Cord Blood Cells Showed Modest Benefits in Autism Trial
A small trial tested whether repeated donor cord blood cell infusions could safely influence social symptoms in children with autism and blood signs of immune dysregulation.
A small trial tested whether repeated donor cord blood cell infusions could safely influence social symptoms in children with autism and blood signs of immune dysregulation.
The analyses track skeletal muscle and heart outcomes through 24 months in 82 of 106 randomized participants, including delayed-start and natural-history comparisons submitted with a regulatory amendment.
The combined company operates 16 qualified manufacturing suites across three U.S. sites, supporting cell therapy programs from early development through commercial supply.
In mice with collagen-induced arthritis, several ERNA-201 candidates lowered disease severity versus untreated controls, while the company shifts near-term spending to ERNA-101’s planned ovarian cancer trial filing.
The project will test whether GenomeFrontier’s virus-free process, including electroporation-based transfection, can be adapted to Cellares’ automated system to support U.S. clinical manufacturing.
The approval was based on a trial comparing 17 treated children with 27 untreated peers, with follow-up extending to nearly eight years and shipments expected within 30 to 60 days.
The move is aimed at helping providers meet the new states’ rules on sourcing, consent, documentation and safety reporting, which do not replace federal requirements or FDA approval.
In the 40-infant randomized, double-blind trial, patients received a single intramyocardial dose. It did not improve right ventricular ejection fraction at 12 months.
Backed by $6.4M in grants, the team will create and validate more than 20 patient-derived stem cell lines, then share the cells, protocols and data publicly.
The designation was based on early U.S. trial data in spinal cord injury patients, where this non-replicating HSV-1 gene therapy is being tested as a single-course treatment aimed at reducing bladder overactivity...