TODAY! Spinal Cord Injury Trials go Forward with Embryonic Stem Cells— as the Law Which Funded the Research Fights for Existence
By Don C. Reed
Today, July 30th, 2010, the biomedical company Geron announced the FDA go-ahead for the world’s first human trials with embryonic stem cells*.
The research behind this ground-breaking event was paid for a California law named after my paralyzed son, the Roman Reed Spinal Cord Injury Research Act of 1999.
As Geron CEO Dr. Thomas Okarma said in a letter supporting the renewal of Roman’s law:
“…Geron Corporation succeeded in achieving FDA concurrence to begin the World’s first human trial of our embryonic stem cell-based therapy for spinal cord injury. This would not have been possible without support from the Roman Reed Program…”
Monday, August 2, that law will fight for its existence: not for funding—the $1.5 million annual appropriation is apparently not affordable at this time—but just to stay alive, while we who support it hunt for alternative means of funding.
When my son Roman Reed broke his neck and became paralyzed from an accident while playing college football, September 10th, 1994, it was the worst day in our family’s life.
But something beautiful came from his pain, and his unconquerable spirit: a California law, the Roman Reed Spinal Cord Injury Research Act of 1999. That bill will be before the Appropriations Committee on Monday August 2, for renewal as AB 1931, championed by majority leader Alberto Torrico (D-Fremont).
For the past nine years, the program has not only brought progress in research for cure of paralysis, but has also been a revenue producer for our state. Roughly $14 million in California dollars has attracted an additional $60 million in matching grants and donations, a return of more than four to one on our investment.
Small in cost (its $1.5 million a year is the expense of caring for two paralyzed people for one year) but mighty, “Roman’s law” has taken real-world steps toward cure of the most devastating condition short of death itself. With 175 published papers, two patents pending, and research which may result in the world’s first clinical trials of a possible paralysis cure this coming fall, the program is a triumph: government at its best.
The renewal bill must go forward and California’s financial difficulties cannot jeopardize its progress.
We have seen it work.
On March 1, 2002, I held in my hands a laboratory rat which had been paralyzed, but which now walked again, thanks to research funded by the Roman Reed Act. Imagine what that felt like, to feel the tiny muscles moving, which had frozen into immobility before—and this while my son watched from his wheelchair.
The research was done by Dr. Hans Keirstead, one of the most promising scientists in the world. His courage and creativity are unmatched. We are deeply appreciative—and we are glad the Roman Reed Act existed, to provide that all-important first funding, a $92,000 grant, when nobody else would.
The entire program is overseen by Dr. Oswald Steward of the Reeve Irvine Research Institute at UC Irvine, himself a champion scientist, who advances the research.
Christopher “Superman” Reeve gave us his blessing, saying, “One day, Roman and I will stand up from our wheelchairs, and walk away from them forever.” Cure did not come in time for our paralyzed champion, but we still believe in that great dream. The flame of his faith still guides our path.
Imagine the nightmare of paralysis. In addition to the loss of control over your own body, you face staggering medical expenses, as much as “$775,567 in the first year
alone, with an additional $138,923 every year thereafter.” (Source: University of Alabama National Spinal Cord Injury Statistical Center, Centers for DiseaseControl and Prevention.) Caregiver costs are immense in financial, physical, and emotional terms.
Most families cannot absorb this colossal medical expense, and must turn to government assistance– which means the American taxpayer.
My son never complains. But I am his father, and I know what he goes through: the endless frustration, the physical pain, and the loss of mobility, taken from a champion athlete. But he won’t give up. It has been fifteen years and he is still just as determined as he was the first day of the accident, when we were riding in the emergency van, and he said: “Don’t worry, Dad. This is just get temporary. We’ll get out of this.”
His life has gone on, of course. He faces each day with courage and determination. He and wife Terri raise their three children, and Roman is Commissioner for Health and Recreation of our home town of Fremont.
But he still intends to walk down the beach with his children one day.
When that happens, when Roman Reed stands up from his wheelchair, he will take millions with him; cure must be for everyone.
In California alone, an estimated 646,000 citizens suffer paralysis; nationally, it is estimated that every 41 minutes another American incurs this devastating malady.
Through the UC system, the Roman Reed program funds research for cure, aimed at restoring function, and to bring more independence to a paralytic’s life.
In addition to 175 peer-reviewed scientific publications, the Roman Reed Act has funded scientists developing new ways to rehabilitate with cost-saving robotics; a helmet which uses brain waves to operate a computer; enhanced research tools like a Petri dish which can sort cells, replacing a multi-million dollar machine; and even finding ways to lessen the damage of the injury itself, by controlling the body’s trauma reaction.
The program has brought new money to California: leveraging our state’s ten year contribution of $14 million with an additional $60 million more in grants and donations from outside sources;
The research funds are allocated to the University of California and administered by Dr. Oswald Steward of the Reeve-Irvine Research Center at the University of California, Irvine. To date, more than 300 Californians have participated in 120 research projects. Each year, scientists in the spinal cord injury research arena gather at a “Meet the Scientists” forum sponsored by the program to discuss the best methods to collaborate on creative spinal cord research.
The struggle for cure continues.
Our hearts are filled with pride for Geron, with respect for the vision and tenacity of all connected– and with hope.
Karen Miner, wheelchair warrior and patient advocate, put it best: “This is what we have been working toward all these years.”
Spinal cord injury is the very symbol of that which is incurable: the first mention of spinal cord injury was on the walls of an Egyptian tomb: of paralyzed soldiers, the pictograms said, deny them water; let them die—there is nothing that can be done. That was true then: but not now.
The first step in the Geron trials is safety; we all know that. We understand that it had to take almost nine years between the first success in the laboratory—and now.
There will undoubtedly be glitches in the process. Things will go wrong. They always have; that is the nature of medical progress.
We have to walk before we can run. But now, we can take that first step at last.
Following is the historic announcement.
*July 30, 2010, 7:30 a.m. EDT · Recommend · Post:
Geron to Proceed with First Human Clinical Trial of Embryonic Stem Cell-Based Therapy
Geron to Study GRNOPC1 in Patients with Acute Spinal Cord Injury
MENLO PARK, Calif., Jul 30, 2010 (BUSINESS WIRE) — Geron Corporation /quotes/comstock/15*!gern/quotes/nls/gern (GERN 5.36, +0.56, +11.67%) announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the clinical hold placed on Geron’s Investigational New Drug (IND) application has been lifted and the company’s Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed.
The FDA notification enables Geron to move forward with the world’s first clinical trial of a human embryonic stem cell (hESC)-based therapy in man. The Phase I multi-center trial is designed to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries.
“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.”
Additional information on Geron’s hESC programs and GRNOPC1 is available at Geron’s website www.geron.com.
Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials in different cancers. For more information, visit www.geron.com.
SOURCE: Geron Corporation
Anna Krassowska, Ph.D., 650-473-7765
Investor and Media Relations