Common Law Preclusion and Environmental Citizen Suits: Are Citizen Groups Losing Their Standing?

The citizen suit provision of the Clean Air Act (CAA) gives standing to citizen groups to bring suits against private actors for violations of the Act. Congress and the courts have established limitations on a citizen’s ability to bring a claim. These include notification of intent to file, a bar when the EPA or state has already “commenced and is diligently prosecuting” an action, or where the claim is barred by common law preclusion doctrines. In a divided decision, the Tenth Circuit held that the doctrine of issue preclusion barred the filing of a CAA citizen suit in Sierra Club v. Two Elk Generation Partners. The court found that the Sierra Club, the citizen group, was barred from filing a claim even though it was not a party to the previous administrative action. Through an expansive interpretation of the parens patriae doctrine, the Tenth Circuit circumvented the true purpose of the CAA’s citizen suit provisio

Industrial Development of Standardized Fetal Progenitor Cell Therapy for Tendon Regenerative Medicine: Preliminary Safety in Xenogeneic Transplantation

Tendon defects require multimodal therapeutic management over extensive periods and incur high collateral burden with frequent functional losses. Specific cell therapies have recently been developed in parallel to surgical techniques for managing acute and degenerative tendon tissue affections, to optimally stimulate resurgence of structure and function. Cultured primary human fetal progenitor tenocytes (hFPT) have been preliminarily considered for allogeneic homologous cell therapies, and have been characterized as stable, consistent, and sustainable cell sources in vitro. Herein, optimized therapeutic cell sourcing from a single organ donation, industrial transposition of multi-tiered progenitor cell banking, and preliminary preclinical safety of an established hFPT cell source (i.e., FE002-Ten cell type) were investigated. Results underlined high robustness of FE002-Ten hFPTs and suitability for sustainable manufacturing upscaling within optimized biobanking workflows. Absence of toxicity or tumorigenicity of hFPTs was demonstrated in ovo and in vitro, respectively. Furthermore, a 6-week pilot good laboratory practice (GLP) safety study using a rabbit patellar tendon partial-thickness defect model preliminarily confirmed preclinical safety of hFPT-based standardized transplants, wherein no immune reactions, product rejection, or tumour formation were observed. Such results strengthen the rationale of the multimodal Swiss fetal progenitor cell transplantation program and prompt further investigation around such cell sources in preclinical and clinical settings for musculoskeletal regenerative medicine