Special properties that only MSC possess (i.e. other stem cells do not)
Mechanism #1: Secretome consisting of healing and anti-inflammation factors into blood that circulate throughout the entire body, exerting anti-aging effects directly on your cells and indirectly by stimulating your own stem cells everywhere in your body.
Mechanism #2:MSC homing to damaged organs and replace damaged cells by differentiating into type of cell required for replacement.
Mechanism #3:MSC physically interacts with major immune cells from both innate and adaptive immune system (T cells, monocytes, NK etc.) to reduce their activation status. MSC also achieves this through secretome containing anti-inflammation factors that act directly on immune cells.
#1 – MSCs can be obtained by puncturing the bone and sucking out the bone marrow, which contains some MSCs. But the procedure can be painful and quantity is quite limited.
#2 – MSCs can also be obtained by liposuction from fat tissues. Although large quantities of fats are extracted, only a small fraction contains MSCs. Liposuction is a surgery that requires anesthesia (relatively risky and requires post-surgery recovery time).
While using MSCs extracted from your own body is an attractive idea, the extraction procedures can create discomfort and inconvenience. Moreover, MSCs derived from either bone marrow or fat tissues require donors to be very young age for their cells to have sufficient potency. Using your own MSCs as an adult especially above a certain age may not lead to benefits.
#3 – Umbilical cord is a rich source of MSCs and generated as a medical waste and can be ethically obtained. Umbilical cord samples is obtained without any risk or pain to both the mother and baby.
MSCs obtained from umbilical cord is also the youngest (Age 0) and hence the most potent. MSCs obtained from adult bone marrow and fat tissue are older and hence less potent.
Source traceability means having documentation to show the origin of the material and evidence that they are free of infectious diseases and ethically obtained. For example, donor’s biological information such as age, medical history, inherited (genetic) disease, infectious disease (e.g. HIV/ Hepatitis/ Syphilllis etc), written consent. These are non-identifiable information and does not violate Singapore privacy law (PDPA).
In Stemigen’s collaboration project with KK Hospital to obtain umbilical cord for research purposes, the required tests and written consent are done independently at KK Hospital. This ensures that critical step of source traceability is established independently so that the required screening test and quality checks could not be faked.
From medical standpoint, autologous cell therapy is the safest approach because you are using cells extracted from your own body. As autologous cells are identical with your blood type, there will never be any immune rejection, a side effect that can be sometimes lethal. This is true for most cell types except MSC.
But MSC is one of the rare cell type that does not require blood type match because it express negligible levels of blood type marker. Therefore, a person can receive MSC donated by another person without any immune rejection. Even with a very small risk, more than a decade of clinical trial done in the field of MSC therapy has found no adverse reactions in patients who received MSC from other people (allogenic).
Therefore it can be concluded that allogenic application of MSC is as safe as autologous application.
(P/S: This is not true for all other cell therapies)
“Xeno free” and “free from animal components” have the same meaning. It means the reagent is not derived from animal sources. “Serum free” means that the reagent does not contain serum derived from humans or animals
Serum and enzymes used by MSC manufacturers are often derived from animals. Animal derived serum and enzymes are used because they are significantly cheaper than those of human origin, and it is not easy to detect in the final product. Unknown pathogens (especially viruses) present in serum are easily transmitted into MSCs and spread to recipient during infusion. Also, animal components (in serum or other reagents) can stimulate undesirable immune responses as the human body is not compatible with animal components.
All reagents used by Stemigen is 100% free from animal components (xeno free), serum free and of the highest quality (i.e. GMP grade with valid certificate of analysis). Always insist on verifying reagent quality with the valid certificate of analysis.
At Stemigen, our QC tests comply with requirements by local and global standards. QC tests are also carried out with scientific rigor (i.e. duplicates, error analysis etc).
First test category is regarding the accurate confirmation of MSC identity. These QC tests are required by International Society for Cell and Gene Therapy (ISCT).
Second test category is regarding the sterility of the cell sample. These QC tests are required by Health Sciences Authority (Ministry of Health, Singapore).
At Stemigen, we do not cut corners on QC and scientific due diligence to reduce cost of goods.
Frozen stem cell vials are stored in a vacuum-insulated stainless steel tank filled with the recommended amount of liquid nitrogen for deep cryogenic storage (-196oC). All cryostored samples are monitored daily to ensure that stable temperature is maintained and backup system is functional.
Our equipment undergo maintenance (calibration/certification) every year. For critical equipment such as the Biological Safety Cabinet, certification is done every 6 months.
3D technology provide stem cells 3D surfaces to grow on. It closely mimics natural microenvironment found in living tissues. Interactions of stem cells with the 3D microenvironment promotes greater cell growth, proliferation, and potency.
NK cells are special because they are able to destroy all types of cancer cells and infected cells without prior need to identify the type of tumor or pathogen. This is due to their unique mechanism of action, which is described in another FAQ.
Under normal circumstances, NK cells forms 5 – 15% of white blood cell population in our blood. They are derived from whole blood. A careful isolation procedure is needed to extract NK cells from whole blood. NK cells can also be derived from cord blood (if available)
NK cells kill cells they do not recognize with 2 different mechanisms: Apoptosis (cell shrink until it implodes into smaller pieces) and Necrosis (cell bursting out all internal contents).
NK Cells use cell surface markers to initiate recognition. Healthy cells contain markers to inhibit NK cell killing. Infected/cancer cells do not have those markers to stop NK cell killing. Some may even contain markers that trigger NK cell killing. NK cells are also able to alert other immune cells, e.g. T cells and antigen presenting cells (APC), to the presence of “invaders”.
NK cells form 5 – 15% of white blood cell population inside our blood. The white blood cell population contain many other types of immune cells such as lymphocytes, monocytes, basophils, neutrophils, eosinophils etc. These non-NK cells (85 – 95%) should be excluded to ensure NK cell purity and complications during cell expansion.
NK cell purity is determined by flow cytometry, which is a very reliable scientific method of analysis. During flow cytometry, NK cells are identified using very specific markers found only on NK cell, and they are physically counted one by one until the whole sample is fully analyzed.
NK cells form 5 – 15% of white blood cell population in our blood. By centrifugation, especially in a density gradient, white blood cells can be effectively separated from red blood cells. Thereafter NK cells cannot be further isolated from other white blood cells such as T and B lymphocytes, significantly compromising NK cell purity.
On the other hand, Stemigen’s proprietary separation technology can extract NK cells with >99% purity from whole blood.
Exosome are special because of 2 main features: (1) Its nanometer size is easily absorbed by tissues and cells. (2) It contains biomolecules capable of activating metabolic bioprocesses within the cells.
Exosomes are functional vehicles (for intercellular communication) that carry a complex cargo of proteins, lipids and nucleic acids that are taken up by cells they encounter. Once inside the cell, the exosomes exert an effect in the cell by altering cellular, metabolic and immunological processes.
Exosomes are nanometers in size and they cannot be seen using our eyes even through normal microscopes. Therefore particle analysis is required for their detection. Physical method also determines the exosome sizes, which must be within the range acceptable for cell absorption.
Nanoparticles detected by physical method is insufficient to confirm the presence of exosomes because the supernatant contains a variety of other nanosize materials such as proteins, metabolic wastes and cell debris. Therefore chemical method must also be performed to detect surface markers specific to exosomes to authenticate the nanoparticles detected by physical method of analysis.