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Набор по приглашению NCT07321028

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

Ранняя фаза I С лечением Cellular Injury and Post-Cryogenic Recovery Cryogenic Cellular Stress Cold-Induced Cellular Injury Thermal Injury Response

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard Laboratory Cryopreservation Procedure, Enhanced Laboratory Cryopreservation Procedure, Normothermic Cell Culture Control.
Кому может быть актуально
Состояния в реестре: Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury, Thermal Injury Response. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of In-Vitro Cryo Therapeutic Intervention on Human Cellular Samples - Truway Health Cryogenics Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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.
  • Другое Normothermic Cell Culture Control
    Cells are cultured continuously under standard laboratory conditions without cryogenic exposure. No cryoprotectants, freezing, or thawing procedures are applied.

Первичные конечные точки

  • Post-Thaw Viability [Срок оценки: Twenty-four (24) hours after thaw]
Вторичные конечные точки (4)
  • Cell Proliferation and Long-Term Viability at 7 Days [Срок оценки: Seven (7) days after thaw]
  • Apoptosis and Necrosis Marker Expression at 24 and 72 Hours [Срок оценки: Twenty-four (24) hours and seventy-two (72) hours after thaw]
  • Cellular Metabolic and Functional Integrity from 24 Hours to 7 Days [Срок оценки: From twenty-four (24) hours through seven (7) days after thaw]
  • Morphological Integrity at 24 Hours [Срок оценки: Twenty-four (24) hours after thaw]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016 — New York

Идентификаторы

NCT: NCT07321028 · TWH-CRYO-IVT-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗