MINNEAPOLIS, MN, December 20, 2023 — Bio-Techne Corporation (NASDAQ: TECH) has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate™ GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), supporting the development and manufacture of regenerative medicine and stem cell therapies. [Read more…]
Recent Breakthroughs in Using Platelet-Rich Plasma (PRP) for Veterinary Applications
Platelet-rich plasma (PRP) therapy is blood plasma that has been enriched with platelets, using a process of standard whole blood collection, followed by anticoagulation (usually with citrate dextrose), and finally, centrifugation. This process separates the platelet-rich plasma (PRP) component of the blood from the red blood cells and other non-therapeutic components, producing a concentrated source of self-derived (“autologous”) platelets as the final PRP product.
This resulting PRP component contains both growth factors and cytokines that may have the ability to support or stimulate the healing of bone, as well as soft tissue structures, such as ligaments, tendons, fascia, and more. While there have not yet been large-scale, controlled clinical trials conducted to evaluate the efficacy of PRP, the procedure has nonetheless become commonplace in medical offices worldwide, most notably, within orthopedic offices. [Read more…]
MESOBLAST Achieves First Ever U.S. FDA Approval of an MSC Therapy (RYONCIL®)
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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
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