The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.
Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells. To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.
The Fifth Affiliated Hospital Immunotherapy center
Guangzhou, Guangdong, China
Severity of adverse events
Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0).
Time frame: 12 months
Magnetic resonance imaging (MRI) of the knee
The size, depth of cartilage defect, and regenerated cartilage were measured using MRI.
Time frame: Before and 1,3,6,12 month after treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Change in WOMAC pain score,composite score and function and stiffness index scores.
Time frame: Before and 1,3,6,12 month after treatment
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