Paralysed man died after Ecuador surgery

[PeteShick]

India, Europe... maybe.
Ecuador... No way José!
WTF? I can't imagine.

Thanks for the heads up though. Sorry it comes at such a priceless expense... Life is precious.
I look forward to regulated treatment in the good ol' USA!
patience...

[MonTesquieu]

He had many bouts of dysreflexia before going to Ecuador. We thought that the doctor knew of this condition. He obviously did not. The doctor told us it was safe. I emailed the doctor a year after my son died and pretended to be a potential patient. The doctor told me there were no complications, no icu admissions and no deaths. SO WHAT ABOUT MY SON. He was completely omitted from his reply. I want to make people aware of the dangers. If my son had known of previous complications he would never had gone there. I just want to prevent the same thing happening to someone else and their family. So dont do it unless you want your family to be told that you have passed away and then an hour later to tell you they are alive again, or to be taken away in a critical condition in the back of a campervan for a brain scan, or taken away after your death on the back of a pick up truck for your family to see, or not allowed to see you in the undertakers because conditions were too bad, or owe 10,000 dollars for a few days in icu and fear for your own life or even not embalm you correctly. These are just a few of the horrendous things I had to deal with on my own in a foreign country!! My family will never be the same again!!

I'm sorry chickies!!!

[LindaT]

Very tragic. Condolences chickies.

[Wise Young]

Deaths from transplantations of cells into the spinal cord are very rare. To my knowledge, the largest series of spinal cord transplants was done by Dr. Hungyun Huang. I believe that he has done over a 650 transplants. I believe that mortality in series was 3 patients from causes unrelated to the surgery. This is a relatively low mortality rate considering the population that was being operated on. The laminectomy and the transplantation procedure does not appear to be dangerous.

I have not heard of any patient dying from intracranial hypertension after an operation to transplant the spinal cord. The cause of intracranial hypertension was not specified. When did it occur? Did the doctors observe papilledema? In general, the opposite should occur, i.e. intracranial hypotension occurs when the surgery takes too long and too much cerebrospinal fluid has drained out. This can cause the ventricles to collapse, blood vessels to break, and development of subarachnoid hemorrhage.

I am very sorry that it happened.

Wise.



References

1. Huang H, Chen L, Xi H, Wang Q, Zhang J, Liu Y and Zhang F (2009). [Olfactory ensheathing cells transplantation for central nervous system diseases in 1,255 patients]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi 23: 14-20. Beijing Hongtianji Neuroscience Academy, Beijing, 100144, P.R. China. hongyunh@gmail.com. OBJECTIVE: To analyze the therapeutic effect of olfactory ensheathing cells (OECs) transplantation for central nervous system diseases. METHODS: Between November 2001 and January 2008, 1,255 participants with central nervous system diseases were enrolled in this clinical study for fetal OECs transplantation. There were 928 males and 327 females aged 1.2-87 (mean 40) years. The course of disease was (4.52 +/- 4.67) years. Among them, 656 participants suffered from chronic spinal cord injury (SCI), 457 amyotrophic lateral sclerosis (ALS), 68 cerebral palsy (CP), 20 multiple sclerosis (MS), 11 the sequelae of stoke, 10 ataxia, and 33 residual diseases. The participants came from 71 countries or regions. Accidentally abortional fetal olfactory bulbs were donated voluntarily and were cultured for 2 weeks, then were transplanted. RESULTS: One thousand one hundred and twenty-eight cases were followed up for 2-8 weeks (mean 4 weeks) to obtain integrated data. Among them, the neurological functional amelioration was noticed in 994 participants with the overall short-term improvement rate of 88.12%. Seventy-six patients experienced the various perioperative complications with the incidence rate of 6.74%. One hundred and twenty patients with SCI received over 1 year follow-up. And according to ASIA assessment, motor scores increased from (39.82 +/- 20.25) to (44.55 +/- 18.99) points, light touch scores from (51.56 +/- 25.89) to (59.81 +/- 27.72) points, pain scores from (50.36 +/- 27.44) to (57.09 +/- 28.51) points for foreign patients (P < 0.05); motor scores increased from (40.52 +/- 20.80) to (46.45 +/- 20.35) points, light touch scores from (55.64 +/- 26.32) to (68.64 +/- 25.89) points, pain scores from (57.05 +/- 26.00) to (66.13 +/- 24.29) points for good rehabilitation Chinese patients (overall P < 0.05); motor scores from (37.03 +/- 18.52) to (38.03 +/- 18.50 points (P < 0.05), light touch scores from (45.88 +/- 22.56) to (46.63 +/- 23.09) points (P > 0.05), pain scores from (45.25 +/- 23.68) to (45.28 +/- 23.63) points (P > 0.05) for poor rehabilitation Chinese patients. Compared foreign patients and good rehabilitation Chinese patients with poor rehabilitation Chinese patients, difference in score change was remarkable (P < 0.05). One hundred and six cases of ALS, 32 CP, 8 MS, 7 ataxia, and 2 stroke sequelae were followed up for 3-48, 3-36, 2-20, 7-17, 6 and 24 months, One hundred and six cases of respectively. Majority of them (113/155, 72.9%) were benefited from OECs transplantation. CONCLUSION: OECs transplantation into brain and spinal cord is feasible and safe . The therapeutic strategy is valuable treatment for such central nervous system diseases such as chronic SCI, ALS, CP and stroke sequelae and can improve the patients' neurological functions and/or decrease the progressive deterioration.

[Wise Young]

I should add that while doing a laminectomy and transplanting cells into the spinal cord has a low mortality rate, several other complications may arise from transplantation of cells into the spinal cord.

First, the injections of the cells into the spinal cord may damage the injection site, depending on the volume of the injectate. We have interviewed surgeons who transplant olfactory ensheathing glia or other cells into the spinal cord and understand that most inject 35-50 µliters into the spinal cord above and below the injury site. We thought that this was too much (since each µliter is about one cubic millimeter of volume. So, in our ChinaSCINet trials, we have systematically looked at 4, 8, and 16 µliters injected into the dorsal root entry zone (DREZ). So far, it seems that 16 µliter injections do not cause any persistent loss of function in the segment above the injury site.

Second, the sterility of the cells is important. One cannot of course sterilize cells by heat or other means before transplantation because anything physical that kills bacteria would kill cells. One can put antibiotics into the culture medium of the cells but, as most people who have had antibiotic resistant urinary tract infection know, antibiotics are not a guarantee of sterility. Antibiotics also don't get rid of viruses. The most important and effective way of ensuring sterility is to get the cells from a sterile source and practice very careful and thorough sterile procedures in all the cell handling procedures. Most fly-by-night clinics don't follow such procedures and the likelihood of contamination is high. One does not want contaminated cells to be injected into the spinal cord.

Third, pluripotent cells can produce tumors. This is the reason why most investigators pre-differentiate the cells before they transplant the cells into the spinal cord. In general, the cells that are most likely to produce teratomas (stem cell tumors) are embryonic stem cells and induced pluripotent stem cells that have not been pre-differentiated. Once the cells have been differentiated, they are no longer pluripotent. In other words, they cannot make many different kinds of cells. However, even a few non-differentiated cells may survive and produce a teratoma. That is the reason why the FDA went to great lengths to force Geron to show that less than one out of a billion cells were pluripotent, before they were willing to allow them to transplant embryonic stem cells into humans.

In contrast, neonatal and adult stem cells (mesenchymal, bone marrow, umbilical cord blood) require "niches" in tissues before they can make many kinds of cells and therefore are much less likely and have not been reported to produce tumors in the spinal cord. That may be one reason why there have been few or no cases of tumor reports despite thousands of patients who have received bone marrow and umbilical cord blood transplants.

Wise.

[chickies]

Chickies, My condolences also on the unnecessary death of your son. I think your follow up email should warn others to, at the very least, ask for former patients you can talk to as you think about some of these unpublished trials or procedures. The doctor cannot claim confidentiality if you give him your contact info for those former patients to call you. If you do not get any previous patient who will call you collect then that should be the deal breaker.

If any previous patient reads this please contact me 07803 174335 or email at chickies@blueyonder.co.uk. tks