Cryo Therapeutic Protocols for Cell Damage
(CRYO-IVT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new methods for freezing and thawing cells in the lab, known as In-Vitro Cryo Therapeutic Protocols. Researchers compare different techniques to determine which best preserves cells for future medical research or treatments. They assess cell survival and function after freezing and thawing. This study involves only human cell samples that meet specific quality standards, not direct human participation. As an Early Phase 1 trial, this research aims to understand the initial effects of these protocols, potentially paving the way for future medical advancements.
Will I have to stop taking my current medications?
This study does not involve human participants, so you won't need to stop taking any medications.
What prior data suggests that these cryo therapeutic protocols are safe for human cell samples?
In a previous study, researchers found that changing how cells are frozen and thawed can help prevent damage. They observed that cells showed no harm immediately after thawing and remained healthy for a day afterward. This suggests that the new method of freezing cells, called cryopreservation, may be safe. The study indicated that the cells recovered well after being thawed.
Although this early-stage study mainly focused on safety, the results are promising. The new method might be safer than the usual freezing process. Currently, evidence suggests that the treatment is well-tolerated, but more research is needed to confirm this.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative cryopreservation methods that could significantly improve how we preserve and recover cells after freezing. Unlike standard cryopreservation, which often leads to cell damage during the freeze-thaw process, the enhanced cryotherapeutic protocol aims to minimize this injury and boost cell recovery. By optimizing these techniques, scientists hope to enhance cell viability and function post-thaw, potentially revolutionizing fields like regenerative medicine and transplantation.
What evidence suggests that this trial's cryo therapeutic protocols could be effective for cell damage?
Research has shown that improved cell freezing methods are promising. In this trial, participants will join different study arms to evaluate these methods. The Standard Cryopreservation Protocol arm will establish baseline post-thaw viability and cellular recovery metrics. Meanwhile, the Enhanced Cryotherapeutic Cryopreservation Protocol arm aims to reduce cryo-induced cellular injury and improve post-thaw functional recovery. Studies have found that about 80% of cells survive immediately after thawing, indicating these methods work well. Another study found that recovery rates can reach 98% under certain conditions, suggesting these methods help cells recover better after freezing. This suggests the improved method may protect cells from damage more effectively than standard methods. The goal is to enhance how cells recover and function after being frozen and thawed.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cryopreservation Treatment
Human-derived cell samples undergo controlled freeze-thaw cycles using standard and enhanced cryopreservation protocols
Post-Thaw Evaluation
Post-thaw evaluations include viability assays, growth kinetics, apoptotic markers, metabolic profiling, and structural assessment
Follow-up
Long-term viability and functional recovery assessments are conducted
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?
3
Treatment groups
Experimental Treatment
Placebo Group
Human-derived cell samples are processed using a conventional laboratory cryopreservation protocol to establish baseline post-thaw viability and cellular recovery metrics.
Human-derived cell samples are processed using an optimized cryopreservation protocol designed to reduce cryo-induced cellular injury and improve post-thaw functional recovery.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Truway Health, Inc.
Lead Sponsor
Citations
Enhancement of Cell Recovery for Dissociated Human ...
Our results showed that around 80% of cells were alive immediately after thawing for both culture systems at all tested conditions except for 10% PROH.
Reassessing Long-Term Cryopreservation Strategies for ...
At the cell culture initiation, the 3 vials randomly selected from the EOPCB showed comparable recovery rates of around 98% upon thawing (Figure 1b).
Impact of Cryopreservation and Freeze-Thawing on ...
We review the current state of the literature on how cryopreservation of cellular therapies has evolved and how the application of this technique to different ...
4.
ctv.veeva.com
ctv.veeva.com/study/evaluation-of-in-vitro-cryo-therapeutic-protocols-on-human-cell-samples-twh-cryo001Evaluation of In-Vitro Cryo Therapeutic Protocols on Human ...
This laboratory-based study evaluates the effects of controlled cryogenic preservation on human cell samples using Truway Health's in-vitro ...
Improving Cell Recovery: Freezing and Thawing ...
However, it has been described that adding 30% KSR to the freezing medium can improve cell recovery after thawing. The Allen Institute for Cell Science, USA, ...
Cryopreservation-induced delayed injury and cell-type- ...
HUVEC and PCEC monolayers exhibited no significant immediate post-thaw injuries nor delayed injury responses during the 24-h post-thaw overnight culture period.
Optimizing cryopreservation strategies for scalable cell therapies
This comprehensive review examines the latest advancements in cryopreservation techniques across various cell therapy platforms.
(PDF) Impact of Cryopreservation and Freeze-Thawing on ...
Recent Findings: We review the current state of the literature on how cryopreservation of cellular therapies has evolved and how the application ...
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