Our lab uses isolated and expanded autologous or allogenic stem cells under the International Society for Cellular Therapy (ISCT) standards.
Cell production is currently being expanded from the Wharton’s Jelly derived from umbilical cord of authorized and certified donors. These are certified Mesenchymal Stem Cells (MSC’s) produced with rigorous laboratory standards for processing and manipulation of stem cells; we guarantee the rights of the donor, the quality of the sample and the adherence of good practices for cellular manufacturing practices.
These ISCT standards apply both to research and to application in related exception cases such as:
"Hospital exception" clause authorizes hospitals and doctors the use of these cellular therapies with no previous commercialization but with good therapeutic evidence under the exclusive doctor’s responsibility.
"Compassionate use" in which the patient with a disease that could put his life in danger, chronic or weakening, and it is not able to be controlled by authorized drugs could be able to access a therapeutic resource under research, outside of the clinical trial.
We comply with quality requirements such as:
- STANDARDS OF THE ISO 14644
- COMPLIANCE OF THE INFORM 46 FROM THE GLOBAL HEALTH ORGANIZATION
- COMPLIANCE WITH ISCT (INTERNATIONAL SOCIETY FOR CELLULAR THERAPY) STANDARDS