INDEX OF TABLES - BioInformant | Your Global Leader in ...



TABLE OF CONTENTS TOC \o "4-4" \h \z \t "Heading 1,1,Heading 2,2,Heading 3,3" 1. REPORT OVERVIEW PAGEREF _Toc61009258 \h 161.1Statement of the Report PAGEREF _Toc61009259 \h 171.2Target Demographic PAGEREF _Toc61009260 \h 191.3Report Sources PAGEREF _Toc61009261 \h 191.4Purpose of the Report PAGEREF _Toc61009262 \h 201.4.1 To Survey Recent MSC Advancements PAGEREF _Toc61009263 \h 201.4.2 To Provide a “Snapshot” of Global MSC Market PAGEREF _Toc61009264 \h 201.4.3 To Assess Opportunities for Commercialization PAGEREF _Toc61009265 \h 211.4.4 To Identify Major Market Players and Assess the Competitive Environment PAGEREF _Toc61009266 \h 211.4.5 To Identify Existing and Emerging Trends PAGEREF _Toc61009267 \h 211.4.6 To Identify Critical Opportunities and Threats within the MSC Market PAGEREF _Toc61009268 \h 221.5Executive Summary PAGEREF _Toc61009269 \h 221.6Introduction PAGEREF _Toc61009270 \h 242.MESECHYMAL STEM CELLS (MSCS): AN OVERVIEW PAGEREF _Toc61009271 \h 262.1The Impact of MSCs on Regenerative Medicine PAGEREF _Toc61009272 \h 262.2Timeline of MSC Nomenclature PAGEREF _Toc61009273 \h 272.3Sources of MSCs PAGEREF _Toc61009274 \h 272.3.1 Bone Marrow-Derived MSCs (BM-MSCs) PAGEREF _Toc61009275 \h 282.3.2 Adipose-Derived MSCs (AD-MSCs) PAGEREF _Toc61009276 \h 292.3.3 Umbilical Cord-Derived MSCs (UC-MSCs) PAGEREF _Toc61009277 \h 292.4Cell Surface Markers in MSCs PAGEREF _Toc61009278 \h 302.5In Vitro Differentiation Potentials of MSCs PAGEREF _Toc61009279 \h 312.6Soluble Factors Secreted by MSCs PAGEREF _Toc61009280 \h 323.MANUFACTURE OF MESENCHYMAL STEM CELLS PAGEREF _Toc61009281 \h 343.1Methods of Isolation of MSCs PAGEREF _Toc61009282 \h 353.2From Conventional Cultures to Bioreactors PAGEREF _Toc61009283 \h 363.2.1 Monolayer Culture Systems PAGEREF _Toc61009284 \h 363.2.2 Bioreactor-Based Cell Expansion PAGEREF _Toc61009285 \h 373.2.3 Stirred Tank Bioreactor PAGEREF _Toc61009286 \h 373.2.4 Rocking Bioreactor PAGEREF _Toc61009287 \h 383.2.5 Hollow Fiber Bioreactors PAGEREF _Toc61009288 \h 383.2.6 Fixed-Bed Bioreactors PAGEREF _Toc61009289 \h 393.3Main Features of Commercial Bioreactors PAGEREF _Toc61009290 \h 443.4Microcarriers used for the Expansion of MSCs PAGEREF _Toc61009291 \h 463.5Downstream Processing of MSCs PAGEREF _Toc61009292 \h 483.5.1 Cell Detachment and Separation PAGEREF _Toc61009293 \h 483.5.2 Cell Washing and Concentration PAGEREF _Toc61009294 \h 503.5.3 Safety and Potency Assays PAGEREF _Toc61009295 \h 503.5.4 Surface Markers for Identification during MSC Manufacture PAGEREF _Toc61009296 \h PARISON OF AUTOLOGOUS AND ALLOGENEIC MSC MANUFACTURE PAGEREF _Toc61009297 \h 524.1Manufacturing Cost Compared PAGEREF _Toc61009298 \h 524.1.1 Cost Differential PAGEREF _Toc61009299 \h 534.1.2 Cost of Donor Screening and Testing PAGEREF _Toc61009300 \h 534.1.3 Cost for Release Testing PAGEREF _Toc61009301 \h 544.2Comparison of the Two Business Models PAGEREF _Toc61009302 \h 544.2.1Risk of Immune Reaction PAGEREF _Toc61009303 \h 544.2.2 Risk of Cross Contamination PAGEREF _Toc61009304 \h 554.2.3 Commercially Attractive Option PAGEREF _Toc61009305 \h 554.3Cost Breakdown in MSC Manufacturing PAGEREF _Toc61009306 \h 554.4Opportunities for Cost Reduction PAGEREF _Toc61009307 \h 574.5Partial Automation vs. Full Automation PAGEREF _Toc61009308 \h 584.5.1 Partial Automation: The Most Attractive Option PAGEREF _Toc61009309 \h 605.SMALL SCALE PROCESSING OF MSCS PAGEREF _Toc61009310 \h 615.1Model Design PAGEREF _Toc61009311 \h 615.2Culture Media PAGEREF _Toc61009312 \h 626.LARGE-SCALE EXPANSION OF MSCS PAGEREF _Toc61009313 \h 676.1The Four Common Bioprocessing Strategies for Large-Scale Expansion PAGEREF _Toc61009314 \h 686.2Commonly Used Sources of MSCs for Large-Scale Expansion PAGEREF _Toc61009315 \h 696.3The Commonly Used Culture Medium for the Large-Scale Expansion of MSCs PAGEREF _Toc61009316 \h 706.3.1 Expansion Ratio Achieved with Different Culture Media PAGEREF _Toc61009317 \h 706.4Comparison between Large-Scale Bioprocessing Strategies PAGEREF _Toc61009318 \h 726.5Contract Manufacturing for Cell Therapies PAGEREF _Toc61009319 \h 726.5.1 Contract Manufacturing Organizations (CMOs) PAGEREF _Toc61009320 \h 736.5.2 Contract Development and Manufacturing Organizations (CDMOs) PAGEREF _Toc61009321 \h 736.5.2.1 Major Services Offered by CMOs PAGEREF _Toc61009322 \h 736.5.2.2 Regional Distribution of CMOs PAGEREF _Toc61009323 \h 746.6Global Cell Therapy Manufacturing Capacity PAGEREF _Toc61009324 \h 756.6.1 Major Cell Therapy CMOs/CDMOs in the U.S PAGEREF _Toc61009325 \h 766.6.2 Major CMOs/CDMOs for Cell Therapy Manufacturing in Europe PAGEREF _Toc61009326 \h 777.ESTIMATED CONSUMPTION OF MSCS IN THE INDUSTRY PAGEREF _Toc61009327 \h 787.1Consumption of MSCs in Academic and Preclinical Settings PAGEREF _Toc61009328 \h 797.2MSC Consumption in Clinical Settings PAGEREF _Toc61009329 \h 797.3Consumption of MSCs by Target Indications in Clinical Trials PAGEREF _Toc61009330 \h 807.4Future Consumption through 2030 PAGEREF _Toc61009331 \h 817.4.1 Consumption for MSC Therapeutics PAGEREF _Toc61009332 \h 817.4.2 Consumption for Engineered Tissues and Organs PAGEREF _Toc61009333 \h 817.4.3 MSC Consumption by MSC-Derived Products PAGEREF _Toc61009334 \h 827.4.4 MSC Consumption in Emerging Industries PAGEREF _Toc61009335 \h 827.5Cost of MSCs per Patient used in Clinical Trials by Indication PAGEREF _Toc61009336 \h 828.PUBLISHED SCIENTIFIC PAPERS ON MSCS PAGEREF _Toc61009337 \h 848.1Number of Papers on MSCs & iPSCs Compared PAGEREF _Toc61009338 \h 858.2Number of Papers on MSCs by Source PAGEREF _Toc61009339 \h 878.3Number of Papers Published on Clinical Trials Involving MSCs PAGEREF _Toc61009340 \h 888.3.1 Number of Papers on Clinical Trials using MSCs for Specific Diseases PAGEREF _Toc61009341 \h 899.CLINICAL TRIALS OF MSCS, MSC-BASED COVID-19, MSC-EXOSOMES PAGEREF _Toc61009342 \h 919.1Analysis of Data from PAGEREF _Toc61009343 \h 919.2Sources of MSCs for Clinical Trials PAGEREF _Toc61009344 \h 929.3Autologous vs. Allogeneic MSCs PAGEREF _Toc61009345 \h 939.4Regional Distribution of MSC-Based Clinical Trials PAGEREF _Toc61009346 \h 949.4.1 Major Countries Involved in MSC-Based Clinical Trials PAGEREF _Toc61009347 \h 959.5Types of Funding for MSC-Based Clinical Trials PAGEREF _Toc61009348 \h 979.6Types of MSC-Based Clinical Trials PAGEREF _Toc61009349 \h 989.7MSC-Based Clinical Trials by Phase of Development PAGEREF _Toc61009350 \h 999.8Clinical Trials Involving MSCs for the Treatment of COVID-19 PAGEREF _Toc61009351 \h 1009.8.1 MSC-Based COVID-19 Clinical Trials by Geography PAGEREF _Toc61009352 \h 1009.9Clinical Trials Involving MSC-Derived Exosomes PAGEREF _Toc61009353 \h 1029.10NIH Funding for MSC Research PAGEREF _Toc61009354 \h 1039.11CIRM’s Funding for MSC Projects PAGEREF _Toc61009355 \h 1059.11.1 CIRM Funding for MSC-Based Clinical Trials PAGEREF _Toc61009356 \h 10610.CURRENT SUB-OPTIMAL CLINICAL OUTCOMES & SOLUTIONS PAGEREF _Toc61009357 \h 10710.1To Overcome Challenges Arising from MSC Manufacture PAGEREF _Toc61009358 \h 10710.1.1 Heterogeneity in the MSC Product PAGEREF _Toc61009359 \h 10710.2Cryopreservation and Culture Rescue PAGEREF _Toc61009360 \h 10910.2.1 Bioengineering Solutions to Boost MSC Function PAGEREF _Toc61009361 \h 10910.2.2 Engineering MSCs to Carry Anti-Cancer “Trogan Horses” PAGEREF _Toc61009362 \h 11110.3Overcoming Clinical Challenges Related to Infusion PAGEREF _Toc61009363 \h 11210.3.1 Local Administration PAGEREF _Toc61009364 \h 11210.3.2 Insufficient Retention and Survival PAGEREF _Toc61009365 \h 11210.3.3 Strategies to Improve Local Administration PAGEREF _Toc61009366 \h 11210.4To Overcome Clinical Challenges from the Host PAGEREF _Toc61009367 \h 11311.MODIFICATION OF MSCS PAGEREF _Toc61009368 \h 11511.1Genetic Modification PAGEREF _Toc61009369 \h 11611.1.1 Gene Modification to Improve Migration PAGEREF _Toc61009370 \h 11611.1.2 Gene Modification to Improve Adhesion PAGEREF _Toc61009371 \h 11611.1.3 Genetic Modification to Improve Survival PAGEREF _Toc61009372 \h 11611.1.4 Genetic Modification to Reduce Premature Senescence PAGEREF _Toc61009373 \h 11711.2Preconditioning Modifications PAGEREF _Toc61009374 \h 11711.2.1 Preconditioning to Improve Migration PAGEREF _Toc61009375 \h 11711.2.2 Preconditioning to Improve Adhesion PAGEREF _Toc61009376 \h 11811.2.3 Preconditioning to Improve Survival PAGEREF _Toc61009377 \h 11811.2.4 Preconditioning to Reduce Senescence PAGEREF _Toc61009378 \h 11811.3Therapeutic Application of Modified MSCs PAGEREF _Toc61009379 \h 11811.3.1 Modified MSCs for Neurological Conditions PAGEREF _Toc61009380 \h 11911.3.2 Modified MSCs for Cardiovascular Diseases PAGEREF _Toc61009381 \h 12011.3.3 Modified MSCs for Lung Injury PAGEREF _Toc61009382 \h 12011.3.4 Modified MSCs for Diabetes PAGEREF _Toc61009383 \h 12112.MAJOR DISEASES ADDRESSED BY MSCS IN CLINICAL TRIALS PAGEREF _Toc61009384 \h 12212.1Clinical Trials using MSCs for Autoimmune Diseases PAGEREF _Toc61009385 \h 12212.2Clinical Trials using MSCs for Cardiovascular Diseases PAGEREF _Toc61009386 \h 12312.3Clinical Trials using MSCs for Neurodegenerative Diseases PAGEREF _Toc61009387 \h 12412.4Clinical Trials using MSCs for Bone and Cartilage Diseases PAGEREF _Toc61009388 \h 12513.PRESENT STATUS OF MESENCHYMAL STEM CELL INDUSTRY PAGEREF _Toc61009389 \h 12713.1Sources of MSCs for Research and Clinical Applications PAGEREF _Toc61009390 \h 12713.2Allogeneic Products Gaining Traction PAGEREF _Toc61009391 \h 12813.3MSC-Based Products with Marketing Approval PAGEREF _Toc61009392 \h 12913.3.1 Alofisel PAGEREF _Toc61009393 \h 13113.3.2 Stemirac PAGEREF _Toc61009394 \h 13213.3.3 Stempeucel PAGEREF _Toc61009395 \h 13213.3.4 Temcell HS PAGEREF _Toc61009396 \h 13213.3.5 Neuronata-R PAGEREF _Toc61009397 \h 13313.3.6 Prochymal (Remestemcel-L) PAGEREF _Toc61009398 \h 13313.3.7 Cupistem PAGEREF _Toc61009399 \h 13313.3.8 Cartistem PAGEREF _Toc61009400 \h 13313.3.9 Cellgram-AMI PAGEREF _Toc61009401 \h 13413.3.10 Queencell PAGEREF _Toc61009402 \h 13413.4Currently Marketed MSC-Based Bone Matrices PAGEREF _Toc61009403 \h 13413.4.1 Osteocel PAGEREF _Toc61009404 \h 13513.4.2 AlloStem PAGEREF _Toc61009405 \h 13613.4.3 Cellentra VCBM PAGEREF _Toc61009406 \h 13613.4.4 HiQCell PAGEREF _Toc61009407 \h 13713.4.5 Trinity ELITE PAGEREF _Toc61009408 \h 13713.4.6 Map3 PAGEREF _Toc61009409 \h 13713.4.7 Trinity Evolution PAGEREF _Toc61009410 \h 13713.4.8 Carticel PAGEREF _Toc61009411 \h 13813.4.9 Chondron PAGEREF _Toc61009412 \h 13813.4.10 DeNovo NT PAGEREF _Toc61009413 \h 13813.4.11 Chondrocelect PAGEREF _Toc61009414 \h 13813.4.12 Ossron PAGEREF _Toc61009415 \h 13913.4.13 JACC PAGEREF _Toc61009416 \h 13913.4.14 MACI PAGEREF _Toc61009417 \h 13913.4.15 Ortho-ACI PAGEREF _Toc61009418 \h 14013.4.16 Spherox PAGEREF _Toc61009419 \h 14013.4.17 Ossgrow PAGEREF _Toc61009420 \h 14013.4.18 Cartigrow PAGEREF _Toc61009421 \h 14113.4.19 ViviGen PAGEREF _Toc61009422 \h 14113.4.20 Bio4 PAGEREF _Toc61009423 \h 14113.4.21 Cartiform PAGEREF _Toc61009424 \h 14113.5From Whole Cell MSC Therapy to MSC-Derived Exosome Therapy PAGEREF _Toc61009425 \h 14213.5.1 Advantages of MSC-Derived Exosomes PAGEREF _Toc61009426 \h 14213.5.2 Contents of MSC-Derived Exosomes PAGEREF _Toc61009427 \h 14213.5.3 Exosomes as Diagnostics PAGEREF _Toc61009428 \h 14313.5.4 Exosomes as Drug Delivery Vectors PAGEREF _Toc61009429 \h 14313.6MSC-Based Therapy for COVID-19 PAGEREF _Toc61009430 \h 14313.7MSC-Based Clean Meat Production PAGEREF _Toc61009431 \h 14413.8Stem Cell-Based Cosmetics PAGEREF _Toc61009432 \h 14413.8.1 Marketed Stem Cell-Based Cosmetic Products PAGEREF _Toc61009433 \h 14514.MARKET ANALYSIS PAGEREF _Toc61009434 \h 15314.1Price Tags for MSC-Based Cell Therapy (CT) Treatment PAGEREF _Toc61009435 \h 15414.2Price Tags for MSC-Based Matrices PAGEREF _Toc61009436 \h 15514.3Market Size of MSC-Based Therapies PAGEREF _Toc61009437 \h 15614.4Global Market for MSC-based Therapeutics PAGEREF _Toc61009438 \h 15714.5Global Demand for Mesenchymal Stem Cells (MSCs) PAGEREF _Toc61009439 \h 15914.5.1 MSCs Required for Academic and Preclinical Research PAGEREF _Toc61009440 \h 15914.5.2 Required MSCs for Clinical Trials PAGEREF _Toc61009441 \h 15914.5.3 MSCs Required for Developing MSC-Based Therapeutics PAGEREF _Toc61009442 \h 15914.5.4 MSCs Required for Developing MSC-Derived Products PAGEREF _Toc61009443 \h 16014.5.5 MSCs Required for Emerging Industries PAGEREF _Toc61009444 \h 16014.5.6 Global Market Size for Mesenchymal Stem Cells PAGEREF _Toc61009445 \h 16014.6Market Share of MSC-Based Business Segments PAGEREF _Toc61009446 \h PANY PROFILES PAGEREF _Toc61009447 \h 16415.1101 Bio PAGEREF _Toc61009448 \h 16415.1.1 Exosome Services PAGEREF _Toc61009449 \h 16415.2Adipomics, Inc. PAGEREF _Toc61009450 \h 16515.3Aegle Therapeutics PAGEREF _Toc61009451 \h 16515.3.1 Aegle’s Platform Technology PAGEREF _Toc61009452 \h 16615.3.1.1Epidermolysis Bullosa PAGEREF _Toc61009453 \h 16615.4Aethlon Medical, Inc. PAGEREF _Toc61009454 \h 16615.4.1 Hemopurifier in Cancer PAGEREF _Toc61009455 \h 16715.5AgeX Therapeutics, Inc. PAGEREF _Toc61009456 \h 16715.5.1 PureStem Technology PAGEREF _Toc61009457 \h 16715.5.2 Induced Tissue Regeneration (iTR) PAGEREF _Toc61009458 \h 16815.5.3 UniverCyte PAGEREF _Toc61009459 \h 16815.6Alexerion Biotech Corp. PAGEREF _Toc61009460 \h 16915.6.1 Drug Development PAGEREF _Toc61009461 \h 16915.7AlloSource, Inc. PAGEREF _Toc61009462 \h 17015.7.1 Products PAGEREF _Toc61009463 \h 17015.7.1.1AlloStem PAGEREF _Toc61009464 \h 17015.8American CryoStem Corporation PAGEREF _Toc61009465 \h 17115.8.1 Services PAGEREF _Toc61009466 \h 17115.8.1.1ATGRAFT Fat Storage PAGEREF _Toc61009467 \h 17115.8.1.2Adult Stem Cell Program PAGEREF _Toc61009468 \h 17115.8.2 Products PAGEREF _Toc61009469 \h 17115.8.2.1CELECT Tissue Harvesting System PAGEREF _Toc61009470 \h 17115.8.2.2ATCELL-AD-MSCs PAGEREF _Toc61009471 \h 17215.8.2.3ACSelerateMAX Growth Medium PAGEREF _Toc61009472 \h 17215.9American Type Culture Collection (ATCC) PAGEREF _Toc61009473 \h 17315.9.1 Stem Cell Products PAGEREF _Toc61009474 \h 17315.10AMS Biotechnology, Ltd. (AMSBIO) PAGEREF _Toc61009475 \h 17415.10.1 Products PAGEREF _Toc61009476 \h 17415.11Anemocyte S.r.l PAGEREF _Toc61009477 \h 17515.11.1 Total GMP Capacity PAGEREF _Toc61009478 \h 17515.11.2 Product Types PAGEREF _Toc61009479 \h 17515.11.3 Manufacturing Services PAGEREF _Toc61009480 \h 17515.12Anjarium Biosciences PAGEREF _Toc61009481 \h 17615.12.1 Anjarium’s Hybridosome Platform PAGEREF _Toc61009482 \h 17615.13Anterogen, Co., Ltd. PAGEREF _Toc61009483 \h 17715.13.1 Products PAGEREF _Toc61009484 \h 17715.13.1.1Cupistem Injection PAGEREF _Toc61009485 \h 17715.13.1.2Queencell Injection PAGEREF _Toc61009486 \h 17715.14Apceth Biopharma GmbH PAGEREF _Toc61009487 \h 17815.14.1 Global Services PAGEREF _Toc61009488 \h 17815.14.2 Assay Development Services PAGEREF _Toc61009489 \h 17915.15Aruna Bio PAGEREF _Toc61009490 \h 18015.15.1 AB126 PAGEREF _Toc61009491 \h 18015.16Athersys, Inc. PAGEREF _Toc61009492 \h 18115.16.1 MultiStem PAGEREF _Toc61009493 \h 18115.17Avalon GloboCare Corp. PAGEREF _Toc61009494 \h 18215.17.1 Avalon’s Core Platforms PAGEREF _Toc61009495 \h 18215.18Axol Bioscience, Ltd. PAGEREF _Toc61009496 \h 18315.18.1 Products PAGEREF _Toc61009497 \h 18315.19Azymus Therapeutics PAGEREF _Toc61009498 \h 18415.19.1 AZ Platform PAGEREF _Toc61009499 \h 18415.20BioCat GmbH PAGEREF _Toc61009500 \h 18515.20.1 Exosome Purification Kits PAGEREF _Toc61009501 \h 18515.21BioFluidica PAGEREF _Toc61009502 \h 18615.21.1 Technology Platform PAGEREF _Toc61009503 \h 18615.22Bio-Techne PAGEREF _Toc61009504 \h 18715.22.1 Total GMP Capacity PAGEREF _Toc61009505 \h 18715.22.2 Prtoduct Types PAGEREF _Toc61009506 \h 18715.23BioVision, Inc. PAGEREF _Toc61009507 \h 18815.24Baylx, Inc. PAGEREF _Toc61009508 \h 18915.24.1 Product Candidates PAGEREF _Toc61009509 \h 18915.25BrainStorm Cell Therapeutics PAGEREF _Toc61009510 \h 19015.25.1 MSC-NTF Cells PAGEREF _Toc61009511 \h 19015.26Capricor Therapeutics PAGEREF _Toc61009512 \h 19115.26.1 Exosome Program PAGEREF _Toc61009513 \h 19115.27Catalent Pharma Solutions PAGEREF _Toc61009514 \h 19215.27.1 Cell Therapy Expertise PAGEREF _Toc61009515 \h 19215.28CCRM PAGEREF _Toc61009516 \h 19315.28.1 Total GMP Capacity PAGEREF _Toc61009517 \h 19315.28.2 Product Types PAGEREF _Toc61009518 \h 19315.28.3 Manufacturing Services PAGEREF _Toc61009519 \h 19315.29CellResearch Corporation, Pte Ltd. PAGEREF _Toc61009520 \h 19415.29.1 Umbilical Cord Lining Stem Cells PAGEREF _Toc61009521 \h 19415.30Celltex Therapeutics Corporation PAGEREF _Toc61009522 \h 19515.30.1 Therapy Services PAGEREF _Toc61009523 \h 19515.31Ciloa PAGEREF _Toc61009524 \h 19615.31.1 Exosome Customization Technology PAGEREF _Toc61009525 \h 19615.32Codiak Biosciences PAGEREF _Toc61009526 \h 19715.32.1 engEx Platform PAGEREF _Toc61009527 \h 19715.32.2 exoASO-STAT6 PAGEREF _Toc61009528 \h 19715.32.3 exoIL-12 PAGEREF _Toc61009529 \h 19715.33Corestem, Inc. PAGEREF _Toc61009530 \h 19815.33.1 Neuronata-R PAGEREF _Toc61009531 \h 19815.34CO-DON AG PAGEREF _Toc61009532 \h 19915.34.1 M-ACT PAGEREF _Toc61009533 \h 19915.35Cognate BioServices, Inc. PAGEREF _Toc61009534 \h 20015.35.1 Total GMP Capacity PAGEREF _Toc61009535 \h 20015.35.2 Product Types PAGEREF _Toc61009536 \h 20015.36Creative Bioarray PAGEREF _Toc61009537 \h 20115.37Creative Biolabs PAGEREF _Toc61009538 \h 20115.37.1 Products PAGEREF _Toc61009539 \h 20215.37.2 Services PAGEREF _Toc61009540 \h 20215.38Cynata Therapeutics, Ltd. PAGEREF _Toc61009541 \h 20315.38.1 Cymerus Platform PAGEREF _Toc61009542 \h 20315.38.2 GvHD PAGEREF _Toc61009543 \h 20315.38.3 Critical Limb Ischemia PAGEREF _Toc61009544 \h 20415.38.4 Asthma PAGEREF _Toc61009545 \h 20415.38.5 Heart Attack PAGEREF _Toc61009546 \h 20415.38.6 Diabetic Wounds PAGEREF _Toc61009547 \h 20415.38.7 Coronary Artery Disease (CAD) PAGEREF _Toc61009548 \h 20515.38.8 Acute Respiratory Distress Syndrome (ARDS) PAGEREF _Toc61009549 \h 20515.38.9 Sepsis PAGEREF _Toc61009550 \h 20515.38.10Osteoarthritis PAGEREF _Toc61009551 \h 20515.39DePuy Synthes PAGEREF _Toc61009552 \h 20615.39.1 ViviGen PAGEREF _Toc61009553 \h 20615.40Direct Biologics PAGEREF _Toc61009554 \h 20715.40.1 ExoFlo PAGEREF _Toc61009555 \h 20715.41EVerZom PAGEREF _Toc61009556 \h 20815.41.1 Services PAGEREF _Toc61009557 \h 20815.42Evox Therapeutics, Ltd. PAGEREF _Toc61009558 \h 20915.42.1 Protein Therapeutics – REPLACE PAGEREF _Toc61009559 \h 20915.42.2 RNA Therapeutics – CORRECT PAGEREF _Toc61009560 \h 20915.43Exerkine Corp. PAGEREF _Toc61009561 \h 21015.43.1 Clinical Development PAGEREF _Toc61009562 \h 21015.43.1.1Genetic Diseases PAGEREF _Toc61009563 \h 21015.43.1.2Aging-Associated Diseases PAGEREF _Toc61009564 \h 21015.44ExoCan Healthcare Technologies, Pvt. Ltd. PAGEREF _Toc61009565 \h 21115.44.1 Technology PAGEREF _Toc61009566 \h 21115.44.1.1ExoEnrich Exosome Isolation Kit PAGEREF _Toc61009567 \h 21115.44.1.2ExoEngineering PAGEREF _Toc61009568 \h 21115.45ExoCoBio, Co., Ltd. PAGEREF _Toc61009569 \h 21215.45.1 Products PAGEREF _Toc61009570 \h 21215.46Exogenus Therapeutics PAGEREF _Toc61009571 \h 21315.47EXoPERT PAGEREF _Toc61009572 \h 21415.47.1 EXo-i PAGEREF _Toc61009573 \h 21415.48Exopharm PAGEREF _Toc61009574 \h 21515.48.1 LEAP Technology PAGEREF _Toc61009575 \h 21515.48.2 Cevaris & Plexaris PAGEREF _Toc61009576 \h 21515.49Exosome Diagnostics, Inc. PAGEREF _Toc61009577 \h 21615.49.1 ExoDx Prostate Test PAGEREF _Toc61009578 \h 21615.50ExosomePlus PAGEREF _Toc61009579 \h 21715.51Exosome Sciences PAGEREF _Toc61009580 \h 21815.51.1 TauSome Biomarker PAGEREF _Toc61009581 \h 21815.52Exosomics S.p.A PAGEREF _Toc61009582 \h 21915.52.1 ExoRef PAGEREF _Toc61009583 \h 21915.52.2 SeleCTEV Enrichment Kits PAGEREF _Toc61009584 \h 21915.52.3 SoRTEV Enrichment Kit PAGEREF _Toc61009585 \h 21915.53Fraunhofer Institute for Cell Therapy and Immunology PAGEREF _Toc61009586 \h 22015.53.1 Total GMP Capacity PAGEREF _Toc61009587 \h 22015.53.2 Product Types PAGEREF _Toc61009588 \h 22015.53.3 Manufacturing Services PAGEREF _Toc61009589 \h 22015.54HansaBioMed Life Sciences, Ltd. PAGEREF _Toc61009590 \h 22115.54.1 Products PAGEREF _Toc61009591 \h 22115.55Hope Biosciences, LLC PAGEREF _Toc61009592 \h 22215.55.1 Hope’s Cell Culture Process PAGEREF _Toc61009593 \h 22215.56Japan Tissue Engineering, Co., Ltd. PAGEREF _Toc61009594 \h 22315.56.1 JACC PAGEREF _Toc61009595 \h 22315.57JCR Pharmaceuticals, Co., Ltd. PAGEREF _Toc61009596 \h 22415.57.1 TEMCELL HS Inj. PAGEREF _Toc61009597 \h 22415.58Kimera Labs, Inc. PAGEREF _Toc61009598 \h 22415.59Lonza Group Ltd. PAGEREF _Toc61009599 \h 22515.59.1 Total GMP Capacity PAGEREF _Toc61009600 \h 22515.59.2 Product Types PAGEREF _Toc61009601 \h 22515.59.3 Manufacturing Services PAGEREF _Toc61009602 \h 22515.60Mantra Bio PAGEREF _Toc61009603 \h 22615.60.1 Partnering PAGEREF _Toc61009604 \h 22615.61Medipost, Co., Ltd. PAGEREF _Toc61009605 \h 22715.61.1 Cartistem PAGEREF _Toc61009606 \h 22715.62MDimune PAGEREF _Toc61009607 \h 22815.62.1 BioDrone Technology PAGEREF _Toc61009608 \h 22815.63NanoSomix, Inc. PAGEREF _Toc61009609 \h 22915.63.1 Technology PAGEREF _Toc61009610 \h 22915.64NanoView Biosciences PAGEREF _Toc61009611 \h 23015.64.1 Products PAGEREF _Toc61009612 \h 23015.64.1.1ExoView R 100 PAGEREF _Toc61009613 \h 23015.64.1.2ExoView Tetraspanin Kits PAGEREF _Toc61009614 \h 23015.65NeurExo Sciences PAGEREF _Toc61009615 \h 23115.66Nipro Corporation PAGEREF _Toc61009616 \h 23215.66.1 Stemirac PAGEREF _Toc61009617 \h 23215.67Novus Biologicals, LLC PAGEREF _Toc61009618 \h 23315.67.1 Exosomes Research Tools PAGEREF _Toc61009619 \h 23315.68NuVasive, Inc. PAGEREF _Toc61009620 \h 23415.68.1 Osteocel Family PAGEREF _Toc61009621 \h 23415.69OmniSpirant Limited PAGEREF _Toc61009622 \h 23515.69.1 Technology PAGEREF _Toc61009623 \h 23515.70Orthocell, Ltd. PAGEREF _Toc61009624 \h 23615.70.1 Ortho-ATI PAGEREF _Toc61009625 \h 23615.70.2 CelGro PAGEREF _Toc61009626 \h 23615.71Orthofix Medical, Inc. PAGEREF _Toc61009627 \h 23715.71.1 Trinity ELITE PAGEREF _Toc61009628 \h 23715.71.2 Trinity EVOLUTION PAGEREF _Toc61009629 \h 23715.72Osiris Therapeutics, Inc. PAGEREF _Toc61009630 \h 23815.72.1 Cartiform PAGEREF _Toc61009631 \h 23815.72.2 Bio4 PAGEREF _Toc61009632 \h 23815.73Pharmicell, Co., Ltd. PAGEREF _Toc61009633 \h 23915.73.1 Cellgram-AMI PAGEREF _Toc61009634 \h 23915.73.2 Stem Cell Culture Media Cosmetics PAGEREF _Toc61009635 \h 24015.74Pluristem Therapeutics, Inc. PAGEREF _Toc61009636 \h 24115.74.1 Products PAGEREF _Toc61009637 \h 24115.74.2 PLX-PAD PAGEREF _Toc61009638 \h 24115.74.3 PLX-R18 PAGEREF _Toc61009639 \h 24215.74.4 PLX-Immune PAGEREF _Toc61009640 \h 24215.74.5 Partnerships and Collaborations PAGEREF _Toc61009641 \h 24315.74.5.1Collaboration with NASA PAGEREF _Toc61009642 \h 24315.74.5.2Collaboration with NIAID PAGEREF _Toc61009643 \h 24315.74.5.3Collaboration with U.S. Department of Defence (DOD) PAGEREF _Toc61009644 \h 24315.74.5.4License Agreement with Chart Industries, Inc. PAGEREF _Toc61009645 \h 24315.74.5.5Collaboration with Thermo Fisher Scientific PAGEREF _Toc61009646 \h 24415.74.5.6Partnership with Cha Biotech PAGEREF _Toc61009647 \h 24415.75Regeneus, Ltd. PAGEREF _Toc61009648 \h 24515.75.1 HiQCell PAGEREF _Toc61009649 \h 24515.76Regrow Biosciences, Pvt., Ltd. PAGEREF _Toc61009650 \h 24615.76.1 Ossgrow PAGEREF _Toc61009651 \h 24615.76.2 Cartigrow PAGEREF _Toc61009652 \h 24615.77ReNeuron PAGEREF _Toc61009653 \h 24715.77.1 Exosome Platform PAGEREF _Toc61009654 \h 24715.78RoosterBio PAGEREF _Toc61009655 \h 24815.78.1 Products PAGEREF _Toc61009656 \h 24815.78.2 Services PAGEREF _Toc61009657 \h 24915.79RoslinCT PAGEREF _Toc61009658 \h 25015.79.1 Total GMP Capacity PAGEREF _Toc61009659 \h 25015.79.2 Product Types PAGEREF _Toc61009660 \h 25015.79.3 Manufacturing Services PAGEREF _Toc61009661 \h 25015.80RTI Surgical, Inc. PAGEREF _Toc61009662 \h 25115.80.1 Map3 Allograft Chips PAGEREF _Toc61009663 \h 25115.81Sentien Biotechnologies, Inc. PAGEREF _Toc61009664 \h 25215.81.1 SBI-101 PAGEREF _Toc61009665 \h 25215.81.2 Pipeline PAGEREF _Toc61009666 \h 25315.82STEMCELL Technologies, Inc. PAGEREF _Toc61009667 \h 25415.82.1 Products PAGEREF _Toc61009668 \h 25415.83Stemedica Cell Technologies, Inc. PAGEREF _Toc61009669 \h 25515.83.1 BioSmart Technology PAGEREF _Toc61009670 \h 25515.83.2 Pipeline PAGEREF _Toc61009671 \h 25515.84Stemmatters Biotechnologia e Medicina Regenerative SA PAGEREF _Toc61009672 \h 25615.85Stempeutics Research, Pvt., Ltd. PAGEREF _Toc61009673 \h 25715.85.1 Stempeucel PAGEREF _Toc61009674 \h 25715.85.2 Stempeutron PAGEREF _Toc61009675 \h 25715.85.3 Stempeucare (Cutisera) PAGEREF _Toc61009676 \h 25815.86System Biosciences, LLC PAGEREF _Toc61009677 \h 25915.86.1 Products PAGEREF _Toc61009678 \h 25915.86.2 Services PAGEREF _Toc61009679 \h 25915.87Takeda Pharmaceuticals U.S.A., Inc. PAGEREF _Toc61009680 \h 26015.87.1 Alofisel PAGEREF _Toc61009681 \h 26015.88Tempo Bioscience PAGEREF _Toc61009682 \h 26115.88.1 Products PAGEREF _Toc61009683 \h 26115.88.1.1Human Cell Models PAGEREF _Toc61009684 \h 26115.88.1.2Services & Alliances PAGEREF _Toc61009685 \h 26215.89Tavec Pharma PAGEREF _Toc61009686 \h 26315.89.1 Technology PAGEREF _Toc61009687 \h 26315.90United Therapeutics Corp. PAGEREF _Toc61009688 \h 26415.90.1 Unexisome PAGEREF _Toc61009689 \h 26415.91Vericel Corporation PAGEREF _Toc61009690 \h 26515.91.1 MACI PAGEREF _Toc61009691 \h 26515.91.2 Carticel PAGEREF _Toc61009692 \h 26515.92Versatope Therapeutics PAGEREF _Toc61009693 \h 26615.92.1 VT-105 PAGEREF _Toc61009694 \h 26615.93Vesigen Therapeutics, Inc. PAGEREF _Toc61009695 \h 26715.93.1 Technology PAGEREF _Toc61009696 \h 26715.94Waisman Biomanufacturing PAGEREF _Toc61009697 \h 26815.94.1 Total GMP Capacity PAGEREF _Toc61009698 \h 26815.94.2 Product Types PAGEREF _Toc61009699 \h 26815.94.3 Manufacturing Services PAGEREF _Toc61009700 \h 26815.95WuXi Advanced Therapies PAGEREF _Toc61009701 \h 26915.95.1 Total GMP Capacity PAGEREF _Toc61009702 \h 26915.95.2 Product Types PAGEREF _Toc61009703 \h 26915.96XOStem, Inc. PAGEREF _Toc61009704 \h 27015.97Zen-Bio, Inc. PAGEREF _Toc61009705 \h 27115.97.1 Products PAGEREF _Toc61009706 \h 27115.97.1.1Human Exosomes PAGEREF _Toc61009707 \h 27215.97.2 Contract Services PAGEREF _Toc61009708 \h 27315.98Zimmer Biomet PAGEREF _Toc61009709 \h 27415.98.1 Cellentra PAGEREF _Toc61009710 \h 274 TOC \o "4-4" \h \z \t "Heading 1,1,Heading 2,2,Heading 3,3" INDEX OF FIGURES TOC \h \z \t "Figure,1" FIGURE 3.1: Monolayer Culture Systems PAGEREF _Toc61011996 \h 36FIGURE 3.2: Stirred Tank Bioreactor PAGEREF _Toc61011997 \h 37FIGURE 3.3: Rocking Bioreactor PAGEREF _Toc61011998 \h 38FIGURE 3.4: Hollow Fiber Bioreactors PAGEREF _Toc61011999 \h 39FIGURE 3.5: Fixed-Bed Bioreactors PAGEREF _Toc61012000 \h 39FIGURE 3.6: Single-Use Harvestainer for Small Scale Application PAGEREF _Toc61012001 \h 49FIGURE 3.7: Single-Use Harvestainer for Large Scale Application PAGEREF _Toc61012002 \h 49FIGURE 4.1: CoG in MSC Manufacturing PAGEREF _Toc61012003 \h 56FIGURE 4.2: Impact of Head Count on Overall CoG per Batch PAGEREF _Toc61012004 \h 57FIGURE 4.3: CoG Breakdown in Partially-Automated MSC Manufacturing PAGEREF _Toc61012005 \h 58FIGURE 4.4: Cost Breakdown in Fully Automated MSC Manufacturing PAGEREF _Toc61012006 \h 59FIGURE 4.5: Higher Throughput in Partially Automated Facilities PAGEREF _Toc61012007 \h 60FIGURE 5.1: Diagrammatic Representation of SelecT Automated Platform by Sartorius PAGEREF _Toc61012008 \h 65FIGURE 5.2: Model of a Clean Room in a Small-Scale Manufacturing Facility PAGEREF _Toc61012009 \h 66FIGURE 6.1: The Four Common Bioprocessing Strategies PAGEREF _Toc61012010 \h 69FIGURE 6.2: Large-Scale Expansion of MSCs by Source PAGEREF _Toc61012011 \h 69FIGURE 6.3: Commonly used Culture Media in the Large-Scale Expansion of MSCs PAGEREF _Toc61012012 \h 70FIGURE 6.4: Major Services Offered by CMOs PAGEREF _Toc61012013 \h 74FIGURE 6.5: Regional Distribution of CMOs PAGEREF _Toc61012014 \h 75FIGURE 7.1: Share of Published Papers by Type PAGEREF _Toc61012015 \h 78FIGURE 7.2: Consumption of MSCs in Academic and Preclinical Settings PAGEREF _Toc61012016 \h 79FIGURE 7.3: MSC Consumption in Clinical Settings PAGEREF _Toc61012017 \h 80FIGURE 7.4: Consumption of MSCs by Target Indications in Clinical Trials PAGEREF _Toc61012018 \h 80FIGURE 8.1: Number of Published Papers on MSCs between 2010 and 2020 PAGEREF _Toc61012019 \h 85FIGURE 8.2: Number of Published Papers for MSCs and iPSCs Compared, 2010-2020 PAGEREF _Toc61012020 \h 86FIGURE 8.3: Number of Papers on MSCs by Source PAGEREF _Toc61012021 \h 88FIGURE 8.4: Number of Papers on Clinical Trials Involving MSCs, 2010-2019 PAGEREF _Toc61012022 \h 89FIGURE 8.5: Percent Share of Specific Diseases in Clinical Trials PAGEREF _Toc61012023 \h 90FIGURE 9.1: Distribution of Clinical Trials involving MSCs across the World, 2020 PAGEREF _Toc61012024 \h 92FIGURE 9.2: Clinical Trials Involving MSCs by Source PAGEREF _Toc61012025 \h 93FIGURE 9.3: Clinical Trials Involving Autologous and Allogeneic MSCs PAGEREF _Toc61012026 \h 94FIGURE 9.4: Distribution of MSC-Based Clinical Trials by Geography, 2020 PAGEREF _Toc61012027 \h 95FIGURE 9.5: Type of Funding for MSC-Based Clinical Trials PAGEREF _Toc61012028 \h 97FIGURE 9.6: The Three Types of Ongoing MSC-Based Clinical Trials, 2020 PAGEREF _Toc61012029 \h 98FIGURE 9.7: MSC-Based Clinical Trials by Phase of Development, 2020 PAGEREF _Toc61012030 \h 99FIGURE 9.8: MSC-Based COVID-19 Clinical Trials by Geography PAGEREF _Toc61012031 \h 100FIGURE 10.1: Bioengineering Solutions to Boost the Function of MSC PAGEREF _Toc61012032 \h 109FIGURE 10.2: Bioengineering Solutions for Improving Administration of MSCs PAGEREF _Toc61012033 \h 113FIGURE 10.3: Solutions to Overcome Host Factors PAGEREF _Toc61012034 \h 114FIGURE 11.1: Four Focal Points of Enhancement of MSC’s Properties during Modification PAGEREF _Toc61012035 \h 115FIGURE 11.2: The Cycle of Na?ve MSCs to Modified MSCs for Clinical Application PAGEREF _Toc61012036 \h 119FIGURE 12.1: Major Diseases Addressed by MSCs in Clinical Trials PAGEREF _Toc61012037 \h 122FIGURE 12.2: Percent Share of Autoimmune Diseases in Clinical Trials using MSCs PAGEREF _Toc61012038 \h 123FIGURE 12.3: Percent Share of MSC by Source in Trials for Cardiovascular Diseases PAGEREF _Toc61012039 \h 124FIGURE 12.4: Percent Shares of Neurodenerative Diseases in Clinical Trials using MSCs PAGEREF _Toc61012040 \h 125FIGURE 12.5: Percent Share of MSC by Source in Trials for Bone & Cartilage Diseases PAGEREF _Toc61012041 \h 126FIGURE 14.1: Percent Share of Marketed CT, GT and TE Products PAGEREF _Toc61012042 \h 153FIGURE 14.2: Percent Share of CT Products by Indication PAGEREF _Toc61012043 \h 154FIGURE 14.3: Market for MSC-Based Cell Therapy Products by Geography, 2020-2027 PAGEREF _Toc61012044 \h 158FIGURE 14.4: Global Market for Mesenchymal Stem Cells by Geography, 2020-2027 PAGEREF _Toc61012045 \h 161FIGURE 14.5: Market Share of MSCc by Business Segments PAGEREF _Toc61012046 \h 163INDEX OF TABLES TOC \h \z \t "Heading 6,1" TABLE 2.1: Timeline of MSC Nomeclature PAGEREF _Toc61012430 \h 27TABLE 2.2: Sources of MSCs PAGEREF _Toc61012431 \h 28TABLE 2.3: Advantages and Disadvantages of BM-MSCs PAGEREF _Toc61012432 \h 29TABLE 2.4: Advantages and Disadvantages of AD-MSCs PAGEREF _Toc61012433 \h 29TABLE 2.5: Advantages and Disadvantages of UC-MSCs PAGEREF _Toc61012434 \h 30TABLE 2.6: Positive and Negative Markers for MSCs Derived from Different Sources PAGEREF _Toc61012435 \h 30TABLE 2.7: In Vitro Differentiation Potentials of MSCs PAGEREF _Toc61012436 \h 31TABLE 2.8: Soluble Factors Secreted by MSCs PAGEREF _Toc61012437 \h 32TABLE 3.1: Initial Story of MSCs: A Snapshot PAGEREF _Toc61012438 \h 34TABLE 3.2: Methods of Isolation of MSCs and Corresponding Culture Media PAGEREF _Toc61012439 \h 35TABLE 3.3: A Snapshot of Commercially Available Culture Systems PAGEREF _Toc61012440 \h 40TABLE 3.3: (CONTINUED) PAGEREF _Toc61012441 \h 41TABLE 3.3: (CONTINUED) PAGEREF _Toc61012442 \h 42TABLE 3.3: (CONTINUED) PAGEREF _Toc61012443 \h 43TABLE 3.3: (CONTINUED) PAGEREF _Toc61012444 \h 44TABLE 3.4: Main Features of Commercally Available Bioreactors PAGEREF _Toc61012445 \h 45TABLE 3.5: Microcarriers used for the Expansion of MSCs PAGEREF _Toc61012446 \h 46TABLE 3.5: (CONTINUED) PAGEREF _Toc61012447 \h 47TABLE 3.5: (CONTINUED) PAGEREF _Toc61012448 \h 48TABLE 3.6: Basic Assays for MSCs PAGEREF _Toc61012449 \h 50TABLE 3.7: Cell Surface Markers on MSCs and Fibroblasts PAGEREF _Toc61012450 \h 51TABLE 4.1: Cost of Manufacturing Allogeneic MSCs PAGEREF _Toc61012451 \h 52TABLE 4.2: Cost of Manufacturing Autologous MSCs PAGEREF _Toc61012452 \h 53TABLE 4.3: Comparison of Allogeneic and Autologous Therapies PAGEREF _Toc61012453 \h 55TABLE 4.4: Cost of Goods (CoG) in MSC Manufacturing PAGEREF _Toc61012454 \h 56TABLE 4.5: CoG Breakdown in Partially-Automated MSC Manufacturing PAGEREF _Toc61012455 \h 58TABLE 4.6: Cost Breakdown in Fully Automated MSC Manufacturing PAGEREF _Toc61012456 \h 59TABLE 4.7: Higher Throughput in Partially Automated Facilities PAGEREF _Toc61012457 \h 60TABLE 5.1: Key Process and Cost Assumptions PAGEREF _Toc61012458 \h 62TABLE 5.2: Quality Control Panel with Cost Assessments PAGEREF _Toc61012459 \h 63TABLE 5.3: Additional Supporting Labor Cost Assumptions PAGEREF _Toc61012460 \h 63TABLE 5.3: (CONTINUED) PAGEREF _Toc61012461 \h 64TABLE 5.4: Additional Supporting Facility and Process Assumptions PAGEREF _Toc61012462 \h 64TABLE 5.4: (CONTINUED) PAGEREF _Toc61012463 \h 65TABLE 6.1: Large-Scale Expansion of MSCs by Method, Cell Source and Media PAGEREF _Toc61012464 \h 67TABLE 6.1: (CONTINUED) PAGEREF _Toc61012465 \h 68TABLE 6.2: Expansion Ratio Achieved with Different Culture Media PAGEREF _Toc61012466 \h 71TABLE 6.3: Comparison between Large-Scale Bioprocessing Strategies PAGEREF _Toc61012467 \h 72TABLE 6.4: Regional Distribution of CMOs PAGEREF _Toc61012468 \h 74TABLE 6.5: Global Cell Therapy Manufacturing Capacity PAGEREF _Toc61012469 \h 76TABLE 6.6: Major CDMOs and CMOs in North America PAGEREF _Toc61012470 \h 76TABLE 6.7: Major CDMOs and CMOs in Europe PAGEREF _Toc61012471 \h 77TABLE 7.1: Cost of MSCs per Patient in Clinical Trials by Indication PAGEREF _Toc61012472 \h 83TABLE 8.1: Number of Published Papers on MSCs between 2010 and 2020 PAGEREF _Toc61012473 \h 84TABLE 8.2: Number of Papers on MSCs & iPSCs Compared between 2010 and 2020 PAGEREF _Toc61012474 \h 86TABLE 8.3: Number of Papers on MSCs by Source PAGEREF _Toc61012475 \h 87TABLE 8.4: Number of Papers on Clinical Trials Involving MSCs, 2010-2020 PAGEREF _Toc61012476 \h 88TABLE 8.5: Number of Papers on Trials using MSCs for Specific Diseases, 2010-2020 PAGEREF _Toc61012477 \h 90TABLE 9.1: Number of Clinical Trials Involving MSCs by Region as of Apr. 2020 PAGEREF _Toc61012478 \h 91TABLE 9.2: Clinical Trials Involving MSCs by Source PAGEREF _Toc61012479 \h 93TABLE 9.3: Clinical Trials Involving Autologous vs. Allogeneic MSCs PAGEREF _Toc61012480 \h 94TABLE 9.4: Distribution of MSC-Based Clinical Trials by Geography, 2020 PAGEREF _Toc61012481 \h 95TABLE 9.5: Number of MSC-Based Clinical Trials by Country as of 2020 PAGEREF _Toc61012482 \h 96TABLE 9.6: Type of Funding for MSC-Based Clinical Trials, 2020 PAGEREF _Toc61012483 \h 97TABLE 9.7: The Three Types of Ongoing MSC-Based Clinical Trials, 2020 PAGEREF _Toc61012484 \h 98TABLE 9.8: MSC-Based Clinical Trials by Phase of Development, 2020 PAGEREF _Toc61012485 \h 99TABLE 9.9: Number of COVID-19 Clinical Trials by Country PAGEREF _Toc61012486 \h 101TABLE 9.10: Examples of Clinical Trials involving MSC-Derived Exosomes PAGEREF _Toc61012487 \h 102TABLE 9.11: NIH Funding for Research on MSCs, 2020 PAGEREF _Toc61012488 \h 103TABLE 9.11: (CONTINUED) PAGEREF _Toc61012489 \h 104TABLE 9.12: CIRM-Funded MSC Projects PAGEREF _Toc61012490 \h 105TABLE 9.13: MSC-Based Clinical Trials Funded by CIRM PAGEREF _Toc61012491 \h 106TABLE 10.1: Examples of Bioengineered MSCs Loaded with Therapeutics PAGEREF _Toc61012492 \h 110TABLE 10.2: Examples of Bioengineered MSCs used as Anti-Cancer Trojan Horses PAGEREF _Toc61012493 \h 111TABLE 11.1: Select Cases of Modified MSC Applications and Therapeutic Outcome PAGEREF _Toc61012494 \h 121TABLE 12.1: Select MSC-Based Clinical Trials for Autoimmune Diseases PAGEREF _Toc61012495 \h 123TABLE 12.2: Select MSC-Based Clinical Trials for Cardiovascular Diseases PAGEREF _Toc61012496 \h 124TABLE 12.3: Select MSC-Based Clinical Trials for Neurodegenerative Diseases PAGEREF _Toc61012497 \h 125TABLE 12.4: Select MSC-Based Clinical Trials for Bone and Cartilage Diseases PAGEREF _Toc61012498 \h 126TABLE 13.1: Examples of Completed Clinical Trials involving MSCs PAGEREF _Toc61012499 \h 129TABLE 13.2: MSC Products with Marketing Approval PAGEREF _Toc61012500 \h 130TABLE 13.3: Marketed Products Containing MSCs in Matrices PAGEREF _Toc61012501 \h 135TABLE 13.4: Disease Conditions Studied using Stem Cell Conditioned Medium (CM) PAGEREF _Toc61012502 \h 145TABLE 13.5: List of Stem Cell-Based Cosmetics PAGEREF _Toc61012503 \h 146TABLE 13.5: (CONTINUED) PAGEREF _Toc61012504 \h 147TABLE 13.5: (CONTINUED) PAGEREF _Toc61012505 \h 148TABLE 13.5: (CONTINUED) PAGEREF _Toc61012506 \h 149TABLE 13.5: (CONTINUED) PAGEREF _Toc61012507 \h 150TABLE 13.5: (CONTINUED) PAGEREF _Toc61012508 \h 151TABLE 13.5: (CONTINUED) PAGEREF _Toc61012509 \h 152TABLE 14.1: Price Tags of MSC-Based Approved CT Products PAGEREF _Toc61012510 \h 155TABLE 14.2: Price Tags for Select MSC Progenitor-Based Products PAGEREF _Toc61012511 \h 156TABLE 14.3: Global Market for MSC-Based Cell Therapy by Geography, 2020-2027 PAGEREF _Toc61012512 \h 158TABLE 14.4: Global Market for Mesenchymal Stem Cells by Geography, 2020-2027 PAGEREF _Toc61012513 \h 161TABLE 15.1: Alexerion’s Exosome-Based Pipeline PAGEREF _Toc61012514 \h 169TABLE 15.2: BrainStorm’s Product Pipeline PAGEREF _Toc61012515 \h 190TABLE 15.3: Celltex Therapeutics’ Clinical Trials PAGEREF _Toc61012516 \h 195TABLE 15.4: The Cellgram Pipeline from Pharmicell PAGEREF _Toc61012517 \h 239TABLE 15.5: Pluristem’s Clinical Pipeline PAGEREF _Toc61012518 \h 242TABLE 15.6: Sentien’s Pipeline PAGEREF _Toc61012519 \h 253TABLE 15.7: Stemedica’s Clinical Pipeline PAGEREF _Toc61012520 \h 256518795827405About BioInformant: As the first and only market research firm to specialize in the stem cell industry, BioInformant research has been cited by the Wall Street Journal, Nature Biotechnology, Xconomy, and Vogue Magazine. Serving Fortune 500 companies that include Pfizer, GE Healthcare, and Goldman Sachs, BioInformant is your global leader in stem cell industry data. To learn more, visit . BioInformant Worldwide, LLC00About BioInformant: As the first and only market research firm to specialize in the stem cell industry, BioInformant research has been cited by the Wall Street Journal, Nature Biotechnology, Xconomy, and Vogue Magazine. Serving Fortune 500 companies that include Pfizer, GE Healthcare, and Goldman Sachs, BioInformant is your global leader in stem cell industry data. To learn more, visit . BioInformant Worldwide, LLC ................
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