Presently, MSC-based clinical trials are being conducted for a range of disease conditions, with many completed trials showing safety and efficacy. Clinical utility of MSCs is primarily attributed to their four key biological properties, which include: [Read more…]
Athersys Provides MultiStem Clinical Update
Enrollment completed in second cohort of MATRICS-1 trial in hemorrhagic trauma
Enrollment reaches halfway mark in MASTERS-2 trial in ischemic stroke
CLEVELAND–Athersys, Inc. (Nasdaq: ATHX), a regenerative medicine company developing MultiStem® (invimestrocel) for critical care indications, today provided an update on ongoing clinical trials with MultiStem for the treatment of patients following hemorrhagic trauma (MATRICS-1) and for the treatment of ischemic stroke (MASTERS-2). MultiStem is a proprietary off-the-shelf stem cell product in late-stage clinical trials for acute ischemic stroke, as well as trauma and other inflammatory conditions. [Read more…]
How to find the right end-to-end developer for manufacturing your cGMP-compatible iPSCs
Introduction
From β-islets for diabetes (1) to dopaminergic neurons (Figure 1) for Parkinson’s disease (2), induced pluripotent stem cell (iPSC)-derived, haplotyped, and multiplex-engineered allogeneic cell therapeutics empower the development of effective and safe Cell and Gene Therapy Products (CGTs) that could be manufactured on a large scale in a cost-effective manner and provide a functional cure for diseases that plague humankind today. [Read more…]
Sernova and Evotec on Track to Initiate Clinical Testing of First iPSC-Derived Islets as a Potential Functional Cure for Type 1 Diabetes
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 First iPSC-derived commercially viable off-the-shelf islet combination product is advancing towards regulatory filing in 2024 for anticipated clinical trial authorization to treat patients with Type 1 Diabetes (T1D) and severe hypoglycemia
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iPSC islet-like cluster manufacturing scale-up and tech transfer activities are well under way in preparation for first human clinical evaluation
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T1D preclinical models with iPSC derived islet clusters transplanted in Sernova’s Cell Pouch has now demonstrated consistent long-term insulin independence de-risking the combined technologies for both companies
Sartorius collaborates with RoosterBio to advance downstream purification processes for the manufacture of exosomes
Through this collaboration, Sartorius and RoosterBio will provide best-in-class solutions and expertise for a human mesenchymal stem/stromal cell (hMSC) – based exosome production platform that delivers industry-leading yield, purity, and potency.
FREDERICK, Md., Jan. 5, 2023 – The life science group Sartorius extended a strategic collaboration partnership agreement with RoosterBio Inc. (RoosterBio) to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies. Through this collaboration, Sartorius and RoosterBio will provide best-in-class solutions and expertise for a human mesenchymal stem/stromal cell (hMSC) – based exosome production platform that delivers industry-leading yield, purity, and potency. [Read more…]
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