Webinar: Inside eXmoor’s Cell & Gene GMP Facility, Designed for Uncertainty
eXmoor Pharma's experts will present a case study of capabilities and lessons learned scaling its 65,000 foot GMP cell and gene therapy manufacturing center in the UK.
Regenerative Medicine News & Intelligence Hub
Cell & Gene Webinars
Webinar: Reimagining Gene-Modified T Cell Manufacturing – New Data on Integrating Isolation, Activation, Transduction, and Expansion in a Single Quantum Flex™ Workflow
Discover new data showcasing a streamlined approach to gene-modified T cell manufacturing that brings...
Webinar: Inside eXmoor’s Cell & Gene GMP Facility, Designed for Uncertainty
eXmoor Pharma's experts will present a case study of capabilities and lessons learned scaling...
Interviews & Articles
Guts & Glory: Both of Cynata’s iPSC Trials Flop, GVH Phase 2 and KOA Phase 3
Sad day for the industry, here's a summary of the CEO/Executive Chairman's readouts of...
Replacing Magnetic Separation with Buoyancy: A Closer Look at Bracco’s New Cell Selection Platform, BubbleGen™
Could a gentler, more scalable method improve how cells are isolated for advanced therapies?...
Interview: From Zero to One, How Terumo’s Ecosystem Blueprint Is Helping Scale Cell Therapies in Asia
Cell and gene therapies are advancing quickly, but the systems needed to deliver them...
Q&A – Inside iDEM, Mytos’ Automated Cell Therapy Manufacturing Platform
Pluripotent stem cell therapies are expensive, upwards of $500K–$1M per dose. Mytos has developed...
Interview: Veterinary Stem Cells – Gallant’s Quest for the First FDA-Approved MSC Therapy
Gallant is betting the future of veterinary regenerative medicine lies in scalable, well-characterized cell...
Chinese Study Reports Intranasal Muse Stem Cells Show Potential for Parkinson’s Treatment
Researchers report that intranasal Muse cells improved motor function and reduced neurodegeneration in a...
Study Finds Bone Marrow-Derived Stem Cells No Better Than Placebo for Chronic Low Back Pain
The trial found no significant difference in pain or function outcomes between bone marrow...
FDA’s New Regulatory Pathway May Forego RCTs for Ultra-Rare Conditions
Dr. Marty Makary and Dr. Vinay Prasad publish new article in New England Journal...
Interview: siRNA-Loaded Stem Cell Exosomes, Inside NurExone Biologic’s Spinal Cord Injury Candidate
NurExone's SCI candidate showed 100% gait recovery in rat models, and they're gearing up...
Potential Retraction Coming on Pivotal Phase 3 Stem Cell Trial for Heart Failure
What appeared to be a potential stem cell breakthrough is slowly being torn apart...
Inside Japan’s Regenerative Medicine Laws: JSRM Explains
What can the world learn from Japan’s regenerative medicine laws? We sat down with...
All The Latest
iPSC-Derived Heart Cells Show Early Promise in Chinese Heart Failure Trial
HELP Therapeutics’ iPSC-derived cardiomyocytes improved walking distance, myocardial perfusion and heart wall thickening when added to bypass surgery in a 20-patient randomized trial.
Kangstem Biotech’s Stem Cell for Knee Osteoarthritis Phase 2a Reports Significant Results
The Korean biotech company reported improved pain, joint function, and MRI-based structural measures versus placebo at 24 weeks, with no drug-related serious adverse events.
Aspen Neuroscience Nabs FDA RMAT Designation for its Parkinson’s Cell Therapy
The designation gives Aspen added FDA support as it advances sasineprocel, a personalized autologous cell therapy for Parkinson’s disease, through clinical development.
Life Biosciences Doses First Patient in Phase 1 of ER‑100 for Optic Neuropathies, Aiming to Rejuvenate Aging Cells
The trial will assess the safety and tolerability of ER‑100, an epigenetic restoration therapy designed to restore retinal ganglion cell function, while also measuring visual outcomes.
CREATE Medicines to Launch First Phase 1/2 In Vivo Trial of CAR-T Candidate CRT-402 for Autoimmune Diseases in Australia
The approval enables CREATE to start enrolling Australian patients with lupus, systemic sclerosis, and inflammatory myopathies in a first-in-human study of its in vivo CD19-targeted CAR-T therapy, designed to deplete harmful B...
Novo Nordisk Publishes Results from Embryonic Stem Cell-Derived Dopaminergic Cells for Parkinson’s Phase 1/2
The early trial, published in Nature, found that transplanting stem cell-derived dopaminergic progenitor cells into the brains of people with moderate Parkinson’s disease appeared feasible and showed a favorable 12-month safety profile,...
Sonoma Biotherapeutics to Automate its Treg Cell Manufacturing Using Cellares’ Cell Shuttle Platform
The partnership will move Sonoma Biotherapeutics’ Phase 1 autologous CAR-Treg therapy for treatment-resistant rheumatoid arthritis onto Cellares’ automated manufacturing and quality control systems to improve scalability, consistency, and readiness for later-stage development.
Kolon’s Cell-Based Gene Therapy Fails Phase 3 Osteoarthritis Trial
Kolon TissueGene’s phase 3 trial found its osteoarthritis therapy did not improve knee pain or function versus placebo, leaving the biotech to await results from a second late-stage study before deciding the...
Kenai Therapeutics Completes Enrollment of Phase 1b/2a Parkinson’s iPSC Trial
The iPSC-derived neural cell therapy takes its next step in potentially restoring dopaminergic neurons lost to the condition.
MEDIPOST Doses First US Patient in Umbilical Cord Stem Cell Therapy for Knee Osteoarthritis Phase 3
And it begins... the Korean biotech company whose product, Cartistem, has been approved in Korea since 2012, passed Phase 3 in Japan, and is now entering the West.
Cell Therapies to Manufacture CAR-T Therapy for Phase 1/2b Solid Tumor Trial in Australia
The Australian CDMO will manufacture A-SEEDS' therapy for the upcoming trial down under.
Aspen Neuroscience Completes Cohort 3 and 4 Dosing in iPSC-Derived Phase 1/2a for Parkinson’s
The ASPIRO trial of sasineprocel is progressing; fifteen patients have been dosed with the commercial-ready formulation of the autologous cell therapy.
FDA Selects Seven Participants for PreCheck Pilot Program to Advance US Drug Manufacturing
The program is intended to accelerate US drug manufacturing scale-ups and address unmet patient needs. Two companies familiar to our regenerative readers, Cellares and Fujifilm Biotechnologies, made the list!
Orca Bio Nabs FDA Approval of TREGZI, its Cell Therapy for Allogeneic Transplant in Adults with Blood Disorders
Following Phase 3, TREGZI, known as Orca-T, had higher graft-versus-host disease-free survival at one year in patients receiving conventional blood stem cell transplants.
Heartseed Doses First Patient in Historic iPSC-Derived Cardiomyocyte Trial Via Catheter
The company's lead program, HS-001, required open heart surgery, while the new innovation allows for a much simpler, less invasive administration.
