This past week, news came out that Geron would continue with its embryonic stem cell treatment in the U.S. for spinal cord injuries.  Now, TCA Cellular Therapy has released news that they also will be beginning a human clinical trial in the United States for the treatment of spinal cord injury.

This treatment will be using adult stem cells, which are derived from the trials participants.  The trial’s first participant is paralyzed war veteran, Matt Cole.  In 2005, while serving in Iraq, this Marine was paralyzed from the chest down after suffering injuries from an insurgent attack.

The procedure is proprietary to TCA Cellular Therapy, and involves using the bone marrow of the recipient.  Marrow from the bones contains many different types of stem cells that can produce functional cells.

Already, a few thousand adult stem cells have been removed from Cole’s bone marrow.  Mensenchymal stem cells have been separated, purified, and multiplied.  The stem cells will be infused into Cole’s damaged spinal cord.  It’s hoped that these adult stem cells will produce functional cells that will aid in the healing process of damaged neurological tissue.

Safety will be the first issue, so Phase 1 will be used to assess the safety of intrathecal infusion of autologous Mensenchymal stem cell treatment in spinal cord injury.

The trial will start in August of 2010.  Final data collection for this first phase is expected to be completed by March of 2012; with a study completion date in June of 2012.

Candidates are being sought for this groundbreaking human clinical trial.  Follow the link below to read more about eligibility of this adult stem cell treatment for spinal cord injury.

Clinical trial eligibility requirements.

This study is different than the Geron embryonic stem cell trial, as the TCA Cellular Therapy trial involves adult stem cells, and those people injured within the last five years.  The Geron trial will only be using those with acute spinal cord injuries.

His trial is significant because it marks a move from the lab, and tests on mice, to human clinical trials in the United States for spinal cord injury.

Yes!  Geron has received the green light from the FDA to begin the Phase I clinical trials of GRNOPC1 in people with acute (this means people newly injured, and probably in ICU) spinal cord injuries.

This signifies the first time a human embryonic stem cell (hESC)-based therapy will be used on humans (in the United States).  Currently other countries such as China and European nations are proceeding with embryonic stem cell therapies, but the documentation on the procedures used and success rates are sketchy.

With FDA approval to proceed in the United States, it will mean that Geron will follow strict guidelines every step of the way.  In Phase 1, patients with “complete” injuries will receive the GRNOPC1 therapy.  Paraplegics with injuries from the T3 to T10 spinal column will be injected (with their consent) between seven and 14 days after injury to the spinal cord.

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged — to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer’s, multiple sclerosis and Canavan disease.”

Safety of the therapy will be assessed as well as the awaited results of improved changes in movement and sensation in the lower extremities and legs.

With the success of this first phase, Geron will extend the study. Newly injured patients with complete cervical injuries, and then patients with severe incomplete (ASIA Impairment Scale grade B or C) injuries, will undergo the therapy.  Each phase must meet FDA approval.

U.S. Medical test sites (up to seven) conducting the therapy, will be announced as patients (unlucky but possibly very lucky)  are enrolled in the study.

Good luck Geron!