Production and nonclinical evaluation of an autologous iPSC–derived platelet product for the iPLAT1 clinical trial
•GMP-based iPSC-platelet production using imMKCL master cells from an aplastic anemia patient with alloimmune transfusion refractoriness.•Extensive nonclinical evaluation confirmed the safety, quality, and efficacy of the patient iPSC-platelet product. [Display omitted] Donor-derived platelets are u...
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Veröffentlicht in: | Blood advances 2022-12, Vol.6 (23), p.6056-6069 |
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creator | Sugimoto, Naoshi Nakamura, Sou Shimizu, Shin Shigemasa, Akiko Kanda, Junya Matsuyama, Nobuki Tanaka, Mitsunobu Hayashi, Tomoya Fuchizaki, Akihiro Nogawa, Masayuki Watanabe, Naohide Okamoto, Shinichiro Handa, Makoto Sawaguchi, Akira Momose, Dai Koh, Ki-Ryang Tani, Yoshihiko Takaori-Kondo, Akifumi Eto, Koji |
description | •GMP-based iPSC-platelet production using imMKCL master cells from an aplastic anemia patient with alloimmune transfusion refractoriness.•Extensive nonclinical evaluation confirmed the safety, quality, and efficacy of the patient iPSC-platelet product.
[Display omitted]
Donor-derived platelets are used to treat or prevent hemorrhage in patients with thrombocytopenia. However, ∼5% or more of these patients are complicated with alloimmune platelet transfusion refractoriness (allo-PTR) due to alloantibodies against HLA-I or human platelet antigens (HPA). In these cases, platelets from compatible donors are necessary, but it is difficult to find such donors for patients with rare HLA-I or HPA. To produce platelet products for patients with aplastic anemia with allo-PTR due to rare HPA-1 mismatch in Japan, we developed an ex vivo good manufacturing process (GMP)–based production system for an induced pluripotent stem cell–derived platelet product (iPSC-PLTs). Immortalized megakaryocyte progenitor cell lines (imMKCLs) were established from patient iPSCs, and a competent imMKCL clone was selected for the master cell bank (MCB) and confirmed for safety, including negativity of pathogens. From this MCB, iPSC-PLTs were produced using turbulent flow bioreactors and new drugs. In extensive nonclinical studies, iPSC-PLTs were confirmed for quality, safety, and efficacy, including hemostasis in a rabbit model. This report presents a complete system for the GMP-based production of iPSC-PLTs and the required nonclinical studies and thus supports the iPLAT1 study, the first-in-human clinical trial of iPSC-PLTs in a patient with allo-PTR and no compatible donor using the autologous product. It also serves as a comprehensive reference for the development of widely applicable allogeneic iPSC-PLTs and other cell products that use iPSC-derived progenitor cells as MCB. |
doi_str_mv | 10.1182/bloodadvances.2022008512 |
format | Article |
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[Display omitted]
Donor-derived platelets are used to treat or prevent hemorrhage in patients with thrombocytopenia. However, ∼5% or more of these patients are complicated with alloimmune platelet transfusion refractoriness (allo-PTR) due to alloantibodies against HLA-I or human platelet antigens (HPA). In these cases, platelets from compatible donors are necessary, but it is difficult to find such donors for patients with rare HLA-I or HPA. To produce platelet products for patients with aplastic anemia with allo-PTR due to rare HPA-1 mismatch in Japan, we developed an ex vivo good manufacturing process (GMP)–based production system for an induced pluripotent stem cell–derived platelet product (iPSC-PLTs). Immortalized megakaryocyte progenitor cell lines (imMKCLs) were established from patient iPSCs, and a competent imMKCL clone was selected for the master cell bank (MCB) and confirmed for safety, including negativity of pathogens. From this MCB, iPSC-PLTs were produced using turbulent flow bioreactors and new drugs. In extensive nonclinical studies, iPSC-PLTs were confirmed for quality, safety, and efficacy, including hemostasis in a rabbit model. This report presents a complete system for the GMP-based production of iPSC-PLTs and the required nonclinical studies and thus supports the iPLAT1 study, the first-in-human clinical trial of iPSC-PLTs in a patient with allo-PTR and no compatible donor using the autologous product. It also serves as a comprehensive reference for the development of widely applicable allogeneic iPSC-PLTs and other cell products that use iPSC-derived progenitor cells as MCB.</description><identifier>ISSN: 2473-9529</identifier><identifier>EISSN: 2473-9537</identifier><identifier>DOI: 10.1182/bloodadvances.2022008512</identifier><identifier>PMID: 36149941</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Animals ; Antigens, Human Platelet ; Blood Platelets - metabolism ; Hematopoietic Stem Cell Transplantation - adverse effects ; Humans ; Induced Pluripotent Stem Cells - metabolism ; Platelet Transfusion - adverse effects ; Rabbits ; Regular ; Thrombocytopenia - etiology</subject><ispartof>Blood advances, 2022-12, Vol.6 (23), p.6056-6069</ispartof><rights>2022 The American Society of Hematology</rights><rights>2022 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.</rights><rights>2022 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved. 2022 The American Society of Hematology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c589t-9f456f9161c3642842d1d18df0a7b78e27d533f544e6789e90f1954d8b90ef7b3</citedby><cites>FETCH-LOGICAL-c589t-9f456f9161c3642842d1d18df0a7b78e27d533f544e6789e90f1954d8b90ef7b3</cites><orcidid>0000-0002-1776-0052 ; 0000-0002-5863-7122 ; 0000-0002-5601-9777 ; 0000-0002-4835-2545 ; 0000-0002-9024-6818 ; 0000-0001-7678-4284 ; 0000-0002-7271-9175 ; 0000-0002-6257-4152 ; 0000-0002-6704-3633 ; 0000-0003-3387-1817</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9706535/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9706535/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36149941$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sugimoto, Naoshi</creatorcontrib><creatorcontrib>Nakamura, Sou</creatorcontrib><creatorcontrib>Shimizu, Shin</creatorcontrib><creatorcontrib>Shigemasa, Akiko</creatorcontrib><creatorcontrib>Kanda, Junya</creatorcontrib><creatorcontrib>Matsuyama, Nobuki</creatorcontrib><creatorcontrib>Tanaka, Mitsunobu</creatorcontrib><creatorcontrib>Hayashi, Tomoya</creatorcontrib><creatorcontrib>Fuchizaki, Akihiro</creatorcontrib><creatorcontrib>Nogawa, Masayuki</creatorcontrib><creatorcontrib>Watanabe, Naohide</creatorcontrib><creatorcontrib>Okamoto, Shinichiro</creatorcontrib><creatorcontrib>Handa, Makoto</creatorcontrib><creatorcontrib>Sawaguchi, Akira</creatorcontrib><creatorcontrib>Momose, Dai</creatorcontrib><creatorcontrib>Koh, Ki-Ryang</creatorcontrib><creatorcontrib>Tani, Yoshihiko</creatorcontrib><creatorcontrib>Takaori-Kondo, Akifumi</creatorcontrib><creatorcontrib>Eto, Koji</creatorcontrib><title>Production and nonclinical evaluation of an autologous iPSC–derived platelet product for the iPLAT1 clinical trial</title><title>Blood advances</title><addtitle>Blood Adv</addtitle><description>•GMP-based iPSC-platelet production using imMKCL master cells from an aplastic anemia patient with alloimmune transfusion refractoriness.•Extensive nonclinical evaluation confirmed the safety, quality, and efficacy of the patient iPSC-platelet product.
[Display omitted]
Donor-derived platelets are used to treat or prevent hemorrhage in patients with thrombocytopenia. However, ∼5% or more of these patients are complicated with alloimmune platelet transfusion refractoriness (allo-PTR) due to alloantibodies against HLA-I or human platelet antigens (HPA). In these cases, platelets from compatible donors are necessary, but it is difficult to find such donors for patients with rare HLA-I or HPA. To produce platelet products for patients with aplastic anemia with allo-PTR due to rare HPA-1 mismatch in Japan, we developed an ex vivo good manufacturing process (GMP)–based production system for an induced pluripotent stem cell–derived platelet product (iPSC-PLTs). Immortalized megakaryocyte progenitor cell lines (imMKCLs) were established from patient iPSCs, and a competent imMKCL clone was selected for the master cell bank (MCB) and confirmed for safety, including negativity of pathogens. From this MCB, iPSC-PLTs were produced using turbulent flow bioreactors and new drugs. In extensive nonclinical studies, iPSC-PLTs were confirmed for quality, safety, and efficacy, including hemostasis in a rabbit model. This report presents a complete system for the GMP-based production of iPSC-PLTs and the required nonclinical studies and thus supports the iPLAT1 study, the first-in-human clinical trial of iPSC-PLTs in a patient with allo-PTR and no compatible donor using the autologous product. It also serves as a comprehensive reference for the development of widely applicable allogeneic iPSC-PLTs and other cell products that use iPSC-derived progenitor cells as MCB.</description><subject>Animals</subject><subject>Antigens, Human Platelet</subject><subject>Blood Platelets - metabolism</subject><subject>Hematopoietic Stem Cell Transplantation - adverse effects</subject><subject>Humans</subject><subject>Induced Pluripotent Stem Cells - metabolism</subject><subject>Platelet Transfusion - adverse effects</subject><subject>Rabbits</subject><subject>Regular</subject><subject>Thrombocytopenia - etiology</subject><issn>2473-9529</issn><issn>2473-9537</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc9uFSEUxifGxjZtX8GwdHMrMDDAxqTe-C-5iU2sa8LAocVwhyswk3TnO_QN-ySit17tyhUk33d-5-T7ug4RfEGIpK_HmJIzbjGThXJBMaUYS07os-6EMtGvFO_F88OfquPuvJRvGGMihp4r-qI77gfClGLkpKtXObnZ1pAmZCaHpjTZGKZgTUSwmDib31LyTUVmrimmmzQXFK6-rB9-3DvIYQGHdtFUiFDRbo9DPmVUb6H5NpfXBB2YNQcTz7ojb2KB88f3tPv6_t31-uNq8_nDp_XlZmW5VHWlPOODV2Qgth8YlYw64oh0HhsxCglUON73njMGg5AKFPZEcebkqDB4Mfan3Zs9dzePW3AWpppN1Lsctibf6WSCfqpM4VbfpEUrgQfe8wZ49QjI6fsMpeptKBZiNBO0FDQVLVMlyCCaVe6tNqdSMvjDGoL1r970k970397a6Mt_zzwM_mmpGd7uDdDCWgJkXWyAhnEhg63apfD_LT8B1VKyGw</recordid><startdate>20221213</startdate><enddate>20221213</enddate><creator>Sugimoto, Naoshi</creator><creator>Nakamura, Sou</creator><creator>Shimizu, Shin</creator><creator>Shigemasa, Akiko</creator><creator>Kanda, Junya</creator><creator>Matsuyama, Nobuki</creator><creator>Tanaka, Mitsunobu</creator><creator>Hayashi, Tomoya</creator><creator>Fuchizaki, Akihiro</creator><creator>Nogawa, Masayuki</creator><creator>Watanabe, Naohide</creator><creator>Okamoto, Shinichiro</creator><creator>Handa, Makoto</creator><creator>Sawaguchi, Akira</creator><creator>Momose, Dai</creator><creator>Koh, Ki-Ryang</creator><creator>Tani, Yoshihiko</creator><creator>Takaori-Kondo, Akifumi</creator><creator>Eto, Koji</creator><general>Elsevier Inc</general><general>The American Society of Hematology</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-1776-0052</orcidid><orcidid>https://orcid.org/0000-0002-5863-7122</orcidid><orcidid>https://orcid.org/0000-0002-5601-9777</orcidid><orcidid>https://orcid.org/0000-0002-4835-2545</orcidid><orcidid>https://orcid.org/0000-0002-9024-6818</orcidid><orcidid>https://orcid.org/0000-0001-7678-4284</orcidid><orcidid>https://orcid.org/0000-0002-7271-9175</orcidid><orcidid>https://orcid.org/0000-0002-6257-4152</orcidid><orcidid>https://orcid.org/0000-0002-6704-3633</orcidid><orcidid>https://orcid.org/0000-0003-3387-1817</orcidid></search><sort><creationdate>20221213</creationdate><title>Production and nonclinical evaluation of an autologous iPSC–derived platelet product for the iPLAT1 clinical trial</title><author>Sugimoto, Naoshi ; Nakamura, Sou ; Shimizu, Shin ; Shigemasa, Akiko ; Kanda, Junya ; Matsuyama, Nobuki ; Tanaka, Mitsunobu ; Hayashi, Tomoya ; Fuchizaki, Akihiro ; Nogawa, Masayuki ; Watanabe, Naohide ; Okamoto, Shinichiro ; Handa, Makoto ; Sawaguchi, Akira ; Momose, Dai ; Koh, Ki-Ryang ; Tani, Yoshihiko ; Takaori-Kondo, Akifumi ; Eto, Koji</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c589t-9f456f9161c3642842d1d18df0a7b78e27d533f544e6789e90f1954d8b90ef7b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Animals</topic><topic>Antigens, Human Platelet</topic><topic>Blood Platelets - metabolism</topic><topic>Hematopoietic Stem Cell Transplantation - adverse effects</topic><topic>Humans</topic><topic>Induced Pluripotent Stem Cells - metabolism</topic><topic>Platelet Transfusion - adverse effects</topic><topic>Rabbits</topic><topic>Regular</topic><topic>Thrombocytopenia - etiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sugimoto, Naoshi</creatorcontrib><creatorcontrib>Nakamura, Sou</creatorcontrib><creatorcontrib>Shimizu, Shin</creatorcontrib><creatorcontrib>Shigemasa, Akiko</creatorcontrib><creatorcontrib>Kanda, Junya</creatorcontrib><creatorcontrib>Matsuyama, Nobuki</creatorcontrib><creatorcontrib>Tanaka, Mitsunobu</creatorcontrib><creatorcontrib>Hayashi, Tomoya</creatorcontrib><creatorcontrib>Fuchizaki, Akihiro</creatorcontrib><creatorcontrib>Nogawa, Masayuki</creatorcontrib><creatorcontrib>Watanabe, Naohide</creatorcontrib><creatorcontrib>Okamoto, Shinichiro</creatorcontrib><creatorcontrib>Handa, Makoto</creatorcontrib><creatorcontrib>Sawaguchi, Akira</creatorcontrib><creatorcontrib>Momose, Dai</creatorcontrib><creatorcontrib>Koh, Ki-Ryang</creatorcontrib><creatorcontrib>Tani, Yoshihiko</creatorcontrib><creatorcontrib>Takaori-Kondo, Akifumi</creatorcontrib><creatorcontrib>Eto, Koji</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Blood advances</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sugimoto, Naoshi</au><au>Nakamura, Sou</au><au>Shimizu, Shin</au><au>Shigemasa, Akiko</au><au>Kanda, Junya</au><au>Matsuyama, Nobuki</au><au>Tanaka, Mitsunobu</au><au>Hayashi, Tomoya</au><au>Fuchizaki, Akihiro</au><au>Nogawa, Masayuki</au><au>Watanabe, Naohide</au><au>Okamoto, Shinichiro</au><au>Handa, Makoto</au><au>Sawaguchi, Akira</au><au>Momose, Dai</au><au>Koh, Ki-Ryang</au><au>Tani, Yoshihiko</au><au>Takaori-Kondo, Akifumi</au><au>Eto, Koji</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Production and nonclinical evaluation of an autologous iPSC–derived platelet product for the iPLAT1 clinical trial</atitle><jtitle>Blood advances</jtitle><addtitle>Blood Adv</addtitle><date>2022-12-13</date><risdate>2022</risdate><volume>6</volume><issue>23</issue><spage>6056</spage><epage>6069</epage><pages>6056-6069</pages><issn>2473-9529</issn><eissn>2473-9537</eissn><abstract>•GMP-based iPSC-platelet production using imMKCL master cells from an aplastic anemia patient with alloimmune transfusion refractoriness.•Extensive nonclinical evaluation confirmed the safety, quality, and efficacy of the patient iPSC-platelet product.
[Display omitted]
Donor-derived platelets are used to treat or prevent hemorrhage in patients with thrombocytopenia. However, ∼5% or more of these patients are complicated with alloimmune platelet transfusion refractoriness (allo-PTR) due to alloantibodies against HLA-I or human platelet antigens (HPA). In these cases, platelets from compatible donors are necessary, but it is difficult to find such donors for patients with rare HLA-I or HPA. To produce platelet products for patients with aplastic anemia with allo-PTR due to rare HPA-1 mismatch in Japan, we developed an ex vivo good manufacturing process (GMP)–based production system for an induced pluripotent stem cell–derived platelet product (iPSC-PLTs). Immortalized megakaryocyte progenitor cell lines (imMKCLs) were established from patient iPSCs, and a competent imMKCL clone was selected for the master cell bank (MCB) and confirmed for safety, including negativity of pathogens. From this MCB, iPSC-PLTs were produced using turbulent flow bioreactors and new drugs. In extensive nonclinical studies, iPSC-PLTs were confirmed for quality, safety, and efficacy, including hemostasis in a rabbit model. This report presents a complete system for the GMP-based production of iPSC-PLTs and the required nonclinical studies and thus supports the iPLAT1 study, the first-in-human clinical trial of iPSC-PLTs in a patient with allo-PTR and no compatible donor using the autologous product. It also serves as a comprehensive reference for the development of widely applicable allogeneic iPSC-PLTs and other cell products that use iPSC-derived progenitor cells as MCB.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36149941</pmid><doi>10.1182/bloodadvances.2022008512</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0002-1776-0052</orcidid><orcidid>https://orcid.org/0000-0002-5863-7122</orcidid><orcidid>https://orcid.org/0000-0002-5601-9777</orcidid><orcidid>https://orcid.org/0000-0002-4835-2545</orcidid><orcidid>https://orcid.org/0000-0002-9024-6818</orcidid><orcidid>https://orcid.org/0000-0001-7678-4284</orcidid><orcidid>https://orcid.org/0000-0002-7271-9175</orcidid><orcidid>https://orcid.org/0000-0002-6257-4152</orcidid><orcidid>https://orcid.org/0000-0002-6704-3633</orcidid><orcidid>https://orcid.org/0000-0003-3387-1817</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Animals Antigens, Human Platelet Blood Platelets - metabolism Hematopoietic Stem Cell Transplantation - adverse effects Humans Induced Pluripotent Stem Cells - metabolism Platelet Transfusion - adverse effects Rabbits Regular Thrombocytopenia - etiology |
title | Production and nonclinical evaluation of an autologous iPSC–derived platelet product for the iPLAT1 clinical trial |
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