Allo-StemsinTM is a human mesenchymal stem cell product. Mesenchymal Stem cells are undifferentiated cells that can self-renewed, differentiate to the different kinds of cells like cartilage cells, bone cells, fat cells, nerve cells and muscle cells and etc. Nowadays stem cell therapy has been used in many degenerative disease like: autoimmune (MS, ALS), cardiovascular disorders, neurological disorders (Alzheimer, Parkinson), bone and cartilage injuries and even cancers. Since these cells have the ability to evade the immune system can also be used as Allogenic forms. This features is important in old persons, because their cells have not good growth and in children due to difficult sampling. They capable of alleviating or even curing some disease due to;
1-Secretion of immunomodulator, inflammatory factors and growth factors
2-Ability to migration to damaged tissue
3-Ability to differentiation to functional cells
4-Evading the immune system and suppressing the immune response
5- Stimulating endogenous healthy cells in damaged tissue
In this cause, mesenchymal stem cells were isolated from Wharton’s jelly (taken from umbilical cord) by enzymatic method at SinaCell manufacturing site. After cell isolation, the cells were expanded during cell culture process in clean room facility and qualified by quality control methods. Approved cell were collected and packaged in suitable containers and send to the hospital.
Dosage forms and administrations
Allo-StemsinTM is an injectable cellular suspension. Physician should prescribe the dose and pattern of use. But usual prescription is;
-Peripheral injection:1- 2×106 in each Kg of patient’s body weight.
-Local injection: it depends on local site (for example: for intra techal injection, 20-40 ×106 cells are suitable).
1-Having HIV, HBV, HCV, HTLV1 and endemic viruses
2- Having active bacterial or fungal infections
3-Those who have tumors or malignant disease
Use with caution and medical supervision in the following cases:
- Patients using cytotoxic drugs
- People that injected hyaluronic gel in knee joint in the past month
- People that have an allergy to animal proteins
Quality control tests
For preparing the best product to use, we do variety of tests like:
-Examination of microbial and fungal contaminations (sterility test)
– Investigating of mycoplasma contaminations
– Investigating of endotoxin contaminations
-Investigating of mesenchymal stem cell surface marker using flow cytometry device.
-Investigating of viral contaminations (HIV, HBV, HCV and HTLV)
-Potential for differentiation to osteocyte and adipocyte cells.
Not serious reactions reported. Only some fever and headache may be occur in intra techal injection. There is the possibility of temporary increase in white blood cells and mild fever in systemic injection. Patients would be hospitalized for hours to a day after injection.
Product box contents
The product box containing:
- 50 ml vial of Allo-StemsinTM
- Ice bag
- Product leaflet
Storage and handling
This product should be injected as soon as possible (the injection time will be informed to patients by sinaCell experts). Allo-StemsinTM is stable 4 days at 2-8 ◦C.
Avoid to use if Cell container (50 ml vial) broken or damaged.