First FDA Approved Human Stem Cell Trial Begins in Atlanta
posted on Oct 12 by Sherri in the Disability News, Health, Healthcare, Paralysis Cures, Spinal Cord Injury, Technology category
October 11, 2010 turned out to be a watershed moment in the treatment of spinal cord injuries, as Atlanta’s Shepherd Center became the first facility in the United States to host a human trial of embryonic stem cell research. In collaboration with Silicon Valley-based Geron Corporation, Shepherd Center surgeons have successfully injected the trial’s first patient with about 2 million “human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells,” also known as GRNOPC1, in the hopes that the cells will form a restorative coating around the damaged spinal cord.
“We are pleased to have our patients participating in this exciting research,” said Donald Peck Leslie, M.D., medical director, Shepherd Center. “Our medical staff will evaluate the patients’ progress as part of this study. We look forward to participating in clinical trials that may help people with spinal cord injury.”
The Geron study has been lauded by excited scientists and patient advocates alike, who have longed for stem cell clinical trials to move out of the laboratory and on to actual patients. That excitement has been intensified in light of similar testing on hundreds of rats, resulting in partially paralyzed animals regaining the ability to walk.
It should be noted, however, that although doctors will be conducting tests to see whether the treatment restores sensation or enables the patient to regain movement, Geron has clearly stated that this Phase I trial will not be aiming to cure patients. The company eventually hopes to test the cells for many different medical problems, but this first trial will focus only on testing the “safety and tolerability” of stem cells on patients with new spinal cord injuries and will involve 10 patients who were partially paralyzed by a spinal cord injury in the one to two weeks prior to their enrollment in the study.
The biggest leap forward here comes from the fact that the Geron trial is the first to have been fully vetted by a government entity. In a press release published yesterday, Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO stated that, “Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies.”
According to a Reuters article, Geron is not subject to limitations on federal funding for human embryonic stem cell research, because it is a privately funded company. Although it does not have government funding, what Geron does have is the very first U.S. Food and Drug Administration license to use human embryonic stem cells to treat people. The only one other company with a human stem cell treatment close to FDA approval is Massachusetts-based Advanced Cell Technology.
David Apple, M.D., Shepherd Center’s medical director emeritus and principal investigator of the trial at Shepherd Center added, “This clinical trial represents another step forward in Shepherd Center’s involvement in an attempt to find a cure for paralysis in people with spinal cord injury. Shepherd Center is an ideal place to conduct this study because of our clinical expertise and the volume of patients referred here for rehabilitation care.”
Shepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury and brain injury. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. Shepherd is one of seven sites participating in the study and is located mere minutes from the nationwide home office for AMS Vans, Inc., an Atlanta wheelchair van dealership.
For more information regarding the Geron study, the press release states:
In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is also open for patient enrollment. As additional trial sites come online and are ready to enroll patients, they will be listed on the Patient Information pages of Geron’s website and on the NIH clinical trials registry, ClinicalTrials.gov. Further information on the criteria for patient eligibility for the study is also available on ClinicalTrials.gov.
19 Comments
World Wide News Flash, posted this comment on Oct 12th, 2010
First FDA Approved Human Stem Cell Trial Begins in Atlanta ……
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Rita Roper, posted this comment on Oct 12th, 2010
Does this work for MS patients? Please let me know, thanks.
First FDA Approved Human Stem Cell Trial Begins in Atlanta … - Chicago Illinois News, posted this comment on Oct 13th, 2010
[...] Read the rest of this news story here [...]
Sherri, posted this comment on Oct 13th, 2010
For this particular study, they”re only looking at very recent spinal cord injuries (enrollment in study within 7-17 days after injury). However, Geron may be a company to watch for future trials regarding MS and other illnesses and injuries. If we see anything new from them in the future, we”ll be sure to report it!
Robert L. Burt, posted this comment on Oct 13th, 2010
my sister Karen Burt and my self was in a bad car accident, which left her paralysis from the nake down.I have read about your center and would like to know about your enrollment for people with spinal cord injury.we live in new york. could you give me any infomation, mainly if you take people like my sister. my home phone number is (518)337-3149, please get back with me as soon as possible. I think you for your time in this matter.
Sherri, posted this comment on Oct 13th, 2010
AMS Vans is not affiliated with the trial, but you can find out more about the trial by visiting Geron”s clinical study information page at http://www.geron.com/patients/clinicaltrials/hESC.aspx and by visiting the ClinicalTrials.gov link to the study at http://clinicaltrials.gov/ct2/show/NCT01217008?term=GRNOPC1&rank=1. Hope that helps!
Ken Walker, posted this comment on Oct 14th, 2010
I have M.S. and also a spinal cord injury caused by a steroid injection forming a blood clot in spinal cord causing paralysis from L4. Will someone with these conditions be admitted to the trial?
Sherri, posted this comment on Oct 18th, 2010
From our understanding of the trial, it is being very limited to 10 patients who received their spinal cord injury within 7-14 days of entering the trial. Geron Corporation may have further trials in the future, however, so it would be worth keeping an eye on them. If learn of any news related to other studies like this in the future, we will be sure to report it here.
CARL SUTTON, posted this comment on Oct 19th, 2010
This is not the first stem cell trial on humans. The Texas trial for the heart was started a year ago. The FDA/NIH never say anything about the human stem cell trial results. They don’t want patients to be cured, they would rather feed them pills from thier lab friends. Why is it that they don’t advertise any success stories? People have been getting cured for years overseas but they still keep progress here form being made.
CARL D SUTTON, posted this comment on Oct 19th, 2010
This is not the first FDA approved clinical trial using stem cells. The Texas Heart Institute has been doing them for a year already. The FDA/NIH hide the results of any positive out comes. I suppose it’s because they don’t like to have people cured. They would rather feed them pills How many patients have been treated for thier heart disease? Have any been positive?
Sherri, posted this comment on Nov 19th, 2010
Technically, you are correct, Carl; this is not the first stem cell trial. Its actually referred to as being “the first government sponsored embryonic stem cell trial on spinal cord injuries,” and only since the ban has been lifted. You also raise some very valid questions. Please keep asking those hard questions and hopefully we will begin to see even more movement in this area.
adam, posted this comment on Jan 10th, 2011
i was in an accident when i was 19. since then, i have been regainning functions from different parts of my body. bowl, bladder,and some feeling in different parts of my body.it’s been 13 years since my accident, and it would be nice to get some of what i lost back. people who say this is a bad thing, i say ” TRY LIVING WHAT YOU PREACH.”
josephine hefner, posted this comment on Feb 9th, 2011
INTERESTED ON MS STEM CLINICAL TRIALS
dave, posted this comment on Feb 11th, 2011
Does anyone have any news on the first patient treated with GRNOPC1, embryonic stem cells?
Fourth Paralyzed Patient Enters Geron Stem Cell Study | Wheelchair Accessibility Blog and Disability News, posted this comment on Oct 11th, 2011
[...] the study, with the first one already enrolled in October 2010 (see our previous blog post: “First FDA Approved Human Stem Cell Trial Begins in Atlanta“). The first three patients were reportedly doing well and so far experienced no side [...]
Damone, posted this comment on Oct 21st, 2011
Hello,
due to a cervical spinal cord injury at the level of C5 I”m living life as a quadriplegic, and I hope and pray for those and others such as myself that the knowledge of stem cell research be put into action very soon if it”s proven to be a cure for (SCI) spinal cord injuries which I believe it is. The physical and mental suffering from a spinal cord injury and quality of life of being dependent on others is excruciating for some of us. I very much want to be Involved in a Geron stem cell study for quadriplegics or an FDA approved company that”s doing human clinical trial studies. I”m willing to relocate to be closer to recieve treatment. So please consider me because at this point in my life I”m just holding on to what I have which is not much except for God and my hopes and prayers.
Sincerely,
Damone
Rovane Timmons, posted this comment on Nov 28th, 2011
I was in a bad go-kart accident back in 1975, I suffered severe brain injuries. I am now 45 years old, I walk with a walker and use a wheelchair at times to shop in stores. Does this hospital do anything for brain injuries.
Thanks Rovane
Sherri, posted this comment on Nov 28th, 2011
Yes, it does appear that the Shepherd Center works with brain injuries, too. This link might be helpful to you: http://www.shepherd.org/patient-care/brain-injury
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