669e8caf15393eb561ca345893e3b0a5 pmc_32304998.pdf b283f60311c66ef1a79eec3f63445f14e297e7c6 pmc_32304998.pdf 9752247dbbfcef1b48d08008e3f7b295c119cfa0e4a754e09a4c0bec70b5ba82 pmc_32304998.pdf Title: First-in-human PeriCord cardiac bioimplant: Scalability and GMP manufacturing of an allogeneic engineered tissue graft Subject: EBioMedicine, 54 () . doi:10.1016/j.ebiom.2020.102729 Keywords: Wharton's jelly-derived mesenchymal stromal cells (WJ-MSCs); Biofabrication; Advanced therapy medicinal product (ATMP); Cardiac tissue engineering; Scaffold; Myocardial infarction Author: Cristina Prat-Vidal Creator: Elsevier Producer: Acrobat Distiller 10.1.10 (Windows) CreationDate: Wed Apr 15 13:56:25 2020 CEST ModDate: Wed Apr 15 13:56:59 2020 CEST Tagged: yes UserProperties: no Suspects: no Form: none JavaScript: no Pages: 11 Encrypted: no Page size: 595.276 x 793.701 pts Page rot: 0 File size: 2421157 bytes Optimized: yes PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- LPABCI+AdvOT5fa4e291+20 Type 1C WinAnsi yes yes no 424 0 LPABCG+AdvOT5fa4e291+fb Type 1C Custom yes yes yes 427 0 LPABCE+AdvOTf2586c63+fb Type 1C Custom yes yes yes 432 0 LPAHOO+AdvPAC3D Type 1C WinAnsi yes yes no 437 0 LPABCF+AdvOTf2586c63+20 Type 1C WinAnsi yes yes no 440 0 LPAALD+AdvOT5fa4e291 Type 1C WinAnsi yes yes no 443 0 LPABCD+AdvOTf2586c63 Type 1C WinAnsi yes yes no 446 0 LPABCH+AdvP4C4E74 Type 1C Custom yes yes no 449 0 LPABCK+AdvP4C9542 Type 1C WinAnsi yes yes no 453 0 LPABCJ+AdvP4C9543 Type 1C Custom yes yes yes 456 0 LPABBC+AdvP4C4E59 Type 1C Custom yes yes yes 461 0 LPAIOJ+AdvTTb83ee1dd.B Type 1C WinAnsi yes yes no 272 0 LPAOAI+AdvP697C Type 1C Custom yes yes no 275 0 LPBJLM+AdvP4A5FDB Type 1C WinAnsi yes yes no 279 0 LPBJLN+AdvTTb83ee1dd.B+fb Type 1C Custom yes yes yes 58 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2020-11-18 06:45:13 CET RepresentationInformation: pmc_32304998.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2020-07-06 03:49:24 CEST Size: 2421157 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf Profile: Linearized PDF PDFMetadata: Objects: 580 FreeObjects: 1 IncrementalUpdates: 1 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: false CenterWindow: false DisplayDocTitle: true NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseOutlines Outlines: Item: Title: First-in-human PeriCord cardiac bioimplant: Scalability and GMP manufacturing of an allogeneic engineered tissue graft Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1060b431 Children: Item: Title: 1. Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@612679d6 Item: Title: 2. Materials and methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@11758f2a Children: Item: Title: 2.1. Rational of the study Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@e720b71 Item: Title: 2.2. Investigational medicinal product: the PeriCord Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1b26f7b2 Children: Item: Title: 2.2.1. Active ingredient: clinical-grade WJ-MSCs Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@491cc5c9 Item: Title: 2.2.2. Vehicle: decellularised, lyophilised and sterilised human pericardium Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@74ad1f1f Item: Title: 2.2.3. PeriCord manufacturing Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@6a1aab78 Item: Title: 2.3. PeriCord first-in-human surgical implantation Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@462d5aee Item: Title: 2.4. Cardiac magnetic resonance imaging data acquisition and analysis Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@69b0fd6f Item: Title: 2.5. Statistical analysis Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@757942a1 Item: Title: 3. Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4a87761d Children: Item: Title: 3.1. Clinical-grade WJ-MSC production Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@66d1af89 Item: Title: 3.2. Decellularised pericardial matrix processing Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@8646db9 Item: Title: 3.3. PeriCord cardiac bioimplant: scale-up and manufacturing process Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@37374a5e Item: Title: 3.4. PeriCord cardiac bioimplant: first-in-human patient implantation Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4671e53b Item: Title: 4. Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@2db7a79b Item: Title: Declarations of Competing Interest Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@6950e31 Children: Item: Title: Acknowledgements Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@b7dd107 Item: Title: Funding sources Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@42eca56e Item: Title: Author contributions Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@52f759d7 Item: Title: Supplementary materials Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7cbd213e Children: Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@192d3247 Info: Title: First-in-human PeriCord cardiac bioimplant: Scalability and GMP manufacturing of an allogeneic engineered tissue graft Author: Cristina Prat-Vidal Subject: EBioMedicine, 54 () . doi:10.1016/j.ebiom.2020.102729 Keywords: Wharton's 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EBioMedicine, 54 () . doi:10.1016/j.ebiom.2020.102729 Wharton's jelly-derived mesenchymal stromal cells (WJ-MSCs) Biofabrication Advanced therapy medicinal product (ATMP) Cardiac tissue engineering Scaffold Myocardial infarction First-in-human PeriCord cardiac bioimplant: Scalability and GMP manufacturing of an allogeneic engineered tissue graft Cristina Prat-Vidal Luciano Rodríguez-Gómez Miriam Aylagas Nuria Nieto-Nicolau Paloma Gastelurrutia Elba Agustí Carolina Gálvez-Montón Ignasi Jorba Albert Teis Marta Monguió-Tortajada Santiago Roura Joaquim Vives Silvia Torrents-Zapata María Isabel Coca Laura Reales María Luisa Cámara-Rosell Germán Cediel Ruth Coll Ramon Farré Daniel Navajas Anna Vilarrodona Joan García-López Christian Muñoz-Guijosa Sergi Querol Antoni Bayes-Genis uuid:fd8cfc10-4791-4a8b-8025-00abb91efa0c uuid:2c0817c1-5ba3-4a0e-86ec-96764cc47d5e journal © 2020 The Authors. Published by Elsevier B.V. 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57, 273, 293, 279 Annotation: Subtype: Link Rect: 57, 265, 252, 271 Annotation: Subtype: Link Rect: 57, 257, 293, 263 Annotation: Subtype: Link Rect: 57, 249, 293, 255 Annotation: Subtype: Link Rect: 57, 241, 244, 247 Annotation: Subtype: Link Rect: 57, 233, 103, 239 Annotation: Subtype: Link Rect: 106, 233, 136, 239 Annotation: Subtype: Link Rect: 139, 233, 293, 239 Annotation: Subtype: Link Rect: 57, 225, 273, 231 Annotation: Subtype: Link Rect: 326, 727, 331, 733 Annotation: Subtype: Link Rect: 334, 727, 364, 733 Annotation: Subtype: Link Rect: 368, 727, 395, 733 Annotation: Subtype: Link Rect: 398, 727, 562, 733 Annotation: Subtype: Link Rect: 326, 719, 562, 725 Annotation: Subtype: Link Rect: 326, 711, 488, 717 Annotation: Subtype: Link Rect: 326, 703, 364, 709 Annotation: Subtype: Link Rect: 367, 703, 397, 709 Annotation: Subtype: Link Rect: 401, 703, 562, 709 Annotation: Subtype: Link Rect: 326, 695, 562, 701 Annotation: Subtype: Link Rect: 326, 687, 445, 693 Annotation: Subtype: Link Rect: 326, 679, 562, 686 Annotation: Subtype: Link Rect: 326, 671, 562, 678 Annotation: Subtype: Link Rect: 326, 663, 425, 670 Annotation: Subtype: Link Rect: 326, 655, 562, 662 Annotation: Subtype: Link Rect: 326, 647, 562, 654 Annotation: Subtype: Link Rect: 326, 639, 438, 646 Annotation: Subtype: Link Rect: 326, 631, 562, 638 Annotation: Subtype: Link Rect: 326, 623, 562, 630 Annotation: Subtype: Link Rect: 326, 615, 562, 622 Annotation: Subtype: Link Rect: 326, 607, 396, 614 Annotation: Subtype: Link Rect: 326, 599, 562, 606 Annotation: Subtype: Link Rect: 326, 591, 521, 598 Annotation: Subtype: Link Rect: 326, 583, 562, 590 Annotation: Subtype: Link Rect: 326, 576, 562, 582 Annotation: Subtype: Link Rect: 326, 568, 562, 574 Annotation: Subtype: Link Rect: 326, 560, 562, 566 Annotation: Subtype: Link Rect: 326, 552, 465, 558 Annotation: Subtype: Link Rect: 326, 544, 562, 550 Annotation: Subtype: Link Rect: 326, 536, 562, 542 Annotation: Subtype: Link Rect: 326, 528, 562, 534 Annotation: Subtype: Link Rect: 326, 520, 522, 526 Annotation: Subtype: Link Rect: 326, 512, 562, 518 Annotation: Subtype: Link Rect: 326, 504, 562, 510 Annotation: Subtype: Link Rect: 326, 496, 447, 502 Annotation: Subtype: Link Rect: 326, 488, 562, 494 Annotation: Subtype: Link Rect: 326, 480, 562, 486 Annotation: Subtype: Link Rect: 326, 472, 417, 478 Annotation: Subtype: Link Rect: 326, 464, 562, 470 Annotation: Subtype: Link Rect: 326, 456, 483, 462 Annotation: Subtype: Link Rect: 326, 448, 562, 454 Annotation: Subtype: Link Rect: 326, 440, 562, 446 Annotation: Subtype: Link Rect: 326, 432, 376, 438 Annotation: Subtype: Link Rect: 326, 424, 352, 430 Annotation: Subtype: Link Rect: 356, 424, 416, 430 Annotation: Subtype: Link Rect: 419, 424, 562, 430 Annotation: Subtype: Link Rect: 326, 416, 562, 422 Annotation: Subtype: Link Rect: 326, 408, 409, 415 Annotation: Subtype: Link Rect: 326, 400, 352, 407 Annotation: Subtype: Link Rect: 356, 400, 415, 407 Annotation: Subtype: Link Rect: 419, 400, 562, 407 Annotation: Subtype: Link Rect: 326, 392, 562, 399 Annotation: Subtype: Link Rect: 326, 384, 463, 391 Annotation: Subtype: Link Rect: 326, 376, 562, 383 Annotation: Subtype: Link Rect: 326, 368, 439, 375 Annotation: Subtype: Link Rect: 326, 360, 562, 367 Annotation: Subtype: Link Rect: 326, 352, 562, 359 Annotation: Subtype: Link Rect: 326, 344, 478, 351 Annotation: Subtype: Link Rect: 326, 336, 562, 343 Annotation: Subtype: Link Rect: 326, 328, 562, 335 Annotation: Subtype: Link Rect: 326, 320, 408, 327 Annotation: Subtype: Link Rect: 326, 313, 562, 319 Annotation: Subtype: Link Rect: 326, 305, 562, 311 Annotation: Subtype: Link Rect: 326, 297, 417, 303 Annotation: Subtype: Link Rect: 326, 289, 562, 295 Annotation: Subtype: Link Rect: 326, 281, 562, 287 Annotation: Subtype: Link Rect: 326, 273, 392, 279 Annotation: Subtype: Link Rect: 326, 265, 562, 271 Annotation: Subtype: Link Rect: 326, 257, 562, 263 Annotation: Subtype: Link Rect: 326, 249, 376, 255 Annotation: Subtype: Link Rect: 326, 241, 562, 247 Annotation: Subtype: Link Rect: 326, 233, 562, 239 Annotation: Subtype: Link Rect: 326, 225, 535, 231 Checksum: d94e5fd5 Type: CRC32 Checksum: 669e8caf15393eb561ca345893e3b0a5 Type: MD5 Checksum: b283f60311c66ef1a79eec3f63445f14e297e7c6 Type: SHA-1