Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect
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|ClinicalTrials.gov Identifier: NCT02291926|
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cartilage Diseases Osteoarthritis||Biological: Human umbilical cord mesenchymal stem cells||Phase 1|
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|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||December 2016|
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Biological: Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.
Other Name: hUC-MSC
- Severity of adverse events [ Time Frame: 12 months ]Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0).
- Magnetic resonance imaging (MRI) of the knee [ Time Frame: Before and 1,3,6,12 month after treatment ]The size, depth of cartilage defect, and regenerated cartilage were measured using MRI.
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Before and 1,3,6,12 month after treatment ]Change in WOMAC pain score,composite score and function and stiffness index scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291926
|The Fifth Affiliated Hospital Immunotherapy center|
|Guangzhou, Guangdong, China, 510000|
|Principal Investigator:||Ping J Chen, Professor||The Fifth Affiliated Hospital of Guangzhou Medical University|