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

Truway Health, Inc.

Status and phase: Invitation-only; Early Phase 1

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

Treatments: Other: Normothermic Cell Culture Control; Other: Standard Laboratory Cryopreservation Procedure; Other: Enhanced Laboratory Cryopreservation Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT07321028

TWH-CRYO-IVT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Standard Cryopreservation Protocol (In Vitro)

Experimental group

Description:

Human-derived cell samples are processed using a conventional laboratory cryopreservation protocol to establish baseline post-thaw viability and cellular recovery metrics.

Treatment:

Other: Standard Laboratory Cryopreservation Procedure

Enhanced Cryotherapeutic Cryopreservation Protocol (In Vitro)

Experimental group

Description:

Human-derived cell samples are processed using an optimized cryopreservation protocol designed to reduce cryo-induced cellular injury and improve post-thaw functional recovery.

Treatment:

Other: Enhanced Laboratory Cryopreservation Procedure

Normothermic Cell Culture Control (No Cryopreservation)

Sham Comparator group

Description:

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.

Treatment:

Other: Normothermic Cell Culture Control