Description

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. In adult, stem cells could be found in various specialized tissues including; the brain, bone marrow, umbilical cord blood, liver, synovium, Wharton’s jelly, fat tissues and even dental pulp. Because of their accessibility and simple isolation, the usual sources of stem cells for laboratory operations are fat tissue, bone marrow and Wharton’s jelly 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. It seems to contribute to long-term regeneration. Also they capable of alleviating or even curing some disease due to;

StemSin™

1-Secretion of immunomodulator, inflammatory factors and growth factors

2-Ability to migration to damaged tissue

3-Ability to differentiation to adult cells

4-Evading the immune system and suppressing the immune response

5- Stimulating endogenous healthy cells in damaged tissue

Production process

At the first, a sample of tissue (that contains stem cells) are taken by physician in sterile condition and then transferred to SinaCell laboratory. After cell extraction and expansion in laboratory, the product is ready to injection to patients. It may takes time about 45-60 days after sampling according the amount of cells that need for treatment. Patients can use their own cells that proliferate in laboratories (autologous form) and because MSCs, can evade immune systems, they also can benefit from others human stem cells (allogenic forms).

Dosage forms and administrations

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).

Contraindications

1-Having HIV, HBV, HCV, HTLV1 and endemic viruses

2- Having active bacterial or fungal infections

3-Those who have tumors or malignant disease

Caution

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 markers using flow cytometry device.

-Investigating of viral contaminations (HIV, HBV, HCV and HTLV)

-Potential for differentiation to osteocyte and adipocyte cells.

Adverse reactions

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

Warnings     

Avoid to use if cell container (50 ml vial) broken or damaged.