Stem-cell Therapy for Humans Approved

Clinical trials involving embryonic stem cells to treat spinal-cord injury have been approved by the US Food and Drug Administration (FDA).

This is the first time embryonic stem cells will be tested on humans.

Clinical Trials | Drug Trials - Types Protocol Development and Approval FAQs
Clinical trials are experiments that yield useful information to clinicians if a particular treatment is of any value to a patient.

Geron Corporation, which developed the treatment, said the FDA had removed a clinical hold on its GRNOPC1 therapy.

It hopes to start testing GRNOPC1 on humans by the end of this year, enrolling eight to 10 patients across the US.

The trial will last about two years, with each patient being studied for one year.

Clinical Trials and Its different Phases
Clinical trials serve as a vital component for improving the treatment of medical conditions as they lead to higher standards of patient care.

The FDA accepted Geron's January 2009 study application, but then placed any potential study on hold last August because some mice treated with GRNOPC1 developed spinal cysts, reports The Sydney Morning Herald.

However, Geron claims to have found a new way to test GRNOPC1 and said it did not see any cysts in a separate animal study.

About Stem Cells
Encyclopedia section of medindia gives general info about Stem Cells

A successful test would lead to larger and longer studies that would focus on the effectiveness of GRNOPC1.

The company says it will monitor patients for 15 years for safety.

Novel Method may Make Stem Cell Therapy Cheaper
A novel method to sort stem cells that could prove quicker, easier and more cost effect than existing methods.

Source-ANI