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10.1186/s12967-015-0700-0 http://scihub22266oqcxt.onion/10.1186/s12967-015-0700-0 C4632480!4632480 !26537851     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=26537851 &cmd=llinks): Failed to open stream: HTTP request failed! 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Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients: the neptune study |pdf=|usr=}}{{26537851 }} gab.com Text Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients: the neptune study JO: J Transl Med http://www.kidney.de/pget.php?&tw=1&pmid=26537851 #FOAvip BACKGROUND: Mesenchymal stromal cells (MSC) may serve as an attractive therapy in renal transplantation due to their immunosuppressive and reparative properties. While most studies have used autologous MSCs, allogeneic MSCs offer the advantage of immediate availability for clinical use. This is of major importance for indications where instant treatment is needed, for example allograft rejection or calcineurin inhibitor toxicity. Clinical studies using allogeneic MSCs are limited in number. Although these studies showed no adverse reactions, allogeneic MSCs could possibly elicit an anti-donor immune response, which may increase the incidence of rejection and impact the allograft survival in the long term. These safety issues should be addressed before further studies are planned with allogeneic MSCs in the solid organ transplant setting. METHODS/DESIGN: 10 renal allograft recipients, 18-75 years old, will be included in this clinical phase Ib, open label, single center study. Patients will receive two doses of 1.5 × 10(6) per/kg body weight allogeneic bone marrow derived MSCs intravenously, at 25 and 26 weeks after transplantation, when immune suppression levels are reduced. The primary end point of this study is safety by assessing biopsy proven acute rejection (BPAR)/graft loss after MSC treatment. Secondary end points, all measured before and after MSC infusions, include: comparison of fibrosis in renal biopsy by quantitative Sirius Red scoring; de novo HLA antibody development and extensive immune monitoring; renal function measured by cGFR and iohexol clearance; CMV and BK infection and other opportunistic infections. DISCUSSION: This study will provide information on the safety of allogeneic MSC infusion and its effect on the incidence of BPAR/graft loss. TRIAL REGISTRATION: NCT02387151. Twit Text FOAVip Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients: the neptune study ????J Transl Med http://www.kidney.de/pget.php?&tw=1&pmid=26537851 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26537851 #FOAvip English Wikipedia <ref>{{Cite pmid|26537851 }}</ref> Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients: the neptune study #MMPMID26537851 Reinders ME ; Dreyer GJ ; Bank JR ; Roelofs H ; Heidt S ; Roelen DL ; Zandvliet ML ; Huurman VA ; Fibbe WE ; van Kooten C ; Claas FH ; Rabelink TJ ; de Fijter JW J Transl Med 2015[Nov]; 13 (ä): 344 PMID26537851 show ga BACKGROUND: Mesenchymal stromal cells (MSC) may serve as an attractive therapy in renal transplantation due to their immunosuppressive and reparative properties. While most studies have used autologous MSCs, allogeneic MSCs offer the advantage of immediate availability for clinical use. This is of major importance for indications where instant treatment is needed, for example allograft rejection or calcineurin inhibitor toxicity. Clinical studies using allogeneic MSCs are limited in number. Although these studies showed no adverse reactions, allogeneic MSCs could possibly elicit an anti-donor immune response, which may increase the incidence of rejection and impact the allograft survival in the long term. These safety issues should be addressed before further studies are planned with allogeneic MSCs in the solid organ transplant setting. METHODS/DESIGN: 10 renal allograft recipients, 18-75 years old, will be included in this clinical phase Ib, open label, single center study. Patients will receive two doses of 1.5 × 10(6) per/kg body weight allogeneic bone marrow derived MSCs intravenously, at 25 and 26 weeks after transplantation, when immune suppression levels are reduced. The primary end point of this study is safety by assessing biopsy proven acute rejection (BPAR)/graft loss after MSC treatment. Secondary end points, all measured before and after MSC infusions, include: comparison of fibrosis in renal biopsy by quantitative Sirius Red scoring; de novo HLA antibody development and extensive immune monitoring; renal function measured by cGFR and iohexol clearance; CMV and BK infection and other opportunistic infections. DISCUSSION: This study will provide information on the safety of allogeneic MSC infusion and its effect on the incidence of BPAR/graft loss. TRIAL REGISTRATION: NCT02387151. |*Kidney Transplantation [MESH] |*Mesenchymal Stem Cell Transplantation [MESH] |Adolescent [MESH] |Adult [MESH] |Aged [MESH] |Biopsy [MESH] |Bone Marrow Cells/*cytology [MESH] |Female [MESH] |Graft Rejection/immunology [MESH] |Graft Survival/immunology [MESH] |Humans [MESH] |Immunosuppressive Agents/therapeutic use [MESH] |Male [MESH] |Mesenchymal Stem Cells/*cytology [MESH] |Middle Aged [MESH] |Prospective Studies [MESH] |Research Design [MESH] |Transplant Recipients [MESH] |Transplantation, Homologous [MESH]Safety of allogeneic bone marrow derived mesenchymal stromal cell ther(epmc).pdf DeepDyve Pubget Overpricing