Inicial Request Agreement with Researchers of ANMAT, (Argentinean FDA), to Present Clinical Trials to Obtain Approval and Registers of Complex Manipulated Cellular Therapy Products and Products to be used in Tissue Engineering

Conclusion MethodsThe main obstacle for clinical trial regulators was the lack of information of how to homologate the knowledge of Drug Characterization, Pharmacokinetics, Pharmacodynamics and Safety the analogic study for cellular products.To approach this problem Center for Research on Tissue Engineering and Cellular Therapy (CIITT) presented a full documentation for a clinical trial. It was written following FDA recommendations and theoretical concepts, presented during the Global Regulatory Perspective (GRP) annual conferences.Then, a careful discussion with the regulators was sustained, satisfying all the concerns that they had it.ResultsThe University Ethical Committee (Equivalent to the US IRB) took almost a year to provisionally approved this package of documents, because its definitive approval was pending under ANMAT approval.Then, with the provisional approval the papers were presented to ANMAT. The parallel explanation on characterization, pharmacokinetic, pharmacodynamics and safety of a DRUG with a Cellular Product was accepted. On this common ground, they asked for specific preclinical experiments for the data on the specific cellular products presented. Briefly, ANMAT asked for the Specific Identity, Purity, Potency and Safety. The Safety also included CMC process, animal oncogenicity, induction of autoimmunity, and organ toxicity (Anatomo-pathology organ analysis and serologic toxicity detection. The studied were done in disease animal models, using same rou...
Source: Cytotherapy - Category: Cytology Source Type: research