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    Stem cell treatment causes nasal growth in woman's back

    http://www.newscientist.com/article/...1#.U7v-8vldV1a

    A woman in the US has developed a tumour-like growth eight years after a stem cell treatment to cure her paralysis failed. There have been a handful of cases of stem cell treatments causing growths but this appears to be the first in which the treatment was given at a Western hospital as part of an approved clinical trial.

    At a hospital in Portugal, the unnamed woman, a US citizen, had tissue containing olfactory stem cells taken from her nose and implanted in her spine. The hope was that these cells would develop into neural cells and help repair the nerve damage to the woman's spine. The treatment did not work ? far from it. Last year the woman, then 28, underwent surgery because of worsening pain at the implant site.

    The surgeons removed a 3-centimetre-long growth, which was found to be mainly nasal tissue, as well as bits of bone and tiny nerve branches that had not connected with the spinal nerves.

    The growth wasn't cancerous, but it was secreting a "thick copious mucus-like material", which is probably why it was pressing painfully on her spine, says Brian Dlouhy at the University of Iowa Hospitals and Clinics in Iowa City, the neurosurgeon who removed the growth. The results of the surgery have now been published.

    Unpredictable consequences

    "It is sobering," says George Daley, a stem cell researcher at Harvard Medical School who has helped write guidelines for people considering stem cell treatments. "It speaks directly to how primitive our state of knowledge is about how cells integrate and divide and expand. "

    The case shows that even when carried out at mainstream hospitals, experimental stem cell therapies can have unpredictable consequences, says Alexey Bersenev, a stem cell research analyst who blogs at Cell Trials. "We have to realise complications can also happen in a clinical trial," he says.

    Stem cells have the prized ability to divide and replenish themselves, as well as turn into different types of tissues. There are several different stem cells, including ones obtained from an early embryo, aborted fetuses, and umbilical cord blood. There are many sources within adult tissues, too, including bone marrow.

    While often hailed as the future of medicine, stem cells' ability to proliferate carries an inherent danger and the fear has always been that when implanted into a person they could turn cancerous.

    Lawsuits abound

    Still, a few stem cell therapies have now been approved, such as a treatment available in India that takes stem cells from the patient's eye in order to regrow the surface of their cornea, and a US product based on other people's bone stem cells.

    Many groups around the world are investigating a wide range of other applications, including treating heart attacks, blindness, Parkinson's disease and cancer. Research groups at universities and hospitals need to meet strict safety guidelines for clinical trials but some small private clinics are offering therapies to people without research or marketing approval. There is a growing number of lawsuits against such clinics and a few cases have been reported of tumours or excessive tissue growth (see "Ongoing stem cell trials" below).

    When the Italian government tried to ban an unproven stem cell therapy for neurological disorders, the treatment's supporters ? families of people receiving the therapy who thought it was working ? protested in the street.

    Following the nose

    The woman at the centre of today's news was treated at the Hospital de Egas Moniz in Lisbon, where a team got approval for early-stage trials to explore the potential of nasal cells in treating paralysis. Tissue at the top of the nasal passages contains both neural-stem-cell-like cells and "olfactory ensheathing cells", which support and guide the growth of the neurons.

    Other groups are experimenting with taking such tissue from the nose, growing it in the lab to isolate the desired cells and transplanting them. But the Lisbon clinic was trialling a procedure that bypassed this isolation step. They took small pieces of the nasal lining and directly transplanted them into their patients' spines. That could be why it retained its capacity to make mucus, says Dlouhy.

    In 2010, the Lisbon researchers published their results using this method on 20 people paralysed at various locations in their spine. Eleven experienced some recovery of movement or sensation; one person's paralysis got worse, one developed meningitis and four others experienced minor adverse events. It is not clear whether the woman from the US was part of this trial.

    Extreme vigilance

    New Scientist was unable to reach the Lisbon team members, but Jean Peduzzi-Nelson, a stem cell researcher at Wayne State University in Detroit, Michigan, who advised the team on their surgical technique ? she had previously tested it on rodents ? claims the clinic has given the therapy to about 140 people in total.

    Peduzzi-Nelson adds that most of the recipients of the nasal tissue who received the right kind of rehabilitation after their surgery experienced improvement. "I am saddened to learn of this adverse event, however, the incidence of this problem is less than 1 per cent," she says. "Many patients receiving this treatment have had remarkable recovery."

    But the case shows that even patients who feel they have nothing to lose should be cautious, says Leigh Turner of the University of Minnesota in Minneapolis, who tracks lawsuits involving stem cell therapies. "We still need to think in terms of risks and benefits."

    Daley points out that many trials track their patients for only a few years, so could miss such delayed problems. "We need to be extremely vigilant and we need extremely long-term follow-up," he says.
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

    #2
    very interesting

    Thanks for the post very interesting story My question is this, are there any success stories, positive outcomes from any stem cell trial or therapy thus far. It seems stories like this one surface now and then but Ive never seen a positive story posted,maybe I missed it. Just curious


    Originally posted by ineedmyelin View Post
    http://www.newscientist.com/article/...1#.U7v-8vldV1a

    A woman in the US has developed a tumour-like growth eight years after a stem cell treatment to cure her paralysis failed. There have been a handful of cases of stem cell treatments causing growths but this appears to be the first in which the treatment was given at a Western hospital as part of an approved clinical trial.

    At a hospital in Portugal, the unnamed woman, a US citizen, had tissue containing olfactory stem cells taken from her nose and implanted in her spine. The hope was that these cells would develop into neural cells and help repair the nerve damage to the woman's spine. The treatment did not work ? far from it. Last year the woman, then 28, underwent surgery because of worsening pain at the implant site.

    The surgeons removed a 3-centimetre-long growth, which was found to be mainly nasal tissue, as well as bits of bone and tiny nerve branches that had not connected with the spinal nerves.

    The growth wasn't cancerous, but it was secreting a "thick copious mucus-like material", which is probably why it was pressing painfully on her spine, says Brian Dlouhy at the University of Iowa Hospitals and Clinics in Iowa City, the neurosurgeon who removed the growth. The results of the surgery have now been published.

    Unpredictable consequences

    "It is sobering," says George Daley, a stem cell researcher at Harvard Medical School who has helped write guidelines for people considering stem cell treatments. "It speaks directly to how primitive our state of knowledge is about how cells integrate and divide and expand. "

    The case shows that even when carried out at mainstream hospitals, experimental stem cell therapies can have unpredictable consequences, says Alexey Bersenev, a stem cell research analyst who blogs at Cell Trials. "We have to realise complications can also happen in a clinical trial," he says.

    Stem cells have the prized ability to divide and replenish themselves, as well as turn into different types of tissues. There are several different stem cells, including ones obtained from an early embryo, aborted fetuses, and umbilical cord blood. There are many sources within adult tissues, too, including bone marrow.

    While often hailed as the future of medicine, stem cells' ability to proliferate carries an inherent danger and the fear has always been that when implanted into a person they could turn cancerous.

    Lawsuits abound

    Still, a few stem cell therapies have now been approved, such as a treatment available in India that takes stem cells from the patient's eye in order to regrow the surface of their cornea, and a US product based on other people's bone stem cells.

    Many groups around the world are investigating a wide range of other applications, including treating heart attacks, blindness, Parkinson's disease and cancer. Research groups at universities and hospitals need to meet strict safety guidelines for clinical trials but some small private clinics are offering therapies to people without research or marketing approval. There is a growing number of lawsuits against such clinics and a few cases have been reported of tumours or excessive tissue growth (see "Ongoing stem cell trials" below).

    When the Italian government tried to ban an unproven stem cell therapy for neurological disorders, the treatment's supporters ? families of people receiving the therapy who thought it was working ? protested in the street.

    Following the nose

    The woman at the centre of today's news was treated at the Hospital de Egas Moniz in Lisbon, where a team got approval for early-stage trials to explore the potential of nasal cells in treating paralysis. Tissue at the top of the nasal passages contains both neural-stem-cell-like cells and "olfactory ensheathing cells", which support and guide the growth of the neurons.

    Other groups are experimenting with taking such tissue from the nose, growing it in the lab to isolate the desired cells and transplanting them. But the Lisbon clinic was trialling a procedure that bypassed this isolation step. They took small pieces of the nasal lining and directly transplanted them into their patients' spines. That could be why it retained its capacity to make mucus, says Dlouhy.

    In 2010, the Lisbon researchers published their results using this method on 20 people paralysed at various locations in their spine. Eleven experienced some recovery of movement or sensation; one person's paralysis got worse, one developed meningitis and four others experienced minor adverse events. It is not clear whether the woman from the US was part of this trial.

    Extreme vigilance

    New Scientist was unable to reach the Lisbon team members, but Jean Peduzzi-Nelson, a stem cell researcher at Wayne State University in Detroit, Michigan, who advised the team on their surgical technique ? she had previously tested it on rodents ? claims the clinic has given the therapy to about 140 people in total.

    Peduzzi-Nelson adds that most of the recipients of the nasal tissue who received the right kind of rehabilitation after their surgery experienced improvement. "I am saddened to learn of this adverse event, however, the incidence of this problem is less than 1 per cent," she says. "Many patients receiving this treatment have had remarkable recovery."

    But the case shows that even patients who feel they have nothing to lose should be cautious, says Leigh Turner of the University of Minnesota in Minneapolis, who tracks lawsuits involving stem cell therapies. "We still need to think in terms of risks and benefits."

    Daley points out that many trials track their patients for only a few years, so could miss such delayed problems. "We need to be extremely vigilant and we need extremely long-term follow-up," he says.

    Comment


      #3
      This really makes the case for long term follow of patients/ GMP protocols.

      Comment


        #4
        Originally posted by Tbone57 View Post
        Thanks for the post very interesting story My question is this, are there any success stories, positive outcomes from any stem cell trial or therapy thus far. It seems stories like this one surface now and then but Ive never seen a positive story posted,maybe I missed it. Just curious
        Yes there are.
        Last edited by ineedmyelin; 8 Jul 2014, 11:13 AM. Reason: typo
        "I'm manic as hell-
        But I'm goin' strong-
        Left my meds on the sink again-
        My head will be racing by lunchtime"

        <----Scott Weiland---->

        Comment


          #5
          Exactly the reason why I would wait a couple years after a 'fix/cure" was being performed.
          And this is part of the reason why so many are hesitant to be involved in cure work because idiots jump the gun with hope and when it doesnt work out as they hoped, lawsuit after lawsuit.

          Comment


            #6
            This is one of Carlos Lima's patients from Le Moniz Hospital in Lisbon. Dr. Lima, who died several years ago, probably transplanted 140-160 patients. We have had extensive discussion of this treatment on these forums. I list several threads below, including a poll to which 19 CareCure members responded regarding whether they had any benefit from the nasal mucosa transplant. Of course, this poll is not scientific but about 16% of the people who responded indicated that they had substantial improvement, 37% said that they had slight improvement.
            http:///forum/showthread.php?17817-J...a%2C+olfactory

            There is always a danger when one is transplanting whole tissues into the spinal cord that some of the transplanted tissues will grow. While this growth was deemed to be "cancerous", any time you have cells that produce the wrong number and type of cells in the spinal cord, it is a tumor, which is an abnormal growth. Despite all the hoopla, reports of tumors growing from cell transplants have been remarkably rare. It is hard to know how many patients have received fetal cell transplants but I suspect that thousands have received such transplants in the last 30 years and we have only two reported case of tumor growth.

            The article has an interesting side-bar entitled "Ongoing stem cell trials", pointing out three cases where there was confirmed tumorous growth of transplanted cells. One was a Parkinson's patient who received fetal cell transplants in China, who developed a teratoma in his brain on autopsy. Another is a young patient who died from brain and spinal tumors that developed after having received multiple fetal cell transplants into the brain but it should be pointed out that this patient was being treated for a genetic disease that leads to a propensity for brain tumors. A third case is a 46-year old woman who developed multiple tumors of the kidneys after having received her own bone marrow to treat her renal failure.

            The side-bar also described 3 cases of people developing leukemia after receiving stem cells from umbilical cord blood transplants. The author suggests that this is not surprising, since ordinary bone marrow transplants also carry that risk (like this woman above who received her own bone marrow cells also developed tumors). Probably over 50,000 people have received umbilical cord blood cell transplants over the last 25 years (since the first umbilical cord blood transplant in 1988), many of whom were being treated with umbilical cord blood for leukemia. Three cases out of 50,000 is 0.006% of patients that have umbilical cord blood transplants developed leukemia. This is not very different from the incidence of leukemia in the general population, about 75/million or 0.0075%.

            Wise.

            http:///forum/showthread.php?39751-O...isbon-Portugal
            http:///forum/showthread.php?64995-L...rst-7-patients

            Comment


              #7
              Dr. Young, have you seen this one?

              Spinal cord mass arising from neural stem cell therapy
              Date:
              July 8, 2014
              Source:
              Journal of Neurosurgery
              Summary:
              A spinal mass was found in a woman with complete spinal cord injury eight years after she had undergone implantation of olfactory mucosal cells to hopefully regain sensory and motor function. Authors caution that physicians should be vigilant in follow-up of patients who undergo stem cell interventions.
              spinal mass was identified in a young woman with complete spinal cord injury 8 years after she had undergone implantation of olfactory mucosal cells in the hopes of regaining sensory and motor function. The case is reported and discussed in "Autograft-derived spinal cord mass following olfactory mucosal cell transplantation in a spinal cord injury patient. Case report," by Brian J. Dlouhy, MD, Olatilewa Awe, MD, Rajesh C. Rao, MD, Patricia A. Kirby, MD, and Patrick W. Hitchon, MD, published today online, ahead of print, in the Journal of Neurosurgery. The authors state that this is the first report of a spinal cord mass arising from spinal cord cell transplantation and neural stem cell therapy, and they caution that physicians should be vigilant in their follow-up of patients who undergo stem cell interventions.
              In its natural state, the olfactory mucosa lines the roof of the nasal cavity, adjacent to the respiratory mucosa that lines the lower nasal cavity. In addition to smell receptor neurons, the olfactory mucosa contains progenitor cells (also known as adult stem cells) and olfactory ensheathing cells -- both of which have been shown to aid in the repair of the injured spinal cord in laboratory studies and in humans. The respiratory mucosa, on the other hand contains mucus-secreting goblet cells and mucus and serous fluid?-producing cells.
              more...
              http://www.sciencedaily.com/releases...0708091121.htm

              Oh! SORRY, I WAS IN A HURRY WHEN I POST IT AND I DID NOT SEE THAT ALL READY IS POSTED. PLEASE REMOVE IT. TY!

              Comment


                #8
                A friend had this reaction:
                To me it is interesting that cell proliferation of this type in stem cell studies is not MORE commonly reported. Given that in order to get these cells to grow in the laboratory there must be careful control of things like temperature, the nutritional media, the surface on which they are plated, etc, it seems that only the very strongest cells survive. And so if the cells are transplanted into the human cellular environment, which is so much less controlled, then it would seem the cells most likely to survive and grow would be those “cancerous” cells that have the greatest potential to grow unchecked.

                Comment


                  #9
                  Originally posted by c473s View Post
                  A friend had this reaction:
                  To me it is interesting that cell proliferation of this type in stem cell studies is not MORE commonly reported. Given that in order to get these cells to grow in the laboratory there must be careful control of things like temperature, the nutritional media, the surface on which they are plated, etc, it seems that only the very strongest cells survive. And so if the cells are transplanted into the human cellular environment, which is so much less controlled, then it would seem the cells most likely to survive and grow would be those ?cancerous? cells that have the greatest potential to grow unchecked.
                  Your friend's reaction is very insightful. On the other hand, it is important to point out how few cases of tumors have been observed after cell transplantation. Many thousands of people have received allogeneic (from one person to another) transplants of umbilical cord blood and bone marrow, probably well over 50,000. To have only three cases of leukemia in over 50,000 cases reported suggests that these cells do not have a tendency to form tumors. This may be due to two other factors. First, the immune systems of the recipients are killing off most of the transplanted cells, recognizing them as foreign. Second, the cells themselves have tight control of growth and are not responding to the environment by growing without control.

                  This is very different from when one transplants an embryonic stem cells (ESC) or induced pluripotent stem (iPS) cell into the animal. If one transplants embryonic stem cells or iPS into the spinal cord of a immune-compatible mouse (e.g. the cells are from the same strain of mouse), 9 or 10 times out of 10, the cells will produce a teratoma. The rat or mouse becomes paralyzed. If one transplants ESC or iPS into the spinal cord of a non-immune-compatible mouse or rat, i.e. cells from a different strain or even species, the transplanted cells are eliminated by the immune system within 4 weeks most of the time although some cells may still grow into a tumor. If one transplants a tumor cell line (many tumor cell lines are not recognized by the immune system), it usually will produce a tumor every time. So, even though it is true that cell transplantation tends to select out those cells that grow best in a particular environment and these may be cancerous cells, much depends on the type of cells being transplanted.

                  The U.S. Food and Drug Administration has set very stringent standards for transplantation of embryonic-stem-cell-derived cells into people. In order to gain approval for transplanting the H1 ESC line (the first stem cell line that was developed by Thomson in Wisconsin) into people with spinal cord injury, Geron had to show that less than 1 out of a billion cells became pluripotent in culture after differentiation and after transplantation into the spinal cord of immune-deficient mice. In other words, the FDA does not allow direct transplantation of embryonic stem cells or induced pluripotent stem cells into people. The cells must be terminally differentiated into the cells that one seeks to replace, such as neurons or liver cells. The investigators must demonstrated that less than 1 out of a billion cells will revert back to being stem cells in culture and does not produce tumors when transplanted into animals. I don't recall how many animals were required but I think that Geron did hundreds of animals.

                  In summary, there are three factors involved. The first is the immune system of the host. If the immune system is compromised either by immune suppression or disease, obviously the likelihood of cancer from transplanted cells is higher. The second is the propensity of the cells to grow out of control. Certain tumor cell lines grow so fast that the immune system cannot catch up. The third is the cells' ability to escape immune detection. This may be particularly true in the spinal cord, where the immune system is not as active and detection of foreign or cancerous cells is not as rapid.

                  Wise.

                  Comment


                    #10
                    Originally posted by Wise Young View Post
                    Your friend's reaction is very insightful. On the other hand, it is important to point out <snip>

                    The U.S. Food and Drug Administration has set very stringent standards for transplantation of embryonic-stem-cell-derived cells into people. In order to gain approval for transplanting the H1 ESC line (the first stem cell line that was developed by Thomson in Wisconsin) into people with spinal cord injury, Geron had to show that less than 1 out of a billion cells became pluripotent in culture after differentiation and after transplantation into the spinal cord of immune-deficient mice. In other words, the FDA does not allow direct transplantation of embryonic stem cells or induced pluripotent stem cells into people. The cells must be terminally differentiated into the cells that one seeks to replace, such as neurons or liver cells. The investigators must demonstrated that less than 1 out of a billion cells will revert back to being stem cells in culture and does not produce tumors when transplanted into animals. I don't recall how many animals were required but I think that Geron did hundreds of animals.

                    In summary, there are three factors involved. The first is the immune system of the host. If the immune system is compromised either by immune suppression or disease, obviously the likelihood of cancer from transplanted cells is higher. The second is the propensity of the cells to grow out of control. Certain tumor cell lines grow so fast that the immune system cannot catch up. The third is the cells' ability to escape immune detection. This may be particularly true in the spinal cord, where the immune system is not as active and detection of foreign or cancerous cells is not as rapid.

                    Wise.
                    I think you both in different ways point to the importance of purity, GMP and protocols. The cause would be wounded if we started seeing a lot of reports of "cancerous cells" or untended growths. I believe long term follow and very good imaging is important. Do you have a decent stab at how many you believe are followed closely 5 plus years out ?

                    Comment


                      #11
                      So, according to this story, in the race for a cure. Stem cell therepy wins by a nose!

                      Comment


                        #12
                        Here are some papers with good questions to ask about treatments or trials.
                        http://icord.org/research/iccp-clini...s-information/

                        Comment


                          #13
                          I had this same procedure done about 11 years ago, what symptoms should I be looking out for if I have got a growth, I'm worried now.

                          Comment


                            #14
                            Originally posted by kimg View Post
                            I had this same procedure done about 11 years ago, what symptoms should I be looking out for if I have got a growth, I'm worried now.
                            Originally posted by c473s
                            Do you have a decent stab at how many you believe are followed closely 5 plus years out ?
                            Kimg,

                            I will try to answer your questions and c473s' questions here. First, you should not worry about it. If you have no loss or change of function, including increased spasticity and neuropathic pain, you probably don't have any growth from your transplant. Second, it is good idea to get MRI's of your spinal cord every 2 years. You should ask your doctor to arrange this. The reason is because, if some function were to change or some pathology were to appear in your spinal cord, you want to know how long it has been there. Many changes can happen in the spinal cord after surgery, including extradural or syringomyelic cysts and change in white matter signal. Although it cannot detect all problems, MRI is the best way to assess changes in the spinal cord that exceed a mm in diameter. Third, one of the reasons why there have been relatively few reports of growth in the spinal cord after cell transplants is because the spinal cord (like much of the central nervous system) is not a fertile place to plant cells. Unless the transplants include cancer cells (which are cells with deranged growth control), they usually do not grow very much in the spinal cord and most simply disappear. Fourth, nasal mucosa does have stem cells and there have been reports of nasal tissues growing in the spinal cord of animals after transplantation of nasal mucosa. Such tumors are typically not invasive but can cause trouble due to compression of the spinal cord.

                            c473s, who will pay for such followup? Funds may become available for extended followup if the therapy were approved by the FDA. For example, the FDA requires companies to carry out long term followup (called phase IV trials) after a therapy has been approved. However, no cellular therapy has gone into phase 3 clinical trials for spinal cord injury and none have been approved to date. There is no company behind nasal mucosal transplants and thus little motivation for systematic long term followup. On the other hand, now that one patient has shown a nasal mucosal growth in the spinal cord, perhaps some investigators will be motivated to write a grant application to the NIH to fund a followup study of the patients that had received nasal mucosa transplants in Portugal. NIH grant applications are very competitive and I am skeptical that such a project will be able to get funding.

                            Autologous nasal mucosal transplants belong to a category of treatment that is not regulated by the FDA. It is not unlike taking a skin graft from one part of your body to treat another. Because it is not a "product" that is sold by a company, the FDA is unlikely to be involved. In such cases, only an Institutional Review Board (IRB) approval is necessary for the trial. Finally, I know of at least two other places where autologous nasal mucosa transplants into chronically injured spinal cords are being carried out. One is in Christ Church, New Zealand. The other is in Osaka, Japan. The latter trial, according to presentations that I have seen, suggests that there may be modest benefits. Before he died, Carlos Lima had reported that several patients from his study has recovered some walking after intensive rehabilitation in Greece. Note that none of the other trials have put their patients through intensive locomotor training.

                            Wise.

                            Comment

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