee
2.surgery on lower extremities within 6month before injection or planned
3.joint symptoms that can affect the interpretation of the trial data or prevent the subject from enrollement including but not limited to symptomatic fracture, fibromyalgia, rheumatoid arthritis, reactive arthritis
4.steroid injection to the index knee within preivious 3months
5.hyaluronic acid injection to the index knee within preivious 6months
6.underwent cell therapy or gene therapy in the past
7.more than 3 times upper normal limit in one or more of the followings: serum creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or more than 3 times upper normal limit in two or more of the followings: bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
8.participation in a different clinical trial other than this within 4 weeks after initiation of the current study
9.use (reccuent use or addiction) of substances that can affect pain sensation such as narcotics
10.females of childbearing age who do not consent to effective contraceptive methods during the study period
11.pregnant or lactating woman
12.malignancy
13. considered to be inappropriate for the trial by investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method adverse event according to CTCAE 5.0, clinically meaningful abnormalites in laboratory tests (blood/urine)
- Secondary Outcome Measures
Name Time Method Western Ontario and McMaster Universities Arthritis Index (WOMAC) score;Knee injury and Osteoarthritis Outcome Score (KOOS);international knee documentation committee (IKDC);knee MRI;SF -36 questionnaire;serum inflammatory cytokine, acute phase reactant, bone turnover marker;knee x-ray