{"id":"W4406717522","doi":"10.3389/fphar.2024.1486812","title":"Brief summary of the regulatory frameworks of regenerative medicine therapies","year":2025,"lang":"en","type":"review","venue":"Frontiers in Pharmacology","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":22,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"National Research Foundation of Korea; Ministry of Food and Drug Safety; National Research Foundation","keywords":"Regenerative medicine; European union; Regulatory science; Medicine; Political science; Engineering ethics; Business; Engineering; Biology; International trade; Stem cell; Pathology; Genetics","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.002799437,0.001333789,0.001171959,0.004046709,0.000926583,0.002674294,0.001101276,0.002521663,0.006598924],"category_scores_gemma":[0.004108671,0.000478243,0.0009201189,0.0044634,0.001546968,0.003305851,0.001253891,0.004397766,0.002410386],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002559802,"about_ca_system_score_gemma":0.005611225,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003922905,"about_ca_topic_score_gemma":0.004722657,"domain_scores_codex":[0.9987347,0.0003708449,0.0002167489,0.0001915029,0.0003963503,0.00008987945],"domain_scores_gemma":[0.9974022,0.001838013,0.0002717577,0.00005270465,0.00036563,0.00006972616],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00005306244,0.00009472998,0.0002093577,0.03290102,0.00006083807,0.0002990941,0.0005597259,0.0009003786,0.001138984,0.1683225,0.1181559,0.6773044],"study_design_scores_gemma":[0.000003265361,0.00002567284,0.0003184212,0.007956042,0.00002782742,0.0003510615,0.00008497774,0.00006432743,0.0001174654,0.007376952,0.9836603,0.00001362943],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0001355358,0.986744,0.0006031721,0.002503483,0.001111708,0.00002269322,0.00007063658,0.00001290412,0.008795814],"genre_scores_gemma":[0.001424186,0.9929085,0.000708091,0.002282113,0.0007362642,0.0000319811,0.00009065354,0.00000514584,0.001813146],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.006598924,"threshold_uncertainty_score":0.02207559,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02520681270105729,"score_gpt":0.3704947589031254,"score_spread":0.3452879462020681,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}