Hello Steffan, and thanks for your feedback. My following comments are “my opinion” only and should not be construed as medical, legal, or professional advice, nor are they based upon any extensive research of the Drs/entities you have recommended. First, you seemed to question the propriety of the “clinic in Mexico” however, I do not recall disclosing any information about that entity. Mexico, has very high standards, perhaps higher, than the USA when it comes to stem cell therapy at this time. The US FDA does NOT review, regulate or oversee stem cell therapy at the clinical level at this time. The only oversight, to some extent, is at initial ‘harvest” of MSCs long before being sent to the administering physician, according to my research.
In Mexico ONLY a very few Doc, hospitals, etc. are permitted to “harvest” and administer as regulated by COFEPRIS. The Mexican cardiologist we go to has that certification, which he not only showed (pursuant to my contract) but also allowed me to photograph for my own records.
Next, this is AGAIN just my “personal opinion” but according to the link you provided: “clinicaltrials.gov; the administering entity (and sponsor of the trial(s) is NUSTEM, WHICH is a CLINIC in Beverly Hills! Its not conducted at a University per se. Perhaps there is a relationship–as is generally the case with “clinical studies”-- as they are oftentimes funded by government grants to the University that then gives money to the Dr or clinic conducting the “trial”. There really is “no oversight” by a University hospital etc. in fact quite the opposite. The university helps the doc get funded, but the doc is REALLY the expert, not the other way around. Chances are the patient will also go to a clinic…which apparently is NuStems in the BH. So lets not confuse attempt to critique one clinic vs another. As for the “clinicaltrials.gov”, this is NOT a “policing body” that conducts any type of oversight. Any individual or “sponsor”(NuStem) can and/must list in order to get funded. Just because an entity does so, by itself, does not necessarily lend legitimacy to the “trial” being conducted. In fact, there are several ‘renown” docs conducting stem cell ‘trials” ad naseum, using the ‘clinicaltrials.gov” to convince patients that their research is —in fact—legitimate, when reality suggests otherwise. Again, I have researched many organizations offering “trials” in USA and have discovered issues with many.
Third your Drs STEM cell trial/research looks very general (as it states): covering “Autoimmune Diseases; Cardiovascular Disorders; Diabetes Complications; Integumentary Disease; Musculoskeletal Disorders; Neurodegenerative Disorders; Neurologic Disorders; Pulmonary Disorders; Sexual Dysfunction; Urologic Disorders; Viral Illness” THAT is a HUGE list, none of which specifically addresses BVFTD which is my wife’s purported disease. And your docs program gives ONE injection, and then 12 mos of so-called monitoring, and to 5000 patients, with the program ending in 2030! That sounds too little, and the results are too late.
FINALLY, what I have discovered, in my research, that regardless of the Docs credentials, and perhaps their “sincere intent”, they still rely on the EXACT SAME acquisition, process, and distribution system to obtain the stem cells used in their study. Ultimately when a patient shows up, the doc breaks out a little “sealed” bag/vile stamped with “50Million”; 100 M or whatever MSC labeled on the side. The stem cells are NOT harvested on site, but at some far off medical facility THEN cryo-frozen and shipped to/through God knows how many other manipulators. The final administering entity is 100% reliant on “what” is stamped on the side of the vile/bag. The doc then (purportedly) defrost the sample, then —without any verification-- whatsoever proceeds to inject the ‘serum’ into the patient. There is absolutely ZERO confirmation as to the actual “quantity’ of the cells being administered, and MORE IMPORTANTLY how many of those are ACTUALLY ALIVE!!! AND THAT IS CRITICAL! Those MSCs MUST BE LIVE, at injection time, or its all pointless. But unbelievably, I have pushed docs/clinics thru all of this….and they insist/confirm everything is “kosher”, UNTIL I hand them my contract that specifies that they need to verify quantity/viability at the MOMENT of injection. And that’s when they all run like the cockroaches because they CANNOT verify. OR—more pathetic-- I have actually had a couple, after being pinned on this exact issue, retort “it doesn’t matter whether the MSCs are live or dead” , blah blah blah…The fact THEY CAN verify, at the point of administration! there is a computerized “verifier” available exactly for this process, but very few end using clinics invest in the same, or know they REALLY DO NOT want to know.
Again, my comments here are not intended to be directed at NuStem or your Dr who you rely upon in Beverly Hills, Murrietta or wherever, but I spent SIX MONTHS scrutinizing all sorts of Docs, PHds, chiros, clinics etc. and have heard it all.
In Guadalajara, where we go, the “clinic” is actually contained within a very upscale medium sized hospital in a beautiful neighborhood. The administering physician IS a board certified cardiologist as well. His offices host a dozen staff members including 2 other fulltime physicians. They disclosed all the documents related to the DONOR mother; the fact it was cesarean birth umbilical cord, and her medical history. (certain portions were redacted for privacy purposes). The MSCs are likewise cryo-frozen but right there at the same hospital at the administering clinic! At the time of harvest, we are present, to witness, at which point they THEN place a sample into the computerized measuring device that generates a report as to the quantity (total # of SC) and their “viability” (% alive)count right at that time. If all passes my muster, it is then injected into my wife (and myself). They actually FEED live video of the transport of the vile from the testing lab to the hospital room where we are located. Its about a 3 minute walk, but we watch the whole thing! TRY THAT IN THE USA!
So Steffan, perhaps, in the future, you should educate yourself in these matters before you “assume’ there is something amiss with Mexican stem cell therapy? That is NOT to say its all good, in fact, there are shysters, and con men on ALL sides of the borders…as we say in the legal practice: “caveat emptor”.
