Cryo Therapeutic Protocols for Cell Damage

(CRYO-IVT Trial)

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Truway Health, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Gavin Solomon, President & CEO

Principal Investigator

Truway Health, Inc.

Are You a Good Fit for This Trial?

This trial isn't for people but uses human cell samples to study the effects of cryogenic preservation. It's aimed at improving how cells are frozen and thawed for medical treatments, like healing burns or frostbite.

Inclusion Criteria

Samples must be free of contamination (bacterial, fungal, mycoplasma)

Samples must be de-identified prior to receipt

Samples must demonstrate ≥90% viability at pre-freeze assessment

Exclusion Criteria

Samples with inadequate quality, contamination, or compromised viability

Samples obtained without appropriate donor consent or de-identification certification

No human participants will be enrolled or contacted

What Are the Treatments Tested in This Trial?

Interventions

• In-Vitro Cryo Therapeutic Protocols

Trial Overview

The trial tests two cryopreservation methods on human cell samples: an enhanced lab procedure developed by Truway Health and a standard one. Researchers will compare how well cells recover after being frozen and then thawed.

How Is the Trial Designed?

Group I: Standard Cryopreservation Protocol (In Vitro) Experimental Treatment 1 Intervention

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

Group II: Enhanced Cryotherapeutic Cryopreservation Protocol (In Vitro) Experimental Treatment 1 Intervention

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 III: Normothermic Cell Culture Control (No Cryopreservation) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Truway Health, Inc.

Lead Sponsor