Industry updates from the field of stem cell research and regenerative medicine in November 2021

References

• 1. Cellectis. Cytovia and Cellectis expand their TALEN^® gene-edited iNK partnership to enable broader collaboration in China (2021). www.cellectis.com/en/press/cytovia-and-cellectis-expand-their-talen-gene-edited-ink-partnership-to-enable-broader-collaboration-in-china/
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• 2. EdiGene. EdiGene enters research collaboration with the University of Wisconsin–Madison on in vivo RNA editing therapies (2021). www.edigene.com/media/73.html
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• 3. EdiGene. EdiGene secures new lab and office space for its growing U.S. R&D center to advance gene-editing based therapies (2021). www.edigene.com/media/69.html
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• 4. EdiGene. EdiGene enters research collaboration to develop gene-editing therapies for inherited retinal degeneration with Peking Union Medical College Hospital (2021). www.edigene.com/media/76.html
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• 5. SanBio. Business partnership for development and commercialization of medical device implant utilizing MSC2 for the regeneration of esophageal tissue in humans (2021). www.sanbio.com/wp/wp-content/uploads/2021/11/20211116_Business-Partnership-for-Development-and-Commercialization-of-Regenerative-Medicine-MSC2.pdf
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• 6. Shoreline Biosciences. Dendreon Pharmaceuticals and Shoreline Biosciences announce CMC and manufacturing alliance to advance the future of iPSC cellular therapy (2021). https://shorelinebio.com/dendreon-pharmaceuticals-and-shoreline-biosciences-announce-cmc-and-manufacturing-alliance-to-advance-the-future-of-ipsc-cellular-therapy/
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• 7. Astellas Pharma. Astellas and Pantherna enter into technology evaluation agreement for research of mRNA-based regenerative medicine (2021). www.astellas.com/system/files/news/2021-11/20211115_en_1.pdf
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• 8. bluebird bio. bluebird bio completes planned business separation (2021). https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-completes-planned-business-separation#
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• 9. CollPlant Biotechnologies. CollPlant announces commercial launch of BioInk Platform with Collink.3D™ for use in 3D bioprinting of human tissues, scaffolds and organs (2021). https://ir.collplant.com/news-events/press-releases/detail/122/collplant-announces-publication-highlighting-its
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• 11. ClinicalTrials.gov. NCT02611609. A phase I/IIstudy to assess MultiStem^® therapy in acute respiratory distress syndrome (MUST-ARDS) (2019). https://clinicaltrials.gov/ct2/show/NCT02611609
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• 12. Bellingan G, Jacono F, Bannard-Smith J et al. Safety and efficacy of multipotent adult progenitor cells in acute respiratory distress syndrome (MUST-ARDS): a multicentre, randomised, double-blind, placebo-controlled phase I/II trial. Intensive Care Med. 48, 36–44 (2022).
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• 13. ClinicalTrials.gov. NCT03807804. Efficacy and safety study of HLCM051(MultiStem^®) for pneumonic acute respiratory distress syndrome (ONE-BRIDGE) (2021). https://clinicaltrials.gov/ct2/show/NCT03807804
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• 14. MiMedx Group. Two new studies demonstrate in vitro bioactivity potential of micronized dehydrated human amnion chorion membrane (MdHACM) to prevent pathological processes underlying osteoarthritis (OA) and tendinopathy (2021). https://mimedx.gcs-web.com/news-releases/news-release-details/two-new-studies-demonstrate-vitro-bioactivity-potential
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• 15. Chung C, Massee M, Koob TJ. Human amniotic membrane modulates Wnt/β-catenin and NF-κβ signaling pathways in articular chondrocytes in vitro. Osteoarthritis Cartilage Open 3, 100211 (2021).
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• 16. Moreno SE, Massee M, Koob TJ. Dehydrated human amniotic membrane regulates tenocyte expression and angiogenesis in vitro: implications for a therapeutic treatment of tendinopathy. J. Biomed. Mater. Res. B Appl. Biomater. (2021).
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• 17. MiMedix Group. Peer reviewed study demonstrates MIMEDX dehydrated human amnion chorion membrane (dHACM) outperforms standard of care in select Mohs defect reconstructions (2021). https://mimedx.gcs-web.com/news-releases/news-release-details/peer-reviewed-study-demonstrates-mimedx-dehydrated-human-amnion
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• 19. SanBio Group SanBio announces publication comparing outcome measures for persons with chronic traumatic brain injury in expert review of neurotherapeutics (2021). www.sanbio.com/pdf/news/_HP_202111_01_en.pdf
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• 20. ClinicalTrials.gov. NCT02416492. A study of modified stem cells in traumatic brain injury (TBI) (STEMTRA) (2021). https://clinicaltrials.gov/ct2/show/NCT02416492
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• 21. SanBio Group. SanBio joins the newly formed national TBI RegistryCoalition (NTRC) as a founding member organization (2021). www.sanbio.com/wp/wp-content/uploads/2021/12/SanBio-Joins-the-Newly-Formed-National-TBI-Registry-Coalition-NTRC-as-a-Founding-Member-Organization.pdf
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• 23. ImStem Biotechnology. ImStem announces first US multiple sclerosis patient has been dosed with its IMS001 (2021). www.imstem.com/index.php?c=category&id=24
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• 24. ClinicalTrials.gov. NCT04956744. A study to evaluate the safety, tolerability, and exploratory efficacy of IMS001 in subjects with multiple sclerosis (2021). https://clinicaltrials.gov/ct2/show/NCT04956744
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• 25. Longeveron. Longeveron announces phase II clinical trial in Japan to test safety and efficacy of Lomecel-B on aging frailty patients (2021). https://investors.longeveron.com/news/News/news-details/2021/Longeveron-Announces-Phase-2-Clinical-Trial-in-Japan-to-Test-Safety-and-Efficacy-of-Lomecel-B-on-Aging-Frailty-Patients/default.aspx
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• 26. ClinicalTrials.gov. NCT03169231. Phase IIb trial to evaluate Longeveron mesenchymal stem cells to treat aging frailty (2021). https://clinicaltrials.gov/ct2/show/NCT03169231
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• 27. Pluristem. Pluristem completes enrollment of its multinational phase III study of muscle regeneration following hip fracture surgery (2021). www.pluristem.com/wp-content/uploads/2021/11/phase-III-Hip-Study-Enrolled-Nov-21.pdf
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• 28. ClinicalTrials.gov. NCT03451916. Treatment of muscle injury following arthroplasty for hip fracture (HF) (2021). https://clinicaltrials.gov/ct2/show/NCT03451916
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• 29. ClinicalTrials.gov. NCT01525667. Safety and efficacy of IM injections of PLX-PAD for the regeneration of injured gluteal musculature after total hip arthroplasty (2015). https://clinicaltrials.gov/ct2/show/NCT01525667
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• 30. Graphite Bio. Graphite Bio enrolls first patient in phase I/II clinical trial of GPH101 for sickle cell disease (2021). https://ir.graphitebio.com/press-releases/detail/60/graphite-bio-enrolls-first-patient-in-phase-12-clinical
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• 31. ClinicalTrials.gov. NCT04819841. Gene correction in autologous CD34⁺ hematopoietic stem cells (HbS to HbA) to treat severe sickle cell disease (CEDAR) (2021). https://clinicaltrials.gov/ct2/show/NCT04819841
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• 32. Humanigen. Humanigen announces clinical trial collaboration to evaluate lenzilumab in acute graft versus host disease (2021). https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-Clinical-Trial-Collaboration-to-Evaluate-Lenzilumab-in-Acute-Graft-Versus-Host-Disease/default.aspx
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• 33. Neuroplast. Dutch stem cell biotech Neuroplast secures € 10million (US$ 11.5million) in series B funding to further advance its transformative stem cell therapy for traumatic spinal cord injury (2021). https://062a517c-8890-4012-ae04-9f771a08c58d.filesusr.com/ugd/6064f5_9e6b9b818e36479480b57b63142fb223.pdf
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• 34. ClinicalTrials.gov. NCT04205019. Safety stem cells in spinal cord injury (SSCiSCI) (2021). https://clinicaltrials.gov/ct2/show/NCT04205019
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• 35. Neuroplast. Dutch stem cell biotech Neuroplast secures € 10million (US$ 11.5million) in series B funding to further advance its transformative stem cell therapy for traumatic spinal cord injury (2021). https://062a517c-8890-4012-ae04-9f771a08c58d.filesusr.com/ugd/6064f5_9e6b9b818e36479480b57b63142fb223.pdf
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• 36. Seres Therapeutics. Seres Therapeutics announces first patient enrolled in phase Ib study of SER-155, an investigational microbiome therapeutic to reduce the risk of antibiotic-resistant bacterial infections and graft-versus-host disease (GvHD) (2021). https://ir.serestherapeutics.com/node/10326/pdf
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• 37. ClinicalTrials.gov. NCT04995653. A multiple dose study to evaluate safety, tolerability, PK, and efficacy of SER-155 in adults undergoing HSCT (2021). https://clinicaltrials.gov/ct2/show/NCT04995653
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• 38. PR Newswire. Taiga initiates phase I/IIclinical study of TBX-2400 in acute myeloid leukemia and myelofibrosis in Croatia (2021). www.prnewswire.com/news-releases/taiga-initiates-phase-12-clinical-study-of-tbx-2400-in-acute-myeloid-leukemia-and-myelofibrosis-in-croatia-301420845.html
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• 39. ClinicalTrials.gov. NCT04709458. Safety and Early Efficacy Study of TBX-2400 in patients with AML or myelofibrosis. https://clinicaltrials.gov/ct2/show/NCT04709458
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• 40. AVROBIO. AVROBIO receives rare pediatric disease designation from the U.S. FDA for AVR-RD-05, a gene therapy for mucopolysaccharidosis Type II (MPSII) or Hunter Syndrome (2021). https://investors.avrobio.com/news-releases/news-release-details/avrobio-receives-rare-pediatric-disease-designation-us-fda-avr
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• 41. CRISPR Therapeutics. CRISPR Therapeutics announces FDA regenerative medicine advanced therapy (RMAT) designation granted to CTX110™ for the treatment of relapsed or refractory CD19⁺ B-cell malignancies (2021). www.crisprtx.com/about-us/press-releases-and-presentations/crispr-therapeutics-announces-fda-regenerative-medicine-advanced-therapy-rmat-designation-granted-to-ctx110-for-the-treatment-of-relapsed-or-refractory-cd19-b-cell-malignancies
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• 42. ClinicalTrials.gov. NCT04035434. A Safety and Efficacy Study evaluating CTX110 in subjects with relapsed or refractory B-cell malignancies (CARBON) (2021). https://clinicaltrials.gov/ct2/show/NCT04035434
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• 43. Longeveron. U.S. Food and Drug Administration approves Longeveron's Lomecel-B for rare pediatric disease designation to treat life-threatening infant heart condition (2021). https://investors.longeveron.com/news/News/news-details/2021/U.S.-Food-and-Drug-Administration-Approves-Longeverons-Lomecel-B-for-Rare-Pediatric-Disease-Designation-to-Treat-Life-Threatening-Infant-Heart-Condition/default.aspx
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• 44. Viacyte. CRISPR Therapeutics and ViaCyte, Inc. to start clinical trial of the first gene-edited cell replacement therapy for treatment of Type 1 diabetes (2021). https://viacyte.com/press-releases/crispr-therapeutics-and-viacyte-inc-to-start-clinical-trial-of-the-first-gene-edited-cell-replacement-therapy-for-treatment-of-type-1-diabetes/
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• 45. AgeX Therapeutics. AgeX Therapeutics receives stock exchange deficiency letter (2021). https://investors.agexinc.com/news/news-details/2021/AgeX-Therapeutics-Receives-Stock-Exchange-Deficiency-Letter/default.aspx
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• 46. bit.bio. bit.bio raises $103million in first close of series B financing (2021). www.bit.bio/news/first-close-of-series-b-financing
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• 47. Clade Therapeutics. Clade Therapeutics raises $87 million series A financing to realize the potential of cell therapy (2021). https://cladetx.com/2021/11/03/clade-therapeutics-raises-87-million-series-a-financing-to-realize-the-potential-of-cell-therapy-2/
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• 48. Immunosoft. Immusoft receives $4M in funding from the California Institute For Regenerative Medicine (CIRM) (2021). www.immusoft.com/2021/11/29/immusoft-receives-4m-in-funding-from-the-california-institute-for-regenerative-medicine-cirm/
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• 49. PR Newswire. Biotech Startup Mekonos raises oversubscribed $25million round to overcome pharma industry's cell & gene therapy delivery hurdles (2021). www.prnewswire.com/news-releases/biotech-startup-mekonos-raises-oversubscribed-25-million-round-to-overcome-pharma-industrys-cell--gene-therapy-delivery-hurdles-301419310.html
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• 50. Ncardia. Ncardia secures $60+ million to enhance and expand leading iPSC offerings (2021). www.ncardia.com/news/ncardia-kiniciti-press-release
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• 51. Pluristem. Pluristem receives approval for grant from the Israel Innovation Authority to develop its next-generation CRISPR PLX platform (2021). www.pluristem.com/wp-content/uploads/2021/11/PSTI-PR-CRISPR-IL-Funding-Announcement-FINAL-FOR-RELEASE.pdf
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• 52. Shoreline Biosciences. Shoreline Biosciences announces $140M financing to advance pipeline of next generation cell immunotherapies (2021). https://shorelinebio.com/shoreline-biosciences-announces-140m-financing-to-advance-pipeline-of-next-generation-cell-immunotherapies/
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