Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)

Conditions

• Biomechanical Injury Modeling (In-Vitro)
• Blunt Force Injuries to the Extremities (Cellular Injury Model)
• Cellular Injury and Post-Cryogenic Recovery
• Cellular Regeneration and Repair
• Cold-Induced Cellular Injury
• Cryogenic Cellular Stress
• Hypothermic Tissue Stress
• Osmotic Stress Injury
• Post-Thaw Viability Impairment
• Thermal Injury Response
• Tissue Damage and Recovery Pathways

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard Laboratory Cryopreservation Procedure — OTHER
  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.
• Enhanced Laboratory Cryopreservation Procedure — OTHER
  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.
• Normothermic Cell Culture Control — OTHER
  Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.

Study Details

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.

Key Dates

Start date

Dec 10, 2025

Status verified

Dec 2025

Primary completion

Dec 10, 2066

Completion

Dec 10, 2066

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Standard Cryopreservation Protocol (In Vitro)
  Human-derived cell samples are processed using a conventional laboratory cryopreservation protocol to establish baseline post-thaw viability and cellular recovery metrics.
• Experimental: Enhanced Cryotherapeutic Cryopreservation Protocol (In Vitro)
  Human-derived cell samples are processed using an optimized cryopreservation protocol designed to reduce cryo-induced cellular injury and improve post-thaw functional recovery.
• Sham Comparator: Normothermic Cell Culture Control (No Cryopreservation)
  Human-derived cell samples are maintained under standard normothermic cell culture conditions without exposure to freeze-thaw cycles to serve as a baseline control for cellular viability and function.

Primary Outcome Measure

Post-Thaw Viability [ Time Frame: Twenty-four (24) hours after thaw ]

Locations (1)

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