Stem Cell

Although new and in the experimental stages the results of stem cell research is promising and will certainly impact the health care environment in the future.

Currently, some medical devices companies developing stem cell technologies are so optimistic that once clinically proven it will enable the therapy of heart failure, treatment of blood disorders, cardiovascular disease, cancer; skin cells for dermatological conditions; neuronal cells for spinal cord injury; and liver cells for hepatitis and cirrhosis

The body’s specialized cells cannot reproduce by natural processes if seriously damaged or diseased. Stem cell technology can be used to generate healthy and functioning specialized cells, which can then replace diseased or dysfunctional cells.

Replacing diseased cells with healthy cells, called cell therapy, is similar to the process of organ transplantation. Some conditions or injuries can be treated through the transplantation of entire healthy organs.

Currently available are, The Guidelines for the Clinical Translation of Stem Cells which highlights the scientific, clinical, regulatory, ethical, and social issues that should be addressed so that basic stem cell research is responsibly translated into appropriate clinical applications for treating patients.

The Guidelines address three areas of stem cell research:

(a) cell processing and manufacture(b) preclinical studies (c) clinical research

Contact Medical Devices & Biosciences International for your next medical device premarket application.