Approved: 1st human trial with embryonic stem cells

Jan. 23, 2009 -- Geron Corp. will test its OPC1 cells in 10 patients completely paralyzed by recent spinal cord injuries. It's the first FDA-approved study of an embryonic stem cell product in human patients.

Patients enrolled in the study will have suffered very severe spinal cord injuries that have completely cut off nerve signals from the spine to the brain. A major factor in such injuries is loss of the myelin sheath that protects nerve cells. It's hoped that the OPC1 cells will restore nerve function not only by replacing lost myelin but by giving off chemical signals that promote new nerve growth.

I suppose I should be outraged, but I am not, just weary.  I knew this day would finally come.  Of course the source of the stem cells for this trial is morally repugnant, but it is a small consolation that these were cells from the embryonic stem cell lines approved for federal funding.  This means that they were ripped from a human embryo before 2001 and no new embryos were destroyed to make this trial possible.  A very small consolation indeed.

My greatest concern today, honestly, is the safety of the ten patients enrolled in the study.  The problem of tumors is still fresh in my mind and I fear for them.  Researchers are also concerned about safety:

The initial 10-patient study will use small doses to make sure the treatment is safe. Only if safety is ensured will the trial be expanded to use therapeutic doses of the cells. However, even this first study will gather data to see if there's any sign of improvement.

I also hope these patients' spirits are not broken if all fails which according to some is a distinct possibility:

Cell biologist Robert McKeon, PhD, studies spinal cord injuries at his Emory University lab. He's familiar with the Geron cells.

"They are asking these cells to do something I don't know they are capable of doing," McKeon tells WebMD. "The hype we often hear is that these cells will reconstitute the spinal cord and provide new tissues to promote recovery. When you ask oligodendrocytes to grow nerve cells, to make synapses, and to modulate the inflammatory damage from the injury -- that is a lot to ask an oligodendrocyte to do."

Okarma notes that the OPC1 cells have restored nerve functions in animal studies. But McKeon says actual human spine injuries are much more complicated than those studied in lab animals.

I pray these ten people walk again.  I just wish fellow human organisms did not have to be pulled apart to be part of the treatment.  A treatment that maybe worse than the injury.  I truly feel these patients need our prayers.  Especially since similar patients in Scotland could be treated with adult stem cells:

Patients paralysed by spinal injuries in Scotland could be given stem cell transplants to help them move and feel.

David Allan, director of the Queen Elizabeth National Spinal Injuries Unit in Glasgow, said Scotland was being considered as a trial centre for the cutting-edge treatment which it is hoped could reduce nerve damage.

Scientists in Scotland are already looking at taking tissue from the nose and implanting it where the spinal cord is broken to help nerve cells to regrow.
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Patients undergoing very common operations for nasal blockages, such as polyp removals, are being asked if tissue taken during surgery which would normally be thrown away can be used to explore this potential.

The laboratory experiments will help confirm if cells could be taken from the noses of people shortly after they have broken their spinal cord and then implanted to help reduce their level of disability.