Thanks to the help of a new robotic exoskeleton created by Rice University, patients suffering from incomplete spinal cord injuries may have a tool to accelerate recovery for mobility issues related to the forearm and wrist. [Read more...]
The first patient to receive a human embryonic stem cell injection in October last year has reported increased feeling in his legs.
Where the patient, Timothy J. Atchison previously had no sensation at all, he now feels slight relief when a bowling ball is lifted from his lap and slight discomfort when hair on his legs is pulled.
This patient was the first in the clinical trial of this new stem cell treatment for people with acute spinal cord injuries.
Report Unofficial, Results May Be Unrelated to Treatment
The report is unofficial and researchers are emphasizing that it is far too early in the trial to make any conclusions about the effectiveness of the treatment.
Hans Keirstead, the stem cell researcher who invented the treatment used on the patient, is optimistic about the news, but emphasizes that this patient’s impressions will have no bearing on the official report on clinical trial results.
Experts are stressing that spinal cord injury patients sometimes regain sensation and mobility on their own, so it is impossible to determine if the treatment is effective based on one patient’s experiences.
Clinical Trial Will Move Forward, Effectiveness Still to be Tested
This first trial is simply aiming to determine the safety of the procedure and the tolerance levels patients exhibit. The actual effectiveness of the treatment will be evaluated in another clinical trial in the future.
At the Will2Walk Foundation, we seek to make life better for spinal cord injury survivors until a cure is found. To help us further our cause, please donate to Will2Walk today.
UCSF-UC Berkeley launches the Center for Neural Engineering & Prostheses
Last December, University of California Berkley and San Francisco launched the Center for Neural Engineering & Prostheses, where clinicians, engineers, and students from both campuses will collaborate on the research and development of new neural prosthetic technology.
Solutions for spinal-cord injury
Researchers at CNEP are trying to create prostheses that patients can control with their brains, using undamaged neural circuits to transmit messages to robotic arms, legs, or computer cursors.
Electrodes can be planted into a patient’s brain or above his or her spinal cord, where they rapidly read brain signals and translate them into commands for the prosthesis.
This technology could allow survivors of neurological injury, including spinal cord injury, the opportunity to move or communicate in a range of new ways.
Currently, the cochlear implant is the only commercially available neural prosthesis, but its success among hearing-impaired patients shows that the brain is capable of adapting to and interacting with these artificial devices.
A 2009 study of primate brains at UC Berkeley proves that the brain can also develop the motor memory to control a prosthetic limb.
The other goal of CNEP is to train future clinicians and neural engineers; students in the UCSF-UC Berkeley Joint Bioengineering Graduate Program can specialize in engineering, neuroscience, and clinical medicine.
In order for people with spinal cord injuries to take advantage of advancements in prostheses or any other treatment, they must keep physically fit. Volunteer with Will2Walk to help spread the message of health and fitness!
A recent case study in the International Archives of Medicine reports success in a case study that combines cellular therapies for spinal cord injury treatment.
The patient, a 29-year-old male with an L1 crush fracture of the vertebral body, received stem cell therapy of umbilical cord matrix and allogeneic umbilical cord blood at 5 months, 8 months, and 14 months after his injury.
No adverse effects were noted and the treatments were well tolerated.
The patient recovered muscle, bowel, and sexual function and experienced a decrease in pain from recurring 10/10 level to occasional pain intensity of 3/10.
To read more, please see the original journal article, Feasibility of combination allogeneic stem cell therapy for spinal cord treatment: A case report.
To take advantage of medical breakthroughs, we believe that the injured must maintain excellent fitness and health. Won’t you help us share this message by volunteering your time today? Volunteer with Will2Walk.
AFP International reports that Japanese researchers have restored mobility in a monkey that was paralyzed from the neck down.
Hideyuki Okano of Tokyo’s Keio University said:”It is the world’s first case in which a small-size primate recovered from a spinal injury using stem cells.”
Dr. Okano’s researchers injected induced pluripotent stem cells (iPS) into a paralyzed marmoset on the ninth day after the injury.
Within two to three weeks, the monkey began moving its arms and legs. After six weeks, the marmoset was jumping again, close to a normal activity level.
To learn more, please see the AFP news bulletin, Japan team say stem cells helped monkey jump again, to learn more.
We believe that cures for spinal cord injuries are on the horizon. Please help us make a difference in the lives of people waiting for a cure by donating to Will2Walk now.
U.K. Engineering and Physical Sciences Research Council breakthrough may help people with spinal cord injuries
The United Press International reports that British scientists have created a fingernail-sized microchip implant that will help exercised paralyzed muscles.
This is the first such device that is small enough to be implanted in the vertebral canal. It incorporates muscle simulators and electrodes in one unit.
According to Andreas Demosthenous of the Department of Electronic and Electrical Engineering at the University College in London, “The work has the potential to stimulate more muscle groups than is currently possible with existing technology because a number of these devices can be implanted into the spinal canal.”
Please see the original article, Implant can exercise paralyzed muscles, to learn more.
The first person ever received a human embryonic stem cell injection Monday, Oct. 11, announces Geron Corporation
After years of animal trials, the first human was injected with human embryonic stem cells Monday, initiating the first clinical trial by Geron Corporation, CNN reports.
“This is the first human embryonic stem cell trial in the world,” Geron President/CEO Dr. Thomas Okarma told CNN.
Geron’s clinical trial aims to assess patient reaction to the stem cell therapy during treatment of spinal cord injury
The primary objective of Geron’s study, according to a company press release, is to “assess the safety and tolerability” of a group of human embryonic stem cell-derived injection called GRNOPC1 in patients with new complete thoracic spinal cord injuries, rendering them paraplegic from the chest down.
CNN reports those with such an injury can still move their arms and breathe independently, they cannot control their bowel or bladder nor can they move their legs. Also, according to CNN, there is no hope for recovery through physical therapy.
In order to be eligible for participation in the study, patients must receive the GRNOPC1 injection within one to two weeks of injury, according to Geron’s statement.
The first patient to receive the GRNOPC1 injection was treated at Shepherd Center, a spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta and one of seven facilities that may enroll patients in the clinical trial, Geron announced.
What is GRNOPC1?
GRNOPC1 is a set of embryonic stem cells that have been “coaxed into becoming early myelinated glial cells, a type of cell that insulates nerve cells,” CNN reports. The injected cells multiply to replace the tissue lost in the injury, which Okarma explained to CNN, is like “repairing a large electrical cable.”
In the case of a spinal cord injury, these new stem-cell derived glial cells creep in between all the fibers and rewrap the nerve with myelin, which is like patching the cable. The goal is to permanently repair the damage that caused the paralysis from the spinal cord injury.
“We’re not treating symptoms here - we’re permanently regenerating tissue,” says Okarma.
“A milestone” in human embryonic stem cell-based therapy
“Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies,” Okarma said in the press release. “When we started working with hESCs in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials.”
According to CNN, the FDA first approved Geron’s trial in January 2009, then required further research before giving the company final approval in July of this year. While controversial, CNN reports the GRNOPC1 therapy is derived from stem cells that were harvested from leftover embryos from fertility clinics and “zero federal funds” were used in its development.
Geron’s ultimate goal, according to CNN, “is to shift the outcome for someone who has just suffered a serious spinal cord injury, and go from a place where there’s no hope for improvement to a situation where they can respond to physical therapy.”
“If we could do that, this would be a spectacular result,” Okarma told CNN.
See the full story from CNN, including video and ensuing debate, here.
What is SCINETUSA?
SCINETUSA is a clinical trial network of cutting edge spinal cord injury centers in the United States. SCINETUSA supports and conducts clinical trials of the newest promising therapies for chronic spinal cord injury in the United States.
What are the newest trials being tested?
The initial trials that the network are proposing to test are:
A Phase 2 trial to examine the safety and likelihood of umbilical cord blood mononuclear cells (UCBMC that are HLA-matched at least 4:6) transplanted into the spinal cord above and below the injury site, to be followed by a 6-week course of lithium, and randomized to a 3-month course involving overground locomotor training.
This trial will have 20 patients. The main goals of the trial will be to examine adverse events, viability of locomotor training, and neurological scores at 6 weeks, 6 months, and a year.
All the subjects must be ASIA A, have neurological levels between C5 and T10 (inclusive), at least a year after injury without significant medical problems that would interfere with the surgery, and be able to stand (weight-bearing) for at least an hour in a standing frame.
A Phase 3 trial to determine and compare the value of rehabilitation alone (overground locomotor training), lithium alone, UCBMC transplants alone, and UCBMC plus lithium treatment of subjects with chronic spinal cord injury.
A total of 240 subjects (age 18-64, C5-T10 inclusive) with chronic spinal cord injury (at least one year after injury, with stable neurological function) will be randomized to the four treatment groups.
The results examined will be motor and sensory scores (ASIA), locomotor score (WISCI), independence score (SCIM), and adverse events of each of the treatments.
If the results in these trials are promising, Phase 2 trials will be begun to extend the treatment to older subjects (age 65-80), younger subjects (age 8-17), higher quadriplegics (C1-C4), and lower lumbosacral injuries (T11-L1).
Patients will not be charged for the therapies.
Who is participating?
The centers that have shown interest in participating in these trials include:
- Brackenridge Hospital, Austin, TX
- University of Medicine & Dentistry of NJ at Newark & Kessler
- Mt. Sinai School of Medicine, New York
- Long Island Jewish Hospital, New York
- Kent State University & Rehab. Inst. of Michigan, Detroit
- Shephard Rehabilitation Center, Atlanta
- University of Colorado at Denver
- Shriner’s Hospital in Philadelphia
Currently, a network in China (ChinaSCINet) is carrying out Phase 2 trials to evaluate the effects of escalating doses of UCBMC.
In 2011, ChinaSCINet and SCINETUSA are planning to execute their phase 3 trials in parallel (Note: The U.S. FDA requires two trials in parallel to approve therapies.)
Both ChinaSCINet and SCINETUSA will test the most promising therapies for chronic spinal cord injury rigorously, in clinical trials that meet the highest medical, ethical and scientific research standards.
These trials are also being considered in India and Norway, as well as in other centers in the U.S.
Just the beginning!
UCBMC and lithium are the first therapies that will be tested by these networks. If the combination of UCBMC and lithium together is effective, other therapies will be tested in comparison.
The a relatively new technique called induced pluripotent stem cells (IPS cells) could be the breakthrough needed to reinvigorate stem cell research and give hope to the millions of Americans suffering debilitating diseases.
Perhaps its biggest saving grace is that it holds the potential to sidestep the moral and ethical concerns raised by other research techniques.
There are currently three sources of stem cells for research. The first is embryonic stem cells derived from human embryos created in the process of in vitro fertilization. Due to the low success rates, excess embryos are routinely created in fertility clinics. Once a couple successfully becomes pregnant, the remaining embryos must be discarded, donated to other couples, frozen or used for research. Due to a variety of concerns most are simply discarded. However, those cells used for research are particularly powerful as they are capable of developing into any of the 220 different types of human cells.
Adult stem cells are derived from adult subjects. Unfortunately, these adult cells are very difficult to harvest and are very limited in number. More importantly adult stem cells are much less powerful than embryonic cells in that they can only develop into very few types of human cells. This severely limits their usefulness in treating disease.
A third source of stem cells has only recently been developed but shows great promise. These induced pluripotent stem cells or IPS cells are derived from adult cells such as skin cells. The process involves the use of viruses to insert human DNA into ordinary adult cells causing them to mimic the properties of embryonic stem cells. The outcome could have a massive impact on stem cell research since IPS cells have the flexibility and potential range of applications of embryonic stem cells without the ethical concerns.
What is less obvious is that we are all hurt by the injury. How? Consider the costs. There are currently 1.3 million individuals in the United States living with a spinal cord injury. To that number, an estimated 10,000-14,000 are added each year. When you combine these numbers with the fact that the average age at the time of injury is 30 years old, the annual cost to society is estimated at $8 billion. How about we find a cure for spinal cord injury and put the $8 billion back in our pockets?