EVALUATE THE SAFETY OF MESENCHYMAL STEM CELLS DERIVED FROM ALLOGENEIC UMBILICAL CORD TISSUE FROM NEWBORN UMBILICAL CORD TISSUE THERAPY IN THE TREATMENT OF KNEE OSTEOARTHRITIS

Abstract

Background: Mesenchymal stem cells derived from allogeneic umbilical cord tissue from newborn umbilical cord tissue (hUCB-MSCs) have feature the following advantages: non-invasive collection, hyaline embryonic tissue structure similar to tendon, low immunogenicity. This approach is, expected to treat knee osteoarthritis (OA) because of the for its ability to proliferate and differentiate into connective tissue cells, secrete immunoregulatory factors, anti-inflammatory, regenerative blood vessels, prevent apoptosis, . but However, there are still many concerns about safety of this methods.

Objective: Evaluate the safety of hUCB-MSCs therapy in treatment of primary OA.

Methods: Prospective, open-label, placebo-controlled study on 65 patients with stage I-III OA according to Kellgren-Lawrence, 32 patients received intra-articular injection of hUCB-MSCs, 33 patients received hyaluronic acid.

Results: The most common adverse event was pain at the time of injection with a rate of 40.6% in the study group and 36.4% in the control group, increased pain after injection was 37.5% and 6.3%, respectively, the difference was statistically significant with p <0.05; there was no infection in the joint and soft tissue around the joint, post-injection joint bleeding, the level of post-injection effusion did not have a statistically significant difference in the 2 groups.

Conclusion: Using hUCB-MSCs by intra-articular injection to treat OA is safe, however, research with larger sample sizes and longer follow-up time is needed for better evaluation.

Key words: allogeneic mesenchymal stem cells from umbilical cord tissue; knee osteoarthritis; hyaluronic acid; safety