The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of human knee OA
This is a single-centre, quadruple blined, randomized controlled trail with a total of 9 knee osteoarthrits patients as participants, who will be randomly assigned into high dose group, moderate dose group or low dose group. The participants in the high dose group will receive the treatment of high dose MSCs (1×10\^8cells/3mL) anticular injection.The dose of the MSCs in medium dose group is 5×10\^7cells/3mL, and the dose in the low dose group is 1×10\^7cells/3mL. Unexplained local and systemic symptoms will be assessed to determine the the maximum tolerated dose of mesenchymal stem cells in anticular injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
we will enroll three groups of patients, and they will be therapized by high, medium, and low-dose cytotoxic respectively to evaluate the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD). Dose and cell concentration selection will be based on previous literature \[5\]. The low-dose is 1 × 10\^7cells / 3mL, the medium-dose is 5 × 10\^7cells / 3mL and the high dose is 1 × 10\^8cells / 3mL
Unexplained local and systemic symptoms or death
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.