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

NCT07321028 | Enrolling By Invitation Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: TWH-CRYO-IVT-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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); Tissue Damage and Recovery Pathways; Hypothermic Tissue Stress; Cellular Regeneration and Repair; Blunt Force Injuries to the Extremities (Cellular Injury Model)

Keywords

Cryogenics; Cryopreservation; Freeze-Thaw Damage; Cellular Injury; Thermal Injury; Blunt Force Extremity Injury Model; In-Vitro Damage Response; Post-Thaw Regeneration; Osmotic Stress; Tissue Repair Pathways

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cell Proliferation and Long-Term Viability at 7 Days

  Seven (7) days after thaw

• Apoptosis and Necrosis Marker Expression at 24 and 72 Hours

  Twenty-four (24) hours and seventy-two (72) hours after thaw

• Cellular Metabolic and Functional Integrity from 24 Hours to 7 Days

  From twenty-four (24) hours through seven (7) days after thaw

• Morphological Integrity at 24 Hours

  Twenty-four (24) hours after thaw

Study Arms (3)

Standard Cryopreservation Protocol (In Vitro)

EXPERIMENTAL

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

Enhanced Cryotherapeutic Cryopreservation Protocol (In Vitro)

EXPERIMENTAL

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

Normothermic Cell Culture Control (No Cryopreservation)

SHAM COMPARATOR

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

Interventions

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.

Enhanced Cryotherapeutic Cryopreservation Protocol (In Vitro)

Normothermic Cell Culture Control OTHER

Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.

Normothermic Cell Culture Control (No Cryopreservation)

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.

Standard Cryopreservation Protocol (In Vitro)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Truway Health, Inc.: lead

Study Sites (1)

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

New York, New York, 10016, United States

Location

Related Links

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

Study Officials

• Gavin Solomon, President & CEO

  Truway Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an in-vitro laboratory protocol with no human participants. All interventions are openly assigned to specimen groups; therefore, no masking is required.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment of human-derived cell samples into multiple intervention groups, including standard cryogenic freeze-thaw protocol, enhanced cryo-therapeutic protocol, and normothermic control. Each group is processed independently and concurrently to evaluate post-thaw viability, cellular injury response, and functional recovery.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 6, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 10, 2066
• Study Completion (Estimated): December 10, 2066
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)