News

Paralyzed Bay Area patient gets stem-cell therapy

Treatment tests safety of injecting stem cells in humans, with eye toward restoring feeling and mobility in paralyzed patients

The first paralyzed patient in the western United States to get an injection of embryonic stem cells underwent treatment at Santa Clara Valley Medical Center Saturday (Sept. 17), according to a statement by Stanford University School of Medicine.

Stanford School of Medicine and Santa Clara Valley are working together on the research, which could potentially restore functions to people with stroke, brain injury, Parkinson's disease and other devastating neurological disorders.

The medical centers have enrolled the fourth participant in the nation's first trial of stem cells derived from human embryos. The FDA-approved trial is meant to test the safety of injecting the cells in up to 10 people with recent spinal-cord injuries at seven trial sites across the United States. The trial is not intended to treat the patient's paralysis.

The patient was transferred from Kaiser Permanente and was treated at the Rehabilitation Trauma Center at Santa Clara Valley with cells prepared for injection at Stanford.

Stanford neurosurgeon Gary Steinberg, M.D., implanted the cells. Three other patients have previously received the surgically delivered cells: two at the Shepherd Center in Atlanta beginning in October 2010, and one at Northwestern Memorial Hospital and the Rehabilitation Institute of Chicago in May 2011.

The Stanford/Santa Clara Valley patient is the first person to receive the therapy west of the Mississippi, Stanford researchers said.

"We are extremely excited to participate in this landmark clinical trial," said Steinberg, the principal investigator of the Stanford/Santa Clara Valley portion of the trial.

"It signifies a major advance in translating an innovative research discovery into clinical therapy. I believe it is critically important to encourage and take part in stem-cell trials like this, which represent a new era in the effort to restore function for patients with ... devastating neurologic disorders," he said.

Stephen McKenna, M.D., chief of the rehabilitation center at Santa Clara Valley, agreed.

"Although it's been an intensive commitment of resources, we understand the importance of advancing new therapies for patients," he said.

The trial is being run by Geron Corp. of Menlo Park, which developed and manufactures the cells being tested. In May, Geron received a $25 million grant from the California Institute for Regenerative Medicine to continue and extend the trial to include a greater proportion of spinal-cord injured patients.

"When the people of California voted in favor of Proposition 71, they did so with the hope of seeing stem-cell-based therapies for chronic disease and injuries. This first California patient to participate in Geron's landmark spinal cord injury trial is a major step toward fulfilling that hope," said Jonathan Thomas, chair of the California Institute of Regenerative Medicine governing board.

"We are proud to be providing funding for this first safety trial, which is a critical step toward making safe and effective stem-cell-based therapies available to patients."

Researchers at Geron collaborated with Hans Keirstead and his laboratory team at UC-Irvine to develop a way to coax human embryonic stem cells to become a mixture of cells that include oligodendrocyte precursors.

Oligodendrocytes are cells in the brain and the central nervous system that wrap nerve cells with an insulating material called myelin. This myelin sheath is necessary for the transmission of the electric signals along the spinal cord that trigger muscles to move, and relay the sense of touch and temperature.

Damage to this sheath caused by trauma is a common cause of paralysis, according to researchers.

Patients in the trial were injured in the 14 days prior to participating in the trial in a specific region of their thoracic spine -- an area roughly from the top of the shoulder blades to the bottom of the rib cage. The damage caused complete paraplegia, meaning that they have normal sensation or movement to the level of the hands, but not from the trunk to the toes.

During the procedure, Steinberg applied about 2 million of the special cells directly into the injured area of the patient's spinal cord.

"The patient is doing well," he said.

Following the surgery the patient entered an intensive inpatient rehabilitation program. Researchers will now monitor the patient for any adverse effects to confirm that the cells are safe for use in humans.

In June, Geron reported preliminary trial results on the first two patients at two meetings -- the 2011 International Conference on Spinal Cord Medicine and Rehabilitation and the 2011 Spine Symposium.

The results so far show no significant adverse effects experienced by either patient. If this phase-1 trial of 10 patients shows that the treatment is safe, future trials will be designed to determine whether the cells are able to improve participants' clinical symptoms, researchers said.

Comments

Posted by Nayeli, a resident of Midtown
on Sep 20, 2011 at 12:09 pm

Our thoughts and prayers are with this patient!


Posted by Bob, a resident of Community Center
on Sep 20, 2011 at 12:44 pm

The Northwestern U. Hospital patient who got this treatment in May is the son of a high school classmate whose mother lives in the Oakland HIlls. Dad passed away two years go. Son is a medical miracle, now back to work, and now gets outpatient treatment at Stanford for foot pain .At the time, Stanford could not yet offer this. Before the NW treatment he was a 100% invalid.


Posted by wow!, a resident of Another Palo Alto neighborhood
on Sep 20, 2011 at 6:17 pm

Bob,
Can you please describe this in more detail? Are you saying a newly paralyzed patient with spinal cord injury who would otherwise not have recovered was given this procedure and is now walking and functioning normally? Please tell us more!


Posted by Bob, a resident of Community Center
on Sep 20, 2011 at 8:08 pm

To wow:

I'll try to find his mother's recent letter Will get back to you - maybe print the letter with ID removed. I know it was very serious. It did not, as far as I know, originate from a spinal cord injury. She said is was adult-onset multiple sclerosis. But except for his painful feet now, he is back working and flying his own plane. He recently came to Stanford for treatment of the painful feet.


Posted by Mark b, a resident of another community
on Sep 20, 2011 at 10:04 pm

Best wishes for this patient.....thoughts are with him from tons of people!


Posted by More info?, a resident of Crescent Park
on Sep 21, 2011 at 11:11 am

Bob, please do tell us more. The trial is for people with recent spinal cord injuries, so it's puzzling your classmate's son would have been part of the trial.


Posted by Paul, a resident of another community
on Sep 21, 2011 at 12:35 pm

Bob,
According to the GRNOPC1 clinical trial inclusion criteria are:

•Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels

A spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease.

I would find it surprising because it doesn't appear that someone with adult-onset multiple sclerosis is within the scope of the GRNOPC1 clinical trial inclusion criteria.


Posted by TEISSEDRE, a resident of another community
on Sep 21, 2011 at 1:42 pm

Merci a GERON pour avoir permis ce premier essais clinique.

Bonne Change au 4th patient

Meilleurs voeux de rétablissemnt.

AT


Posted by Bob, a resident of Community Center
on Sep 21, 2011 at 4:35 pm

To: Wow, More Info, and Paul,

Here is the info I have although I knew about it for over 18 months that the friend's son was very ill. (Sent to me September 12, 2011)

"He had a rare very aggressive form of MS which transformed him from a vital healthy man into a complete invalid unable even to feed himself, was losing his eyesight, and ability to breathe. Got sick just 6 months after his dad died. Stanford, UCSF, and Mayo had nothing for him. Found an experimental treatment at Northwestern in Chicago that involved transplanting the immune system which was attacking him with a completely new immune system using stem cells. Lots of chemo to kill off the old immune system then infused him with his own stem cells to grow new ones. Now he has a completely new baby immune system and the disease is complete gone, he's recovered all function, but the sensory nerves in his feet are still screwed up - probably permanently and cause excruciating pain. But he can walk tho not far, drive, and even flies his plane.........This treatment is a miracle. They have cured over 400 MS patients, and the big med centers don't know about it. Northwestern is the only place in the US that's doing it. There's one in Canada & Brazil (or Chile, I can't remember.)

Bob's note: this is all I know about this right now.


Posted by David Granovsky, a resident of another community
on Sep 21, 2011 at 7:15 pm

Let's not waste your time, I'll give you the results right now:

EMBRYONIC STEM CELL (ESC) breakdown:

SOURCE/DERIVED FROM: comes from embryos
PURPOSE IN BODY: split for 7 weeks until you have a fetus the size of a thumbnail
OBSTACLES+SIDE EFFECTS: they create cysts and tumors, rejection requires immunosuppressive drugs for the ill patient, they carry the genetic anomalies of the donor, etc
TREATMENT HISTORY: can currently treat zero diseases, probably need to cure cancer first to use them
via Web Link

Why? Because... Web Link

If you are looking for positive stem cell treatments for spinal cord injury, here's 60+ articles... Web Link


Posted by Chris, a resident of Old Palo Alto
on Sep 22, 2011 at 8:56 am

Iam saying prayers for this patient and the heroic journey they have begun


Posted by Sickened, a resident of Greater Miranda
on Sep 22, 2011 at 10:21 am

Frankly, this sickens me.

How old must a person be before they can NOT be harvested for use by another?


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