Views: 0 Author: Site Editor Publish Time: 2025-05-30 Origin: Site
Stem cell therapy has shown great potential in the fields of regenerative medicine, immunotherapy, and disease model construction. However, its clinical application transformation faces many challenges, and one of the key links is the cryopreservation and thawing of stem cells. The performance of cryopreservation solutions directly affects the survival rate, functional stability, and treatment safety of stem cells. Therefore, it is crucial to select a cryopreservation solution that is serum - free, DMSO - free, supports high - density cryopreservation, and has a high thawing survival rate.
1. What are the core requirements for clinical - grade cryopreservation solutions?
When stem cell therapy enters the clinical stage, it must meet strict quality standards. The selection of cryopreservation solutions needs to meet the following core requirements:
(1) High safety
① Well - defined components, in line with GMP standards
Select a chemically - defined formula and avoid animal - derived components; ensure that production complies with GMP regulations and has complete quality control documents.
② Serum - free
Traditional cryopreservation solutions often rely on fetal bovine serum, but serum has the following problems:
Large batch - to - batch variability, affecting cryopreservation stability.
Risk of potential pathogens (such as viral and mycoplasma contamination).
Risk of immunogenicity, which may cause adverse reactions in recipients.
Therefore, clinical - grade cryopreservation solutions should completely avoid serum components and adopt a formula with well - defined chemical components.
③ DMSO - free
Dimethyl sulfoxide (DMSO) is the main cryoprotectant in traditional cryopreservation solutions, but it has obvious drawbacks:
Cytotoxicity: High concentrations (usually 10%) may damage cell membranes and organelles.
Adverse reactions in patients: After infusion, it may cause nausea, allergies, and even cardiovascular events.
Regulatory restrictions: Some countries (such as Japan) have restricted the clinical application of DMSO.
Therefore, clinical - grade cryopreservation solutions should choose a cryoprotectant that is at least as effective as DMSO but safer. It should not only have excellent cryopreservation effects but also be safe enough.
(2) High cryopreservation performance: High - density cryopreservation and high thawing survival rate
High - density cryopreservation: Clinical - grade stem cells usually require high - density cryopreservation. The cryopreservation solution needs to maintain cell viability at a low volume. It is necessary to consider saving storage space and the amount of cryopreservation solution used, as well as whether the number of cells in each cryotube is convenient for clinical use to avoid multiple freeze - thaw cycles.
High thawing survival rate: After thawing, cells should maintain their original proliferation, differentiation, and therapeutic functions.
Long - term stability: It can still maintain efficient thawing after long - term storage in liquid nitrogen.
2. What scenarios are different types of cryopreservation solutions suitable for?
| Type of Cryopreservation Solution | Core Advantages | Optimal Application Scenarios |
| Traditional serum - containing cryopreservation solution | Low cost, simple preparation | Basic laboratory research |
| Serum - free cryopreservation solution | Well - defined components, safe and standardized | Pre - clinical research / early - stage clinical trials |
| GMP - grade vitrification cell cryopreservation solution | Free from DMSO toxicity, high safety, supports high - density cryopreservation | Comprehensive clinical applications |
2. What are the advantages of Yocon's GMP - grade vitrification cell cryopreservation solution compared with traditional cryopreservation solutions?
Compared with the performance of traditional cryopreservation solutions, Yocon's GMP - grade vitrification cell cryopreservation solution has the following advantages:
| Performance Indicator | GMP - grade Vitrification Cell Cryopreservation Solution | Traditional Cryopreservation Solution |
| Main Components | All components are well - defined, serum - free, protein - free, DMSO - free | Usually contains serum, complex components |
| DMSO Concentration | DMSO - free | Usually high (10%), highly toxic |
| Cell Viability | >95% | 70 - 85% |
| Function Maintenance | The differentiation, paracrine, and immunomodulatory functions of MSCs are intact | The functions of MSCs may be partially impaired |
| Clinical Application | Can be used directly after thawing | Often requires washing to remove DMSO |
| Safety | Non - toxic, no risk of adverse reactions | DMSO may cause adverse reactions |
| Convenience | No programmed cooling is required. It can be directly placed at - 80°C and then directly placed in liquid nitrogen for long - term cryopreservation after 12 hours. | Requires programmed cooling |
| Transportation and Storage | Protein - free, can be transported and stored at room temperature | Requires low - temperature storage |
3. What is the cryopreservation and thawing effect of Yocon's GMP - grade vitrification cell cryopreservation solution?
(1)Cell thawing status
 |  |
| P5 | P6 |
Cells thawed using GMP - grade vitrification cell cryopreservation solution, when passaged at 8000 cells/cm², can reach a confluence of 90% within 72 hours. The cells adhere well, have a uniform growth direction, and are plump in shape.
(2)Verification of thawing rate and viability
The cell thawing viability of Yocon's GMP - grade vitrification cell cryopreservation solution can be stably maintained at nearly 100%. The cell thawing rate is slightly higher than that of DMSO cryopreservation solution and much higher than that of imported finished cryopreservation solutions.
(3)Verification of apoptosis rate and viability
Among the four comparable products, Yocon's GMP - grade vitrification cell cryopreservation solution performs best in reducing cell apoptosis and maintaining cell viability, with the lowest apoptosis rate; the performance of DMSO, Brand P, and Brand Z is relatively close but slightly inferior to Yocon Biotech.
(4)Comparison of amplification multiples
When compared with DMSO cryopreservation solution and imported finished cryopreservation solutions, there is almost no difference in the cell thawing amplification multiple of Yocon's GMP - grade vitrification cell cryopreservation solution.
