MONT-SAINT-GUIBERT, Belgium — Cellistic, a pioneer in iPSC-based off-the-shelf cell therapy development and manufacturing services, announces the launch of its Allo Chassis™—ready-to-use, immune-cloaked iPSC cell lines derived from CD34+ and CD4+ T-cell primary cells. These innovative cell lines represent a substantial leap forward in cell line development, effectively reducing both timelines and costs. Leveraging Cellistic’s extensive expertise in iPSCs, including in the development of T-cell based treatments, the Allo Chassis™ cell lines set a new standard in the cell therapy market with their unprecedented technology, developed in accordance with current Good Manufacturing Practice (cGMP) standards. [Read more…]
Academic and Medical CDMOs Serving the Cell Therapy Industry
In addition to commercial cell therapy CDMOs, there are other industry players that support the cell therapy industry, including academic and medical CDMOs. While these groups do contribute to the cell therapy CDMO market, their manufacturing capabilities are limited in scale and best suited to small, early-stage clinical trials. [Read more…]
The Science of Longevity: Compounds and Strategies to Optimize Cholesterol and Cellular Health
High LDL cholesterol (often referred to as “bad cholesterol”) is a major risk factor for cardiovascular disease, which remains the leading cause of death worldwide. While statin medications are a cornerstone of conventional treatment, many health-conscious individuals and clinicians are exploring natural, evidence-based approaches to support healthy lipid profiles.
In recent years, several natural compounds have gained clinical attention for their ability to lower LDL levels, improve overall cholesterol ratios, and promote cardiovascular wellness. [Read more…]
Cook MyoSite Announces Completion of Enrollment for the CELLEBRATE Study
Pittsburgh, Pa., February 12, 2025 — Cook MyoSite today announced the completion of enrollment of the CELLEBRATE Study, a Phase III clinical trial evaluating the efficacy and safety of iltamiocel compared to a placebo in the reduction of stress incontinence episode frequency in adult female participants with persistent or recurrent stress urinary incontinence (SUI) despite previous surgical treatment. This milestone builds upon the significance of iltamiocel receiving the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) which recognized the seriousness of this unmet need. [Read more…]
Gameto Announces FDA IND Clearance for Fertilo, the First iPSC-Based Therapy to Enter U.S. Phase 3 Clinical Trials
AUSTIN, Texas — Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Fertilo, to enable the launch of the first US-based Phase 3 clinical trial for an induced pluripotent stem cell (iPSC)-based therapy. This groundbreaking milestone highlights the potential of iPSC technology to address critical unmet needs in reproductive medicine. [Read more…]
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