Safety and Immunogenicity Evaluation of Allogeneic Mesenchymal Stem Cell Transplantation (Core Matrix Extracted)

Background and Aim: Among the stem cells, mesenchymal stem cells(MSCs) have garnered significant attention in the regenerative medicine,largely due to their anti-inflammatory and immunomodulatory properties.They can be easily isolated and cultured from many tissues, such as bonemarrow, adipose tissue, and umbilical cord. MSCs exhibit low expressionof MHC I but do not express MHC II or CO-stimulatory molecules suchas CD80 and CD81. So, they do not cause an immunological reactionafter they are infused into an allogeneic body. In this study, we evaluatethe safety and efficacy of allogeneic MSCs in patients with late-onsetneurometabolic disorders.Methods: This study is a community based and pragmatic, nonrandomizedsingle group, clinical trial without blinded postoperative careand outcome assessment. Wharton jelly-derived allogenic mesenchymalstem cells in suitable albumin solution were prepared in a clean room.After patient selection, one or much more injections planned byintrathecal and/or intravenous rout based on their organs involvements.3-4 million cell per kilogram more than 90% viability in 20-50 mLinjectable human albumin as a preservative in each intravenous injectionand one million per kilogram in 5-10 mL in each intrathecal injection.Interval of these injections was between 2 days to two weeks. Patientsunderwent a clinical and laboratory evaluation for a period of 18 monthsat defined intervals.Results: Historically, panel reactive antibody (PRA) analysis to detect HLAantibodies has been performed using cell-based complement-dependentcytotoxicity (CDC) techniques. Recently, a flow cytometric procedure(FlowPRA) was introduced as an alternative approach to detect HLAantibodies. Monitoring of anti-HLA class I and II antibodies was negativein 6 to 12 months after the first injection. In phase 1 of clinical trial no.30396 submitted in IRCT website, 3 patients (100%) had post-transplantanti-HLA class 1 and 2 antibodies detectable by FlowPRA lesser than 4that suggest negative immunogenicity in allogenic Wharton jelly-derivedmesenchymal stem cell transplantation.Conclusion: In this study, the immunogenicity of stem cells in theclinical phase was investigated, which measured the HLA class 1 and 2antibodies by flow PRA method, indicating a negative immunogenicityof these stem cells

کلیدواژه ها:

HLA antibody ، Warthon jelly ، Mesenchymal stem cell transplantation ، Allogenic