Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Laboratory Cryopreservation Procedure, Enhanced Laboratory Cryopreservation Procedure, Normothermic Cell Culture Control.
- Who it may be relevant to
- Registry conditions: Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury, Thermal Injury Response. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of In-Vitro Cryo Therapeutic Intervention on Human Cellular Samples - Truway Health Cryogenics Pilot Study
Overview
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.
Interventions
- Other 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. - 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. - Other Normothermic Cell Culture Control
Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.
Primary outcome measures
- Post-Thaw Viability [Time frame: Twenty-four (24) hours after thaw]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016 — New York
Identifiers
NCT: NCT07321028 · TWH-CRYO-IVT-001