The new frontier: the bioanalysis of cell and gene therapies
RegMedNet
by Megan Giboney
1d ago
Our sister site Bioanalysis Zone has launched a new podcast series to explore the important role of bioanalysis in cell and gene therapies!  Cell and gene therapies are comprised of multiple elements including living cells or viral vectors and therefore pose additional bioanalytical challenges compared with chemical or biological drugs. The capability of bioanalytical methods to monitor cell and gene therapy safety and efficacy plays a significant role in the therapy’s success. In this six-part series, Ellen Williams, Digital Editor of Bioanalysis Zone, is joined by industry experts expl ..read more
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Regenerating damaged heart tissue with stem cell bioimplants
RegMedNet
by Megan Giboney
6d ago
A first-in-human clinical trial has demonstrated that PeriCord, a novel bioimplant to stimulate the regeneration of damaged heart tissue, is safe and tolerable, with early indications of anti-inflammatory properties. When patients suffer a myocardial infarction (more commonly known as a heart attack), they are left with scar tissue in the affected area of their heart. While this helps to retain the existing heart structure, the scar tissue does not possess many of the key mechanical properties of original cardiac tissue, resulting in impaired cardiac function. Advanced therapy products utiliz ..read more
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Cell therapy weekly: CARVYKTI gets FDA approval for second-line treatment of multiple myeloma
RegMedNet
by Megan Giboney
6d ago
This week: Ascend Advanced Therapies (London, UK) acquired GMP manufacturing capacity in Florida, Charles River Laboratories International (MA, USA) and Axovia Therapeutics (London, UK) announced a collaboration to develop and manufacture gene therapies for ciliopathies and The US FDA has expanded the use of CARVYKTI® as an earlier treatment for multiple myeloma.  The news highlights: Ascend expands expertise and GMP capabilities Collaboration to advance gene therapies for ciliopathies CARVYKTI gets US FDA approval for second-line treatment of multiple myeloma Ascen ..read more
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Novel bioengineering approach for ear reconstruction
RegMedNet
by Megan Giboney
1w ago
Researchers have combined 3D printing and tissue engineering techniques to create a replica of an adult human ear that resembles its shape, size and biomechanical properties. Ear reconstruction surgery remains a challenging procedure for surgeons, attributable to the surgical precision and skill required, as well as the hurdles associated with obtaining the autologous costal cartilage for the scaffold and creating a graft that closely resembles the recipient’s other ear. Advancements in 3D modeling, 3D printing and tissue engineering have meant that a team of researchers from Weill Cornell Me ..read more
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Cell therapy weekly: Evaluating CLIP-CAR technology in NK cells
RegMedNet
by Megan Giboney
2w ago
This week: Xcell Biosciences (CA, USA) has expanded its research collaboration with Labcorp (NC, USA), Cartherics (Notting Hill, Australia) and TiCARos (Seoul, South Korea) will assess TiCARos' CLIP-CAR technology in natural killer (NK) cells and Obsidian Therapeutics (MA, USA) has secured US$160.5 million in Series C financing to advance it's tumor infiltrating lymphocyte (TIL) program. The news highlights: Xcell Biosciences and Labcorp expand collaboration Evaluating CLIP-CAR technology in NK cells Obsidian secures US$160.5 million to advance TIL program Xcell Biosciences and Labcorp expa ..read more
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Promising results: gene therapy for giant axonal neuropathy shows early benefits
RegMedNet
by Megan Giboney
2w ago
An early-stage clinical trial for a new gene therapy to treat giant axonal neuropathy – a genetic disease affecting children – has demonstrated promising indications that the approach could work. A recently concluded early-phase clinical trial at the National Institutes of Health (MD, USA) has demonstrated initial signs of success for a new gene therapy for children suffering from giant axonal neuropathy (GAN). The treatment, which is injected directly into the spinal fluid, could help to slow the progression of GAN and reduce its clinical symptoms. GAN is a rare, inherited genetic disease th ..read more
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Top 3 grants in regenerative medicine: March 2024
RegMedNet
by Megan Giboney
2w ago
This month’s top grants in regenerative medicine, sourced from Dimensions, include projects on investigating the role of CD47 in hindering the removal of dysfunctional aged muscle stem cells to enhance muscle regeneration in older individuals, developing allogeneic pluripotent stem cell-derived photoreceptors to treat retinal disease and enhancing bone regeneration following tumor resection. Check out this month’s top grants in regenerative medicine: Targeting CD47 to enhance muscle regeneration in aging Pluripotent stem cell-derived photoreceptors to treat retinal disease Enhancing bone reg ..read more
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Cell therapy weekly: Clinical Trial Application approval for muscular dystrophy gene therapy
RegMedNet
by Megan Giboney
3w ago
This week: Slingshot Bio (CA, USA) launched a portfolio of products to tackle quality control challenges in cell therapy development and manufacturing, Aaron Ondrey has been appointed Chief Financial Officer of Rocket Pharmaceuticals (NY, USA) and Atamyo Therapeutics (Evry, France) has received approval to initiate a clinical trial investigating its gene therapy for limb-girdle muscular dystrophy. The news highlights: Slingshot Bio launches synthetic cells to improve analytical methodologies for cell therapies Rocket Pharmaceuticals appoints new Chief Financial Officer Clinical trial to comm ..read more
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Regenerative Medicine Highlights: January – March 2024
RegMedNet
by Megan Giboney
3w ago
Journal Development Editor, Jasmine Hagan, shares her top papers from the January, February and March issues of Regenerative Medicine. With quarter one now at an end, 2024 commenced on a promising note marked by an array of articles published covering topics including bioprinting in tissue engineering, bioengineering and mesenchymal stem cell therapy. In this feature, I share some of my top articles from issues 1, 2 and 3 of Volume 19, providing a snapshot of some of the most exciting work in the field, published in Regenerative Medicine. Experimental and computational approach to establish f ..read more
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Process optimization: a tool to widen cell therapy access
RegMedNet
by Megan Giboney
3w ago
Robert (Robb) Richards is the Corporate Director of The Center for Cell Therapy and Transplant at the University of Pennsylvania (PA, USA). For the past 7+ years, Robert has overseen both commercial and research arms of the program. At Advanced Therapies Week 2024 (16–19 January; Miami, Florida), Robb talked to us about how cell therapies are largely inaccessible for community hospitals and how this is being addressed by Penn Medicine’s Abramson Cancer Center, which is using data-driven process optimization to foster collaboration between community healthcare organizations and cell therapy de ..read more
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