Cellular Injury and Post-Cryogenic RecoveryEarly Phase 1CRYO-IVTNCT07321028
Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)
A Early Phase 1 study testing Standard Laboratory Cryopreservation Procedure and Enhanced Laboratory Cryopreservation Procedure in people with Cellular Injury and Post-Cryogenic Recovery and Cryogenic Cellular Stress, run by Truway Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury
- What is being tested?
- Standard Laboratory Cryopreservation Procedure and Enhanced Laboratory Cryopreservation Procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to 10 Dec 2066
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016
New York, New York, 10016
About this study
Official title: 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.
Read the 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.
- Conditions
- Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury, Thermal Injury Response, Post-Thaw Viability Impairment, Osmotic Stress Injury
- Being tested
- Standard Laboratory Cryopreservation Procedure, Enhanced Laboratory Cryopreservation Procedure, Normothermic Cell Culture Control
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Laboratory Cryopreservation ProcedureOther
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 Laboratory Cryopreservation ProcedureOther
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 ControlOther
Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Normothermic Cell Culture Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Thaw Viability
Percentage of viable cells determined by trypan blue exclusion assay or automated cell viability analyzer.
Measured: Twenty-four (24) hours after thaw
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Twenty-four (24) hours after thaw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start10 Dec 2025
- Primary completion10 Dec 2066 (estimated)
- Study completion10 Dec 2066 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cellular Injury and Post-Cryogenic RecoveryStudies of the same condition, open and under way.
- More trials run by Truway Health, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Truway Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gavin Solomon, President & CEO, Principal investigator, Truway Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321028
- Sponsor's protocol ID
- TWH-CRYO-IVT-001
- Acronym
- CRYO-IVT
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of In-Vitro Cryo Therapeutic Intervention on Human Cellular Samples - Truway Health Cryogenics Pilot Study
- ClinicalTrials.gov ID
- NCT07321028
- Acronym / sponsor ID
- CRYO-IVT / TWH-CRYO-IVT-001
- Conditions
- Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury, Thermal Injury Response, Post-Thaw Viability Impairment, Osmotic Stress Injury
- Keywords
- Cryogenics, Cryopreservation, Freeze-Thaw Damage, Cellular Injury, Thermal Injury, Blunt Force Extremity Injury Model, In-Vitro Damage Response, Post-Thaw Regeneration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Truway Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 10 Dec 2066 (estimated)
- Study completion
- 10 Dec 2066 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Cryopreservation Protocol (In Vitro) | Experimental | Other: Standard Laboratory Cryopreservation ProcedureHuman-derived cell samples are processed using a conventional laboratory cryopreservation protocol to establish baseline post-thaw viability and cellular recovery metrics. |
| Enhanced Cryotherapeutic Cryopreservation Protocol (In Vitro) | Experimental | Other: Enhanced Laboratory Cryopreservation ProcedureHuman-derived cell samples are processed using an optimized cryopreservation protocol designed to reduce cryo-induced cellular injury and improve post-thaw functional recovery. |
| Normothermic Cell Culture Control (No Cryopreservation) | Sham comparator | Other: Normothermic Cell Culture ControlHuman-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 may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Laboratory Cryopreservation ProcedureControlled-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. | Other | Standard Cryopreservation Protocol (In Vitro) |
| Enhanced Laboratory Cryopreservation ProcedureModified 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. | Other | Enhanced Cryotherapeutic Cryopreservation Protocol (In Vitro) |
| Normothermic Cell Culture ControlCells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied. | Other | Normothermic Cell Culture Control (No Cryopreservation) |
Primary outcome
Post-Thaw Viability
Time frame: Twenty-four (24) hours after thaw
Percentage of viable cells determined by trypan blue exclusion assay or automated cell viability analyzer.
4 secondary outcomes
Cell Proliferation and Long-Term Viability at 7 Days
Time frame: Seven (7) days after thaw
Apoptosis and Necrosis Marker Expression at 24 and 72 Hours
Time frame: Twenty-four (24) hours and seventy-two (72) hours after thaw
Cellular Metabolic and Functional Integrity from 24 Hours to 7 Days
Time frame: From twenty-four (24) hours through seven (7) days after thaw
Morphological Integrity at 24 Hours
Time frame: Twenty-four (24) hours after thaw
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Truway Health, Inc. - Sponsor institution for CRYO-IVT protocolLink provided by the sponsor.
- Introduction to cryopreservation principles and cellular responses to freezingLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gavin Solomon, President & CEO principal investigator
Truway Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Standard Laboratory Cryopreservation Procedure and Enhanced Laboratory Cryopreservation Procedure in people with Cellular Injury and Post-Cryogenic Recovery and Cryogenic Cellular Stress, run by Truway Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Thaw Viability (time frame: Twenty-four (24) hours after thaw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.