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Cabaletta Bio Reports One-Year Rese-cel Responses in Dermatomyositis and Safety Profile Across 71 Autoimmune Disease Patients
Across 71 patients with four autoimmune diseases, 94% experienced no or Grade 1 cytokine release syndrome and 96% had no immune effector cell-associated neurotoxicity syndrome.
New Trial – Mesenchymal Stem Cell Exosomes for Non-Dialysis Chronic Kidney Disease
The randomized, participant-blinded trial enrolled 34 adults with stage 3–4 kidney disease to compare two intravenous exosome regimens with saline placebo, alongside standard care.
New Trial – Collagen Scaffold for Repair of Talus Cartilage Injury
Beijing Jishuitan Hospital plans to randomly assign 40 adults whose symptoms persisted despite conservative treatment to receive microfracture surgery with or without a collagen scaffold.
Xylyx Bio Announces FDA Orphan Drug Designation and NIH Grant for Investigational Human Whole-Lung Graft
The $2,999,266 award will support two years of safety and feasibility research, including planned first-in-human transplantation studies of the investigational graft.
Pluri and ZEO ScientifiX Team Up to Expand U.S. Regenerative Medicine Manufacturing and Commercialization
Pluri would own 50% of ZEO at closing, which is expected in the fourth quarter of 2026 and remains subject to approvals and other conditions.
Darwin Biotechnology Enrolls First Patient in Phase II Trial of MSC-Derived Protein Complex for Persistent Neurological Deficits After Ischemic Stroke
Darwin’s platform uses stress induction to stimulate mesenchymal stem cells to release targeted protein complexes; the investigational treatment contains no cells or exosomes.
Made Scientific and CARR Biosystems Partner on Single-Use Centrifugation for Cell Therapy Manufacturing
At its East Norriton facility, Made Scientific will use the systems to harvest, wash and concentrate cells alongside 3D bioreactors of up to 200 liters.
BioCardia Advances Helix Catheter Toward FDA Marketing Clearance With De Novo Pre-Submission Acceptance
The FDA reviewed BioCardia’s initial De Novo pre-submission package in May 2026 and, according to the company, raised no concerns regarding the Helix catheter’s safety data, performance, or compatibility with general classes of agents.
iReprogram Named Lead Industry Partner in University of Michigan’s New Cell Reprogramming Initiative for Diabetes
The public–private effort will apply AI to refine the company’s cell reprogramming discovery engine and expand validation across additional diabetes-related cell types.
Kyverna Therapeutics Reports One-Year Phase 2 Results for CAR T-Cell Therapy in Stiff Person Syndrome
The study enrolled 26 adults who had responded inadequately to at least one immunotherapy, testing a single dose without a comparison group.
Porton Advanced and Ascist Biotech Partner to Advance IND Submission in China for Adult Pancreatic Progenitor Cell Therapy for Diabetes
The therapy uses a patient’s own adult pancreatic progenitor cells, expanded and differentiated in vitro then reinfused without immunosuppression.
XellSmart’s iPSC-Derived Dopaminergic Neural Progenitor Cell Therapy Shows Motor Improvements in Phase I Parkinson’s Trial and Completes Phase II Enrollment
All nine Phase I participants received transplants into the bilateral posterior putamen, and serial MRI monitoring showed no aberrant cellular overgrowth or tumor formation.
Fate Therapeutics Presents Updated Preliminary Data on iPSC-Derived CAR-T for Active Lupus Nephritis
In the ongoing Phase 1 study, both patients evaluated six months after FT819 and preparatory bendamustine treatment met criteria for a kidney response.
Octane Biotech and Currus Biologics Automate CAR T-Cell Therapy Manufacturing
The closed production process reduced hands-on work and viral vector use per batch, lowering costs ahead of CUR-001’s first human trial.
Amish-Backed Gene Therapy Company, Plowshare Therapies, Raises $6.7 Million
The funding will support manufacturing, safety testing and regulatory preparations for an experimental gene therapy targeting types 1A and 1B of Maple Syrup Urine Disease.
PBS Biotech Teaming Up With Rockwell Automation to Scale Up Cell Therapy Development
The MiniPRO platform runs up to 24 independently controlled bioreactors in parallel, letting developers test processes with automation designed to integrate into larger manufacturing systems.
Boston Children’s Hospital Launches Consortium to Develop Bioengineered Heart Tissues for Children
Researchers plan to test the engineered tissues first in the laboratory and then in large animals, and eventually in humans.
BrightPath Presents Preclinical Data and Phase 1 Trial Design for iPSC-Derived CAR-iNKT Therapy for Multiple Myeloma
The planned trial is designed for patients whose multiple myeloma has returned or resisted treatment after at least three prior lines of therapy.
Century Therapeutics Reports Sustained Glucose Control With iPSC-Derived Islets in Diabetic Mice, IND Soon
In rats, islets delivered through the liver’s portal vein had taken hold one month later, supporting the delivery route planned for clinical testing.
Rivercell Launches With $25M to Build AI Models to Predict Human Cell Responses to Drugs and Genetic Changes
The company is developing a purpose-built laboratory platform to collect large-scale training data on how cells change over time and under treatment.
Vitalant Launches Phoenix Cell-Based Analytics Lab to Support Allogeneic Therapy Developers
Developers will have access to immune profiling and detailed donor assessments, intended to help them evaluate the starting material used to make donor-derived cell therapies.
New Trial – Allogeneic Bone Marrow Mesenchymal Stem Cell Injection for Sarcopenia
The phase 1/2 trial plans to enroll 30 participants to assess CG-BM1’s safety and tolerability, with two doses administered one month apart.
Umbilical Cord Mesenchymal Stem Cell Injections Lower Pain Scores More Than Hyaluronate in 50-Patient Severe Knee Osteoarthritis Trial
Participants received either four stem cell injections two weeks apart or five weekly hyaluronate injections, with outcomes tracked for 12 months.
Stempeutics Nabs US Patent for Osteoarthritis Treatment Combining Bone Marrow Stem Cells and Hyaluronic Acid
The Indian biotech company previously published a Phase 3 RCT comparing its therapy to placebo in 146 KOA patients.
Wolwo Bio Subsidiary Receives Chinese Trial Authorization for Umbilical Cord Mesenchymal Stem Cell Therapy for Sepsis
The company hopes to nab the first approval in the world for this indication.