Subretinal transplantation of human embryonic stem cell-derived retinal pigment epithelium (MA09-hRPE): A safety and tolerability evaluation in minipigs

This study aimed to determine the safety and tolerability of the subretinal injection of hESC-derived RPE cells at higher doses than the established clinical dose (5 × 104 cells/150 μL) by using minipigs. The hESC-derived RPE cells (60 or 120 × 104 cells/150 μL) were injected in subretinal region, and minipigs were sacrificed at Weeks 4, 8, and 12 post-surgery. Time-course examination was performed by using fundus photography, optical coherence tomography (OCT), histopathology, and fluorescence in situ hybridization (FISH). After surgery, retinal bleb and pigmentation were seen and retinal bleb became smaller gradually. In histopathology, cell clusters consisting of a uniform population of the round to oval cells were seen at the subretinal injection site. In immunohistochemistry, most of the cells were positive for anti-CD3 and CD45 antibodies but negative for anti-human nuclei antibody; transplanted cells were not detectable by DNA probe in FISH assay. Cell clusters were thought to be a host immune response to trauma or transplanted cells. There were no other changes related to subretinal RPE cell injection. These results suggested that subretinal injection of hESC-derived RPE cells (60 and 120 × 104 cells/150 μL) in minipigs is well-tolerated and safe.Graphical abstract
Source: Regulatory Toxicology and Pharmacology - Category: Toxicology Source Type: research

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Source: Stem Cell Research - Category: Stem Cells Source Type: research
Authors: PMID: 31110641 [PubMed]
Source: Oman Medical Journal - Category: Middle East Health Tags: Oman Med J Source Type: research
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Source: Molecular Genetics and Metabolism - Category: Genetics & Stem Cells Source Type: research
Conditions:   Acute Leukemia;   CML;   Myelodysplasia;   Lymphoma Interventions:   Procedure: Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate;   Drug: Tacrolimus;   Drug: Methotrexate;   Procedure: Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide;   Drug: Mycophenolate Mofetil;   Drug: Cyclophosphamide Sponsors:   Medical College of Wisconsin;   National Heart, Lung, and Blood Institute (NHLBI);   ...
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Liquid Tumor;   Cancer;   Psychological Feedback Intervention:   Behavioral: GIST Sponsors:   Weill Medical College of Cornell University;   National Cancer Institute (NCI) Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Acute Leukemia;   CML;   Myelodysplasia;   Lymphoma Interventions:   Procedure: Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate;   Drug: Tacrolimus;   Drug: Methotrexate;   Procedure: Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide;   Drug: Mycophenolate Mofetil;   Drug: Cyclophosphamide Sponsors:   Medical College of Wisconsin;   National Heart, Lung, and Blood Institute (NHLBI);   ...
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Liquid Tumor;   Cancer;   Psychological Feedback Intervention:   Behavioral: GIST Sponsors:   Weill Medical College of Cornell University;   National Cancer Institute (NCI) Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
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Source: Ophthalmic Research - Category: Opthalmology Source Type: research
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Source: Cell Reports - Category: Cytology Source Type: research
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Source: EurekAlert! - Biology - Category: Biology Source Type: news
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