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

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.

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

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.

Sponsors & Collaborators

• Truway Health, Inc.

  lead INDUSTRY

Principal Investigators

• Gavin Solomon, President & CEO · Truway Health, Inc.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-10

Primary Completion

2066-12-10

Completion

2066-12-10

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations