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

Evaluation of In-Vitro Cryo Therapeutic Intervention on Human Cellular Samples - Truway Health Cryogenics Pilot Study

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.

Study Overview

• Status: Enrolling by invitation
• 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
• Intervention / Treatment: Other: Standard Laboratory Cryopreservation Procedure; Other: Enhanced Laboratory Cryopreservation Procedure; Other: Normothermic Cell Culture Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.	Other: Normothermic Cell Culture Control; Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Thaw Viability	Percentage of viable cells determined by trypan blue exclusion assay or automated cell viability analyzer.	Twenty-four (24) hours after thaw

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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.	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.	Twenty-four (24) hours after thaw

Collaborators and Investigators

• Sponsor: Truway Health, Inc.
• Investigators: Principal Investigator: Gavin Solomon, President & CEO, Truway Health, Inc.

Publications and helpful links

Helpful Links

• Truway Health, Inc. - Sponsor institution for CRYO-IVT protocol
• Introduction to cryopreservation principles and cellular responses to freezing

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): December 10, 2066
• Study Completion (Estimated): December 10, 2066

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cryopreservation; Thermal Injury; Cryogenics; Freeze-Thaw Damage; Cellular Injury; Blunt Force Extremity Injury Model; In-Vitro Damage Response; Post-Thaw Regeneration; Osmotic Stress; Tissue Repair Pathways
• Other Study ID Numbers: TWH-CRYO-IVT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study does not involve human participants and does not generate individual participant data (IPD). All data are derived from in-vitro experiments using fully de-identified human-derived cell samples. Therefore, no IPD exists to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes