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. The 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. The 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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.
Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.
Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016
New York, New York, United States
Post-Thaw Viability
Percentage of viable cells determined by trypan blue exclusion assay or automated cell viability analyzer.
Time frame: Twenty-four (24) hours after thaw
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.
Time frame: Seven (7) days after thaw
Apoptosis and Necrosis Marker Expression at 24 and 72 Hours
Percentage of cells positive for apoptosis or necrosis markers as determined by Annexin V / Propidium Iodide staining or caspase activity assays.
Time frame: Twenty-four (24) hours and seventy-two (72) hours after thaw
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.
Time frame: From twenty-four (24) hours through seven (7) days after thaw
Morphological Integrity at 24 Hours
Structural integrity and cellular morphology assessed by phase-contrast microscopy and scored using a predefined morphological grading scale.
Time frame: Twenty-four (24) hours after thaw
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