Spinal cord mass arising from neural stem cell therapy

barbara

Pioneer Founding member
Science Blog
7-8-14

A 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: Spine. 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.

The patient was 18 years old when she sustained a fracture dislocation at the 10th and 11th thoracic vertebral level in a motor vehicle accident. Despite surgery to stabilize the spine, the injury rendered the patient paraplegic. Three years later, in the hopes of regaining sensory and motor function in her lower limbs, the young woman underwent additional surgery at an institution outside the United States, during which an autograft of olfactory mucosa was placed in her spinal canal at the site of injury. Eight years after the experimental therapy, the woman sought medical care for mid- to lower-back pain at the University of Iowa Hospitals and Clinics. On neurological examination, she showed no sign of clinical improvement from the olfactory mucosal cell implantation, and imaging studies revealed a mass in her spinal canal pressing against the spinal cord. This mass was the source of the patient’s pain.

Following surgery to remove the symptom-producing mass at the University of Iowa, a tissue analysis showed that the mass contained a small proportion of nonfunctional tiny nerve branches, whose appearance led the authors to suspect the nerve branches developed from transplanted neural stem-like cells. The tissue analysis also demonstrated that most of the mass consisted of multiple cysts lined with respiratory mucosa and underlying submucosal glands and goblet cells. Abundant mucus-like material was also found in the mass. Accumulation of this material over time produced the patient’s symptoms.

The authors describe various ways of extracting olfactory mucosa cells for implantation. In this particular case, a portion of olfactory mucosa was transplanted; in other trials, olfactory ensheathing cells have been extracted from olfactory mucosa and purified prior to implantation. The authors suggest that the choice of bulk olfactory mucosa rather than purified olfactory ensheathing cells or stem cells as an autograft may lead to the development of a mass containing functional respiratory mucosal cells.


The authors point out that a rare case of spinal cord complication such as this should not discourage stem cell research and/or the transition of promising research to the clinical setting.
However, the authors indicate the need for a better understanding of what can occur and urge clinicians to extend the monitoring period in patients treated with neural stem cell therapy for many years in case an adverse event such as this should arise. In summarizing the take-away message of the paper, Dr. Brian Dlouhy stated: “Exhaustive research on how transplanted cells divide, differentiate, and organize in animal models of disease, especially spinal cord injury, is critical to providing safe and effective treatments in humans.”
 

Claire

New member
Makes absolutely no sense to me to perform such a protocol!

Rare examples such as this are the exact reason why the FDA needs to stop stifling the use of auto SCs in the US. Only I will receive my SCs; they will not be distributed to the masses -- there's no public health risk involved that merits FDA involvement. Bringing a new drug to market costs billions and takes decades. Even if a doctor could hypothetically do that for each patient, would the patient still be alive if/when the personalized “drug” is approved? Auto SCs are the safest, most effective option for many patients, suffering from a variety of conditions, but our own SCs can't be patented unless they are reformulated into outrageously expensive pharmaceuticals. So, we are condemned to suffer and die a "safe, FDA approved death" or be forced to travel off-shore. These new regulations drive patients off-shore, at great cost and physical pain; this is what places patients at far greater risk of shady practitioners, and this excludes those patients who are too impoverished or debilitated to have the opportunity to avail of these treatments.

Hearts, lungs, kidneys, corneas, skin and other organs are transplanted in the U.S. every day, without FDA drug approval. If heart transplants, gastric bypasses, or liposuctions had been held to these new regulatory standards, they would never have become standard practices of medicine. Blood transfusions and IVF are not held to such regulatory standards. Many hospitals would fail this level of regulation.

The use of autologous stem cells is the medical breakthrough of our times. Unfortunately, the status quo has too much invested in the prevention of this breakthrough.

Regulating one’s own stem cells in the same manner as mass-produced pharmaceuticals places undue burdens on physicians and stifles medical innovation. Allowing patients to use autologous stem cells will revolutionize the practice of medicine in this country. Our own cells provide doctors with the potential to cure or ameliorate many chronic diseases, illnesses and injuries in a safer, less invasive and more cost effective manner. The potential overall health care savings are enormous and the societal benefits incalculable. Imagine disabled people returning to the workforce; imagine fatal disorders becoming temporary problems! Imagine debilitating, chronic pain becoming a warning that something needs to be fixed, rather than a life sentence!
 

barbara

Pioneer Founding member
It was indeed a rare occurrence and the mass was not malignant, but you can be sure the fear mongers are using this as an example of, "We told you that stem cell treatment was risky".

The protocol in question was very strange indeed. The authors of the case report caution that physicians should be vigilant in their follow-up of patients who undergo stem cell interventions. Isn't this true of millions of patients who undergo treatment for cancer, cardiac disease, lung disease, etc. as well as patients with chronic diseases. Most patients continue to visit their doctors on an ongoing basis. I surely hope that there isn't going to be some kind of new demand for patients in stem cell clinical trials to be followed for 10 years+ because of this very rare occurrence.
 

Claire

New member
Via Falk Heinrichsohn

Business Consultant & Partner at Aristoloft Ltd, EUROPE

Unfortunately it is true that this “sensational info” is often used wrongly. In this case, we have to be aware that the experimental treatment had been started and carried out in 2006. Stem cell Know how since that time exploded exponentially, but even though it was an early attempt of stem cell treatment, please note this relatively "unpleasant side effect" was after the source of pain was understood, quickly removed without further problems. A side effect which is really minor compared with about 573111 reported SAE in 2011 of FDA approved pharmaceuticals.

Furthermore, when reading “sensational information " it is necessary to dig into background information and look for the small print somewhere in order to really understand what happened…….

In this case background research finds:

“In 2010, the Lisbon researchers published their results of an approved experimental clinical trial using this method on 20 people paralysed at various locations in their spine.

Link: http://nnr.sagepub.com/content/24/1/10

Eleven experienced some recovery of movement or sensation; one person's paralysis got worse, one developed meningitis and four others experienced minor
adverse events……..

....... Jean Peduzzi-Nelson, a stem cell researcher at Wayne State Universityin 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 experiencedimprovement. "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."

In this connection please also see a link of another patient, one, who is not part of the unfortunate "less than one percent":

http://www.leaderu.com/science/stemcelltestimony_dominguez.html

As Stem cell Know How and treatment is advancing, like the computer revolution in the 1990, mainly outside the regulated FDA territory, I, also believe that autologous stem cells from adipose tissues (fat) today probably would be a better option, but this was not that so clear in 2006 when the trial started.
 
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