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RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.
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In a single-arm, multi-center, Phase 3 trial of children with steroids-refractory (SR) acute GvHD, 70% achieved an overall response by Day 28 of treatment with RYONCIL, a measure that predicts survival.
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RYONCIL’S immunomodulatory effects, including inhibition of T cell activation and secretion of pro-inflammatory cytokines, position the therapy for potential other indications in diseases with excessive inflammation.
iPSC Market Accelerated by Clinical Studies in Japan, Australia, UK, and U.S.
Growth of the iPSC market is supported by an increasing number of clinical studies that are investigating the therapeutic potential of iPSC-derived cell therapy products. Induced pluripotent stem cells (called iPSCs or iPS cells) are a type of stem cell that can become any cell within the human body, giving them enormous potential for use within regenerative medicine. [Read more…]
Century Therapeutics Progressing CNTY-101, its iPSC-derived CAR NK Cell Candidate, Into a Phase 1 Trial
Represents second IND clearance for CNTY-101, the Company’s lead iPSC-derived CD19-targeted CAR NK cell product candidate, and first in an autoimmune and inflammatory disease indication
Company plans to initiate the Phase 1 clinical trial in the first half of 2024; initial data expected by year-end 2024
CNTY-101 is the first cell therapy product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasion™ technology, IL-15 cytokine support and a safety switch
GMP cell CDMO I Peace, Inc. obtains accreditation as ISO 17025: 2017 compliant
Starts undertaking quality evaluation and characterization of iPSCs in accordance with ISO standards
PALO ALTO, Calif., Dec. 6, 2023 — Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that its Palo Alto quality control testing facility has been accredited as ISO 17025: 2017 compliant. The accreditation was certified by ANSI National Accreditation Board, one of the leading accreditation bodies in the world. The tests in the scope of accreditation center on the characterization of iPSCs and include cell count and viability per USP <1046>, detection of pluripotency marker expression by flow cytometry per USP <1027>, and also by immunofluorescence assay. [Read more…]
Exploring Alternative Treatments for Alleviating Pain from Osteoarthritis
As the years pass, our bodies take on many changes. Some we can control and others, like Osteoarthritis (OA), are a little more out of our hands – but that doesn’t mean you have to let it control you! In this article, we will explore the connection between aging and OA, what causes it, how to manage your symptoms effectively so that you can age gracefully with an active lifestyle. So if you’re ready to get proactive about your health as you age and learn how to best manage the effects of osteoarthritis in your life, then stay tuned for some exciting tips. [Read more…]
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