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.
Regenerative Medicine News & Intelligence Hub
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...
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...
Latest
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.
Verismo Therapeutics to Use Cryoport’s IntegriCell® Cryopreservation Services in its Clinical KIR-CAR T Cell Therapy Programs
Verismo is ramping up its 2 Phase 1s targeting solid tumors and B-Cell non-Hodgkin lymphomas, selecting Cryoport for its cold chain.
CIRM Approves $662M Regen Med Funding, Largest in its History
The California agency is hoping to accelerate the cell & gene therapy industry amid uncertainty about federal funding.
Steminent Filing for Japanese Approval of its Mesenchymal Stem Cell Therapy for Spinocerebellar Ataxia
The company is hoping to be the 2nd Taiwanese cell therapy approved abroad.
UniXell Biotechnology Nabs IND Clearance for its iPSC Parkinsons Therapy, UX-DA003
The Chinese company also received an IND in China a few weeks ago. Supported by good preclinical data, they'll advance clinical trials in both countries soon.
First Patient Dosed in Neural Stem Cell Therapy for Huntington’s Trial at UCI Health
The embryonic-derived cell therapy is implanted directly into the brain, and this early trial hopes to establish safety and baseline efficacy.
China Launches Huge Umbilical Stem Cell Longevity RCT
PLA General Hospital has begun recruiting 2,000 adults aged 50 and older for a multicenter randomized trial to assess whether an approved umbilical cord mesenchymal stem cell therapy can safely improve aging-related...
CARsgen Nabs Chinese Approval of Satri-cel, its CAR-T Therapy for Stomach Cancer
Based on the RCT results published in The Lancet, the Chinese biotech company has received approval for the world's first CAR-T for solid tumors.
Hope Biosciences Publishes Positive Results from Stem Cells for TBI Study
The published Phase I/IIa study found that MSC therapy reduced markers of brain inflammation and improved depression, fatigue, pain, and imaging biomarkers in adults with chronic traumatic brain injury, supporting ongoing larger...
REPROCELL Receives Commercialization Award from Maryland Stem Cell Research Fund to Advance Universal, Hypoimmune iPSC Platforms
The award will fund REPROCELL’s development of clinical-grade lines and a modular gene insertion platform designed to improve scalability, regulatory readiness, and access to off-the-shelf cell therapies.
FDA Unveils its Plan for Operation TrialBlazer, Hoping to Streamline Drug Development Timelines
The FDA outlined a broad set of new pilot programs, guidance updates, and support resources to streamline drug development from first-in-human studies through pivotal trials while reducing unnecessary regulatory burden and improving...
FDA Reverses Decision on Regenxbio’s Gene Therapy for Hunter’s Syndrome, Supporting BLA Resubmission for Accelerated Approval
REGENXBIO said the FDA will consider existing longer-term data for NAVSUNLI under the accelerated approval pathway without requiring new studies, allowing the company to target a BLA resubmission in Q3 2026.
