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OpCT-001 is the first iPSC-derived investigational cell therapy to be clinically tested for treating primary photoreceptor diseases
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Phase 1/2a trial, CLARICO, is a first-in-human, multisite, 2-part interventional trial to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001
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Primary photoreceptor diseases are a subgroup of inherited retinal disorders that affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in children and adults
uBriGene Launches Clinical iPSC Banks to Accelerate Regenerative Medicine and Cell Therapy Development
ROCKVILLE, MD, June 16, 2025 – uBriGene Biosciences, a leading cell and gene therapy CDMO, is proud to announce the launch of its fully characterized, ready-to-use induced pluripotent stem cell (iPSC) banks. Developed using uBriGene’s proprietary RNA-LNP reprogramming technology, these iPSC banks are now available to support research, translational development, and clinical applications worldwide. [Read more…]
iPSC Technology Grows Even More Powerful and Disruptive
Since the discovery and development of induced pluripotent stem cell (iPSC or iPS cell) technology a decade ago, significant progress has been made within stem cell biology and regenerative medicine. In recent years, iPSCs have been used extensively in disease modeling, drug discovery, and cell therapy applications. Importantly, new pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and clinical trials employing human iPSC-derived cell types have been initiated. [Read more…]
Vita Therapeutics and I Peace announced a development program to generate iPS- derived differentiated cells for transplant therapy with an initial focus on FSHD (Facioscapulohumeral Muscular Dystrophy) using universal iPS cells
Palo Alto, CA, July 10, 2025 –Â Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the company has agreed with Vita Therapeutics (Vita) to jointly develop universal iPS cells that will be used for cell transplantation therapy.
GMP-grade iPS cells will be modified with proprietary, licensed gene editing technology to make a base platform hypoimmune line where Class I and II HLA genes that determine rejection have been depleted. These hypoimmune lines can be further customized in I Peace cGMP facilities. [Read more…]
Cellino’s iPSC Manufacturing Technology Receives FDA Advanced Manufacturing Technology (AMT) Designation
AMT Designation Positions Cellino to Accelerate the Development of Scalable, Personalized Regenerative Medicines
CAMBRIDGE, Mass. — Cellino, a leader in advanced biomanufacturing, today announced that its optical biomanufacturing technology for generating induced pluripotent stem cells (iPSCs) has received the FDA’s Advanced Manufacturing Technology (AMT) designation from the Center for Biologics Evaluation and Research (CBER). This prestigious designation highlights the transformative potential of Cellino’s automated technology for scaling up high-quality iPSCs to industrialize next-generation regenerative therapies. [Read more…]
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