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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2066-12-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an in-vitro laboratory protocol with no human participants. All interventions are openly assigned to specimen groups; therefore, no masking is required.

Study Groups

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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.

Group Type EXPERIMENTAL

Standard Laboratory Cryopreservation Procedure

Intervention Type 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 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.

Group Type EXPERIMENTAL

Enhanced Laboratory Cryopreservation Procedure

Intervention Type 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 (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.

Group Type SHAM_COMPARATOR

Normothermic Cell Culture Control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Normothermic Cell Culture Control

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

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No