FDA approves TCA-CT's adult stem cell protocol for conducting Phase I clinical trials in ALS

Jan 18 2010

TCA Cellular Therapy, LLC (TCA-CT) announced today that the U.S. Food and Drug Administration (FDA) has approved its adult stem cell protocol to conduct Phase I clinical trials to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease).

“I hope that our trial, along with the combined efforts of scientists and patients, will pave the way to breaking the chains of this devastating disease”

This is the second FDA-approved protocol for the treatment of ALS using stem cells in the country; and the first using adult stem cells from the same patient. The aim of the Phase I study will assess safety.

ALS afflicts approximately 30,000 Americans. More people die of ALS than Huntington’s disease; and the fatalities nearly equal Multiple Sclerosis. The life expectancy of a patient diagnosed with ALS is two to five years.

“I hope that our trial, along with the combined efforts of scientists and patients, will pave the way to breaking the chains of this devastating disease,” stated Gabriel Lasala, M.D., president and CEO of TCA Cellular Therapy.

SOURCE TCA Cellular Therapy