[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07321028":3,"trial-entities:NCT07321028":128,"trial-summary:NCT07321028":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":30,"study_type":41,"primary_purpose":42,"phases":43,"enrollment_info":45,"interventions":48,"primary_outcomes":65,"secondary_outcomes":70,"sex":86,"minimum_age":87,"maximum_age":87,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":102,"locations":106,"central_contacts":115,"overall_officials":116,"references":120,"see_also_links":121},"NCT07321028","TWH-CRYO-IVT-001","Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)","Evaluation of In-Vitro Cryo Therapeutic Intervention on Human Cellular Samples - Truway Health Cryogenics Pilot Study","ENROLLING_BY_INVITATION","2066-12-10","2025-12","2026-01-06","2025-12-10","Truway Health, Inc.","INDUSTRY",true,"This laboratory-based study evaluates the effects of controlled cryogenic preservation on human cell samples using Truway Health's in-vitro cryo therapeutic methodology. The study analyzes post-thaw viability, functional recovery, and morphological integrity following exposure to different cryopreservation parameters. Findings will support optimization of cryogenic protocols intended for future translational, biobanking, and therapeutic applications.","Cryogenic preservation plays a central role in cellular therapy, long-term biological storage, regenerative medicine, and advanced manufacturing of therapeutic cell lines. This study investigates how varying cooling rates, cryoprotectant concentrations, and thaw-recovery procedures influence viability and functionality in human-derived cell samples.\n\nThe intervention consists of laboratory-controlled freeze-thaw cycles at temperatures ranging from -80 °C to -196 °C under defined standard and experimental conditions. Post-thaw evaluations include viability assays, growth kinetics, apoptotic markers, metabolic profiling, and structural assessment.\n\nThe study is non-clinical and does not involve living human subjects. All cell materials are obtained under appropriate consent or supplied as commercially available research-grade lines.",[19,20,21,22,23,24,25,26,27,28,29],"Cellular Injury and Post-Cryogenic Recovery","Cryogenic Cellular Stress","Cold-Induced Cellular Injury","Thermal Injury Response","Post-Thaw Viability Impairment","Osmotic Stress Injury","Biomechanical Injury Modeling (In-Vitro)","Blunt Force Injuries to the Extremities (Cellular Injury Model)","Tissue Damage and Recovery Pathways","Hypothermic Tissue Stress","Cellular Regeneration and Repair",[31,32,33,34,35,36,37,38,39,40],"Cryogenics","Cryopreservation","Freeze-Thaw Damage","Cellular Injury","Thermal Injury","Blunt Force Extremity Injury Model","In-Vitro Damage Response","Post-Thaw Regeneration","Osmotic Stress","Tissue Repair Pathways","INTERVENTIONAL","TREATMENT",[44],"EARLY_PHASE1",{"count":46,"type":47},50,"ESTIMATED",[49,55,60],{"type":50,"name":51,"description":52,"armGroupLabels":53},"OTHER","Standard Laboratory Cryopreservation Procedure","Controlled-rate freezing of human-derived cell samples using an industry-standard cryoprotectant solution (10% dimethyl sulfoxide \\[DMSO\\] in culture medium) and defined cooling curves, followed by liquid nitrogen vapor storage and rapid rewarming. This intervention is conducted entirely in vitro for laboratory evaluation purposes only.",[54],"Standard Cryopreservation Protocol (In Vitro)",{"type":50,"name":56,"description":57,"armGroupLabels":58},"Enhanced Laboratory Cryopreservation Procedure","Modified in-vitro cryopreservation process incorporating alternative cryoprotectant formulations, optimized cooling rates, staged thawing procedures, and post-thaw recovery media adjustments. This protocol is investigational in nature but used solely for laboratory research and comparative performance assessment of cell preservation methods.",[59],"Enhanced Cryotherapeutic Cryopreservation Protocol (In Vitro)",{"type":50,"name":61,"description":62,"armGroupLabels":63},"Normothermic Cell Culture Control","Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.",[64],"Normothermic Cell Culture Control (No Cryopreservation)",[66],{"measure":67,"description":68,"timeFrame":69},"Post-Thaw Viability","Percentage of viable cells determined by trypan blue exclusion assay or automated cell viability analyzer.","Twenty-four (24) hours after thaw",[71,75,79,83],{"measure":72,"description":73,"timeFrame":74},"Cell Proliferation and Long-Term Viability at 7 Days","Cell population doubling time and growth rate calculated from standardized growth curves generated under post-thaw culture conditions.","Seven (7) days after thaw",{"measure":76,"description":77,"timeFrame":78},"Apoptosis and Necrosis Marker Expression at 24 and 72 Hours","Percentage of cells positive for apoptosis or necrosis markers as determined by Annexin V \u002F Propidium Iodide staining or caspase activity assays.","Twenty-four (24) hours and seventy-two (72) hours after thaw",{"measure":80,"description":81,"timeFrame":82},"Cellular Metabolic and Functional Integrity from 24 Hours to 7 Days","Quantitative assessment of cellular metabolic activity and mitochondrial function using validated metabolic assays (e.g., MTT or resazurin reduction assays), and lineage-specific functional markers where applicable.","From twenty-four (24) hours through seven (7) days after thaw",{"measure":84,"description":85,"timeFrame":69},"Morphological Integrity at 24 Hours","Structural integrity and cellular morphology assessed by phase-contrast microscopy and scored using a predefined morphological grading scale.","ALL",null,false,{"inclusion":90,"exclusion":96,"raw_text":101},[91,92,93,94,95],"This study does not enroll human participants. Eligibility applies only to human-derived cell samples.","Samples must be de-identified prior to receipt.","Samples must demonstrate ≥90% viability at pre-freeze assessment.","Samples must be free of contamination (bacterial, fungal, mycoplasma).","Samples must meet chain-of-custody and biospecimen compliance requirements.",[97,98,99,100],"No human participants will be enrolled or contacted.","Any specimen containing identifiable private information.","Samples with inadequate quality, contamination, or compromised viability.","Samples obtained without appropriate donor consent or de-identification certification.","Inclusion Criteria:\n\n* This study does not enroll human participants. Eligibility applies only to human-derived cell samples.\n* Samples must be de-identified prior to receipt.\n* Samples must demonstrate ≥90% viability at pre-freeze assessment.\n* Samples must be free of contamination (bacterial, fungal, mycoplasma).\n* Samples must meet chain-of-custody and biospecimen compliance requirements.\n\nExclusion Criteria:\n\n* No human participants will be enrolled or contacted.\n* Any specimen containing identifiable private information.\n* Samples with inadequate quality, contamination, or compromised viability.\n* Samples obtained without appropriate donor consent or de-identification certification.",[103,104,105],"CHILD","ADULT","OLDER_ADULT",[107],{"facility":108,"city":109,"state":109,"zip":110,"country":111,"geoPoint":112},"Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016","New York","10016","United States",{"lat":113,"lon":114},40.71427,-74.00597,[],[117],{"name":118,"affiliation":13,"role":119},"Gavin Solomon, President & CEO","PRINCIPAL_INVESTIGATOR",[],[122,125],{"label":123,"url":124},"Truway Health, Inc. - Sponsor institution for CRYO-IVT protocol","https:\u002F\u002Fwww.truwayhealth.com",{"label":126,"url":127},"Introduction to cryopreservation principles and cellular responses to freezing","https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fbooks\u002FNBK541103\u002F",{"nct_id":4,"conditions":129,"biomarkers":131},[130],"In Vitro Cellular Study",[],{"nct_id":4,"found":88,"summary":87,"prompt_version":87}]