Neuralstem gets ok from FDA
Neuralstem, a company that has a stem cell procedure to use on ALS has been given the green light for stage 1 testing on humans. The trial has 12 patients that will each get injections in the lumbar portion of their spine. This test is primarily to guarantee the safety of the drug over a known amount of time. Each patient will be watched for signs of problems or rejection of the genetic material. Depending on how the 12 subjects do on this first test 9 on human subjects will determine if the FDA moves ahead to stage 2 testing, which is a larger group that tries to verify that the drug actually performs as advertised. This testing bodes well for Neuralstem as they are the first out the gate with a stem cell treatment to a form of spinal cord injury. If it makes it through all stages of testing, we will see if doctors are willing to see it on subjects that have injuries coming from physical injuries like diving accidents. (Source: Reuters)
Neuralstem is hoping that their stem cells will be both safe and effective. The idea is that the stem cells are to be injected into a patient at the damage site and then allowed to grow into whatever is needed in the spine. It is hoped that nerves that were damaged are replaced with new nerves that connect the nerves above and below the injury level. This would then allow the brain to control muscles that were previously controlled by nerves before the injury. Note that the patient will still need to go through extensive therapy even if this procedure is an unqualified success. However, it is still an important study for the spinal cord injury community because it is the first that has made it to human testing. If the test is found to be safe then it can be moved to phase two where effectiveness is verified.
This is a far cry of some hospitals in the far east that allow patients to pay for a large number of procedures that are reported to repair spinal cord damage. These procedures do not have the testing that is required from western governments so these are little more than experimentation on humans directly. While some report that they are able to move arms and legs that they could not do before, most find that they are in more pain. Some patients return with strong bacterial infections that are difficult to treat and may do even more damage than the original injury. While it is hard to wait for results it is strongly recommended that patients stay away from these medical vacation spots until more is known about their procedures and outcomes.
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User Comments
Mahrokh;
We are sorry that doctors in Iran do not know how to properly treat spinal cord injuries. The only information we can give you is to get to a western country that has good doctors. Western Europe, the United States and Japan all have excellent doctors and hospitals for those with spinal cord injuries. Don’t wait – the longer you wait to get care the worse your injury will be. Find a way to get to a good western hospital, preferably one that is a teaching hospital with a university nearby is the best solution. Note that there are no cures for spinal cord injuries, there are therapies that can help you get better movement and reduce pain, but you will probably not get your level of movement that you had before the injury.
Good luck.
Greg George
CEO
Spinal Cord Resources Network
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hello
this is Mahrokh. unfortunetly I am from Iran. We don’t have treatment for spinal cording injury here.
I had an accident by car 3 years age.I’m 23 years old and my life is terrible here.
Sorry,I know that my english is not good. but help me if you can.here they say lie about everything, the doctors,here, told that we find the treatment,the people who had this problem went and did another surgry but……
please help me if you can……..
please answer to my message.
thaank you