Evaluation of In-Vitro Cryo Therapeutic Intervention on Human Cellular Samples - Truway Health Cryogenics Pilot Study
概览
- 阶段
- 早期 1 期
- 状态
- Enrolling By Invitation
- 发起方
- Truway Health, Inc.
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post-Thaw Viability
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an in-vitro laboratory protocol with no human participants. All interventions are openly assigned to specimen groups; therefore, no masking is required.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard Laboratory Cryopreservation Procedure (Other)
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.
干预措施: Enhanced Laboratory Cryopreservation Procedure (Other)
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.
干预措施: Normothermic Cell Culture Control (Other)
结局指标
主要结局
Post-Thaw Viability
时间窗: Twenty-four (24) hours after thaw
Percentage of viable cells determined by trypan blue exclusion assay or automated cell viability analyzer.
次要结局
- Cell Proliferation and Long-Term Viability at 7 Days(Seven (7) days after thaw)
- Apoptosis and Necrosis Marker Expression at 24 and 72 Hours(Twenty-four (24) hours and seventy-two (72) hours after thaw)
- Cellular Metabolic and Functional Integrity from 24 Hours to 7 Days(From twenty-four (24) hours through seven (7) days after thaw)
- Morphological Integrity at 24 Hours(Twenty-four (24) hours after thaw)