Stem cells are considered one of the most promising resources in modern medicine. Whether hematopoietic stem cells from bone marrow, mesenchymal stem cells from adipose tissue or induced pluripotent stem cells (iPSCs) from the laboratory - their potential to regenerate damaged tissue and cure serious diseases is enormous. The number of clinical studies based on stem cell-based therapies is growing exponentially worldwide.
However, this potential is linked to one crucial condition: The cells must be available at the right time and in the highest quality. In practice, this means that weeks, months or even years can often pass between the collection of a stem cell sample and its therapeutic application. During this period, cryopreservation takes on the critical task of stopping the biological clock.
Consarctic® understands this responsibility like no other cryotechnology company in Germany. In this article, we shed light on the challenges stem cell banking poses for cryotechnology and why choosing the right equipment can determine the success of the therapy.
Not all cells react in the same way to the freezing process. Stem cells are among the most sensitive cell types of all. Their high metabolic activity and ability to differentiate make them susceptible to the physical stresses that occur during freezing.
During freezing, ice crystals initially form in the extracellular space. This increases the salt concentration outside the cell, which leads to an osmotic imbalance. Water flows out of the cell, it dehydrates and shrinks. If this happens too quickly or in an uncontrolled manner, the cell membranes can be irreparably damaged.
If the cooling rate is set too high, the intracellular water does not have enough time to leave the cell. It freezes directly inside the cell and forms sharp-edged ice crystals that mechanically destroy organelles and membranes. This phenomenon is the most common reason for the loss of cell vitality after thawing.
Latent heat is released at the phase transition point. This causes a brief but potentially fatal rise in temperature in the sample. This is where the TC-Active function of the Consarctic® BIOFREEZE® devices comes in: It automatically detects this moment and triggers shock freezing to immediately compensate for the released heat.
Controlled rate freezing is the scientifically recognized gold standard for the cryopreservation of stem cells. Unlike uncontrolled freezing in a freezer, a freezer such as the BIOFREEZE® BV45 or the SMARTLINE allows the cooling rate to be precisely controlled - typically at -1°C per minute.
The software of the BIOFREEZE® series allows researchers to create individual freezing curves that are adapted to the specific cell type. A different curve is optimized for hematopoietic stem cells than for mesenchymal stem cells or iPSCs. This flexibility is essential in a GMP-compliant environment.
A decisive advantage of the controlled rate freezer is the complete reproducibility of every freezing process. Each curve is digitally logged and can be archived as part of the batch documentation. This transparency is essential for clinical applications where regulatory authorities require evidence.
Cryopreservation does not end with freezing. A stem cell sample typically passes through several stages on its way to the patient:
An error at any of these stations can jeopardize the entire therapy. A rise in temperature during transfer, a leaking transport container or a power failure in the storage room - the risks are manifold. Consarctic® offers a customized solution for each of these stations, from initial consultation to 24/7 emergency service.
An increasingly important issue in stem cell banking is the question of the storage method: liquid phase or gas phase? In liquid phase storage, the samples are directly immersed in liquid nitrogen. This offers the lowest and most stable temperature, but carries the risk of cross-contamination between the samples via the liquid nitrogen.
Vapor-phase storage positions the samples above the liquid level. The temperature is still around -190°C, which is more than sufficient for safe long-term storage. The risk of cross-contamination is almost completely eliminated.
The Consarctic® steel tanks of the BSD+ and BSF+ series are specially optimized for gas phase storage. The eccentric opening and high vacuum insulation minimize nitrogen consumption while ensuring a homogeneous temperature profile throughout the storage space.
Stem cell products intended for clinical applications are subject to strict regulatory requirements. In Europe, the ATMP Regulation (Advanced Therapy Medicinal Products) governs the handling of such products. This has a direct impact on cryotechnology.
Consarctic® not only supplies the hardware, but also the associated documentation and validation services. Our certified technicians carry out the IQ/OQ and ensure that your system meets all regulatory requirements.
Stem cell therapy is on the cusp of a revolution. But every revolution needs a solid technical foundation. Cryotechnology from Consarctic® ensures that the most valuable resources in regenerative medicine - stem cells - are available at any time, in any place and in the highest quality.
Are you planning to set up a stem cell bank or would you like to modernize your existing infrastructure? Our experts will be happy to advise you on the best solutions for your specific requirements - from individual samples to turnkey cryobanks.