NCT07321028

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

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Truway Health, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
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.
OTHER	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.
OTHER	Normothermic Cell Culture Control	Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.

Timeline

• Start date: 2025-12-10
• Primary completion: 2066-12-10
• Completion: 2066-12-10
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study