Note: There is now a major update to this story published here, which explains a lot of the questions remaining in this blog post.
Seven years ago I returned to Michigan, where I was born and spent the first quarter century of my life, after an absence of more than 20 years. In the interim, I had done my surgical residency and earned my PhD in Cleveland, a surgical oncology fellowship in Chicago, and worked in New Jersey at my first academic job for eight and a half years. Then I was lured back with a job in Detroit. One of the odd things about this return after such a long absence was the culture shock, how much I had forgotten about the Detroit area. One of those things that I had forgotten is just how crazy about hockey Michigan, in particular Detroit (meaning the Detroit metropolitan area), is. Detroiters love their Red Wings—love them. Hockey is ingrained in the suburban culture from a very young age, so much so that many Canadians would feel right at home here. Memories of trying and failing to be halfway decent at street hockey and of not being anywhere good enough a skater even to try real hockey as a teen came flooding back to me. (It didn’t help that back then I was approaching six feet tall and weighed only 135 lbs.; “beanpole” didn’t even begin to describe me back then.) In fact, the “cultural center” of the town where I live consists of—I kid you not—a hockey rink and some classrooms that are used for various community functions. No, really, it’s named the city’s Cultural Center.
So it should be no surprise, given how much Detroiters love hockey in general and their Red Wings in particular that it was big news here in late October when Red Wing legend Gordie Howe at age 86 suffered a debilitating stroke that paralyzed the right side of his body, a condition known as hemiplegia. Understandably, there was an outpouring of good wishes for recovery, coupled with retrospectives of Howe’s stellar hockey career. Indeed, I remember that Howe’s condition sounded bad enough from the tenor of the news reports at the time that it seemed likely that he would not survive. But survive he did, and is apparently recovering slowly, with occasional setbacks, such as a recent hospitalization in early December for a suspected “mini-stroke” that turned out to be dehydration and several much smaller strokes before that. The most recent press report I saw before the announcements I’m going to discuss described Howe as on the upswing again.
Then, on Friday, I saw headlines all over the place that were basically similar to this Detroit Free Press headline, “Gordie Howe underwent stem cell clinical trial in Mexico.” The story consisted largely of a press release from Howe’s family that read:
Following the press coverage of our father’s deteriorating medical condition, the Howe Family was contacted in late November by Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies. McGuigan knew our family as a result of his previous employment with the Detroit Red Wings. Stemedica is a biotechnology company that manufactures allogeneic adult stem cells in its U.S. government licensed, cGMP facility in San Diego, California. Although no relation, Dr. Howe and his brothers Drs. David and Roger are hockey players and big Gordie Howe fans, having grown up in Minnesota. They wished to help our father by generously facilitating Dad’s participation in a stem cell clinical trial at Novastem, a licensed distributor of Stemedica’s products in Mexico.
Novastem (www.novastem.mx) is currently conducting federally licensed and Institutional Review Board approved clinical trials for several medical conditions, including stroke, using Stemedica’s stem cell products. At the time we were contacted, Mr. Hockey had been rapidly declining and was essentially bedridden with little ability to communicate or to eat on his own.
After reviewing the information on Stemedica and Novastem, our family decided to give our father this opportunity. On December 8, Mr. Hockey underwent a two-day, non-surgical treatment at Novastem’s medical facility. The treatment included neural stem cells injected into the spinal canal on Day 1 and mesenchymal stem cells by intravenous infusion on Day 2. His response was truly miraculous. At the end of Day 1 he was walking with minimal effort for the first time since his stroke. By Day 2 he was conversing comfortably with family and staff at the clinic.
On the third day, he walked to his seat on the plane under his own power. By Day 5 he was walking unaided and taking part in helping out with daily household chores. When tested, his ability to name items has gone from less than 25 percent before the procedure to 85 percent today. His physical therapists have been astonished. Although his short-term memory, strength, endurance and coordination have plenty of room for improvement, we are hopeful that he will continue to improve in the months to come.
As a family, we are thrilled that Dad’s quality of life has greatly improved, and his progress has exceeded our greatest expectations. Once again, we cannot emphasize how much you have fueled Mr. Hockey’s recovery and we thank everyone for their continued prayers and support.”
Local news station WDIV picked up the story without even an iota of skepticism:
This report even ends with the anchorman telling the reporter that he hopes the FDA hears about this and gets something going here too, which, as I discovered researching this, reveals an incredible depth of ignorance and shows that not one bit of fact checking went into this story. As you will see, there are FDA-approved clinical trials of Stemedica’s treatments currently under way; so the FDA already knows.
Then on Saturday there appeared this report broadcast on ESPN in which Howe’s sister is quoted as saying that he could “come tap dancing off the plane” in a month and a half after his son Murray, a radiologist in the Toledo area, announced that Howe was going to be the guest of honor at the Kinsman Celebrity Dinner along with hockey great Wayne Gretzky in Saskatoon, where Howe spent his childhood, on February 6:
One also notes that, according to the reports listed above:
Cummine said she talked to Howe’s son Murray, a doctor, a couple of days ago and he told her the longtime NHLer is progressing nicely.
“He’s up walking a few steps, and he’s trying to put words together to form a sentence,” Cummine said. “Murray’s exact words were ‘he’s kicking ass.'”
This sounds a lot different than the press release. Naturally, my skeptical antennae, which had started twitching reading the first story, started twitching even harder. You’ll see why shortly, although hearing about a Mexican stem cell clinic ought to be enough to send up a thousand red flags. What is the real story? It’s been hard to find out, and I still don’t know for sure that I have managed it.
Stem cell treatments: Hype versus science
We at Science-Based Medicine (SBM) have written about dubious stem cell treatments on many occasions. Stem cells, of course, are cutting edge science. The problem, of course, is that that cutting edge science, with very few exceptions, has not yet been translated into safe and effective treatments for the conditions that it has promise to treat. Enter the quacks, who make what I’ve referred to as magical claims for stem cells. Are Stemedica and Novastem like this? Let’s find out. After all, just because Novastem is in Mexico does not necessarily mean it’s one of these dubious stem cell hucksters, although a first glance at the Novastem website most definitely did not allay my suspicions.
There are two types of stem cells, embryonic stem cells and adult stem cells. The first (and potentially most useful for the widest variety of conditions) are pluripotent, which means that, given the right signals, they are able to differentiate into all derivatives of the three primary germ layers in the embryo: ectoderm, endoderm and mesoderm. In other words, they are able to become virtually any kind of cell. You can easily see why embryonic stem cells are attractive as a treatment: In theory, they could be used to replace or repair any tissue that requires it, if only they could be targeted to where they are needed and the correct signals could be deduced to induce them to differentiate into the needed cell type(s). These are enormous challenges. Add to that the religious objections to these cells, given that it is necessary to create pre-implantation embryos to isolate them and, in so doing, destroy these embryos, and the challenges are even greater, particularly in the US where restrictions on embryonic stem cell generation and use are more strict than in other developed countries.
The second kind of stem cells is known as adult stem cells. Adult stem cells are undifferentiated cells that remain in children and adults and can proliferate to replenish dying cells and regenerate damaged tissues. They are also known as somatic stem cells. Their defining properties include, as for embryonic stem cells, self-renewal (the ability to divide indefinitely while remaining undifferentiated) and multipotency, the ability to differentiate into several cell types. In contrast to embryonic stem cells, though, adult stem cells are limited in the types of cells into which they can regenerate. For example, there are hematopoietic stem cells, which can give rise to all the types of blood cells: red blood cells, B lymphocytes, T lymphocytes, natural killer cells, neutrophils, basophils, eosinophils, monocytes, and macrophages; mesenchymal stem cells, which can give rise to a variety of cell types: bone cells (osteoblasts and osteocytes), cartilage cells (chondrocytes), fat cells (adipocytes), and stromal cells that support blood formation; and neural stem cells, which are found in the brain and can produce the brain’s three major cell types: nerve cells (neurons) and two categories of non-neuronal cells—astrocytes and oligodendrocytes.
Finally, there is a cell type known as an induced pluripotent stem cell (iPSC), which are adult stem cells that have been genetically manipulated to express genes and factors important for maintaining the defining properties of embryonic stem cells, but it is not yet known whether these cells can be used as embryonic stem cells and their uses now, for the most part, consist of in vitro studies and show potential usefulness in transplantation medicine. One problem with iPSCs is that viral vectors are needed to introduce the genes that “dedifferentiate” the adult stem cells, making their use in humans as yet problematic.
In any event, there remain many problems to be overcome, such as how to target the cells, how to induce them to differentiate properly, and how to prevent them from becoming cancers. Thus far, in general, most attempted clinical uses of stem cells involve the isolation of these cells from either the bone marrow or blood (or sometimes from adipose tissue). My basic opinion is that, outside of hematopoietic malignancies, for which bone marrow ablation and stem cell transplantation have been a standard of care for many years, most adult stem cell applications are not ready for prime time yet. It wouldn’t surprise me if we see some treatments clearing that hurdle in the next few years, but most of these therapies are still in either preclinical or phase I testing, with few having yet shown sufficient evidence of efficacy and safety to achieve FDA approval.
In the meantime, Steve has cautioned readers to be wary of stem cell pseudoscience, emphasized the need for transparency, and decried stem cell tourism. Jann Bellamy has commented on how regulation and law have not yet caught up with stem cell science (and pseudoscience). I myself have noted how prevalent stem cell quackery is throughout the world, including China, Ukraine, Panama, Italy, and, yes, Mexico. Given the track record of various companies offering stem cell treatments with inflated claims, my viewpoint when I encountered stem cell treatments outside the confines of reputable academic institutions tends to be one of extreme skepticism, a skepticism that usually is well-justified.
Is such skepticism justified for Stemedica and Novastem? Let’s find out.
The stem cell clinical trial
The first thing I noticed when I perused the Novastem and Stemedica websites is a distinct—shall we say?—difference in the marketing. The Novastem website declares Novastem a “world leader in regenerative medicine and stem cell therapy” and touts as its list of experts; doctors who to me appear to have no special expertise in stem cells or stem cell medicine. There are internists, a urologist, an otolaryngologist, general surgeons, a pulmonologist, a neurologist, and an orthopedic surgeon, but a perusal of their qualifications (when listed) through Google Translate (their CVs are in Spanish) reveals little that impresses me that they have the expertise to carry out legitimate clinical trials of stem cells. Seriously, their CVs are completely underwhelming. Heck, I could make a strong argument that I’m more qualified than any of them to be doing stem cell research!
Then, Novastem describes its treatment:
At Clínica Santa Clarita, we provide the highest level of personal attention to make your experience both convenient and pleasant. Our concierge service will not only help you plan your visit, we will supply luxury, personalized, private transportation locally or to/from San Diego. Our medical clinic is less than five minutes from San Diego, and the new medical line at the border expedites return access. In addition, we can provide assistance with hotel accommodations in San Diego and medical travel insurance, if desired.
Upon arrival at Clínica Santa Clarita, you will be examined by a Novastem specialist who will discuss your medical history and your expectations. Together, you will review the information packet and sign an informed consent form.
Meanwhile, the stem cells from Stemedica, maintained in a state of cryopreservation, are being prepared for therapy and undergoing a final panel of tests to ensure their quality and viability. Prior to your arrival, Novastem does the testing at its facility and verified by a third party lab.
Then, comfortably seated and overseen by our skilled staff of physicians and clinicians, you will receive intravenous delivery of these stem cells. The process is painless and takes less than four hours. Following your therapy, we will transport you back to your accommodations.
So let’s see. The stem cells are produced at Stemedica, which is strategically located in San Diego, shipped across the border from San Diego to Tijuana, then used at Clínica Santa Clarita, which is apparently run by Novastem. They’re given to patients, even though they are not yet FDA approved, with the claim that they can treat “heart attack, stroke and traumatic brain injury,” after which:
In the weeks and months following your treatment, Novastem will maintain contact with your physician to compile data regarding the efficacy of stem cell therapy as it relates to your condition. This data will be verified by a third party Contract Research Organization (CRO), to assure validity.
So, basically, Novastem appears to be providing stem cells manufactured by Stemedical to pretty much anyone with the ability to pay. The closest it appears to be coming to doing a clinical trial is to keep in touch with the primary care physicians of patients treated at its Clínica Santa Clarita. In other words, Novastem appears to have many of the attributes of a quack clinic in Tijuana.
Now let’s look at Stemedica. This company’s web page boasts to its patents about using multiple stem cell lines to treat ischemic stroke and for a cellular scaffold enhanced by stem cell factors. It also has a link to its clinical trials (more on that later) and advertises three different stem cell product lines that have obtained investigative new drug (IND) designations from the FDA, as well as its manufacturing process, which includes a cGMP (Current Good Manufacturing Practice) facility as approved by the State Department of Health and Human Services, Food and Drug Branch. In other words, unlike Novastem, which gives every impression of being a quack stem cell clinic based on its website and marketing materials (not to mention its location in Tijuana), Stemedica does not look like a stem cell quackery clinic. Rather, it gives every appearance of being a legitimate biotechnology company.
It also touts its subsidiaries, such as StemCutis, which is described as producing stem cell-based products to treat dermatological diseases and improve the appearance of patients’ skin due to compromised skin, diabetic ulcers, hair loss, burns and hypertrophic, hypotrophic and keloid scar, and CardioCell, which is described as running clinical trials using stem cells to develop highly effective, “off-the-shelf” therapeutic products for cardiovascular indication. To me, StemCutis looks to be angling to get into the beauty and antiaging market, selling products “consisting of stem cell growth factor-based compounds with a moisturizing skin toner and an elasticity-enhancing, anti-wrinkle cream. For the maximum preservation of the stem cell factors, the factors are enclosed in sugar crystal and sterilized.” Then there’s hair restoration therapy, based on factors expressed by Ischemia-Tolerant Mesenchymal Stem Cells (itMSCs). It turns out that itMSCs are a newer wrinkle in stem cell treatment, the idea being that stem cells will do better if they undergo a preconditioning procedure that sets them into a primed state before they encounter the harsh microenvironment of hypoxia/ischemia and elevated levels of injurious factors in areas like dying heart muscle or dead brain tissue.
Then, of course, there is a clinical trial using stem cells for ischemic stroke (ClinicalTrials.gov identifier NCT01297413), “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke.” Stemedica’s collaborators include the University of California, San Diego, Mercy Gilbert Medical Center at AZ, and Chandler Regional Medical Center at Chandler AZ. Interesting. There’s no mention of Novastem, is there? In any case, it’s not unreasonable to think that this is probably the clinical trial to which the press release was referring, because there is currently no other ongoing clinical trial for ischemic stroke run by Stemedica and no trial listed by Novastem at all.
But what about Gordie Howe?
Now that we know the background, we can take a closer look at Gordie Howe’s case. The description of his recovery has been highly variable, but we know from several news reports that Howe had been improving. For example, right after his stroke, Howe appeared to be getting rapidly worse (which is not uncommon due to the inflammatory reaction that occurs around the dead brain tissue leading to edema, or swelling, of the surrounding brain tissue, with further neurologic compromise). Then, nine days after his stroke, he was reportedly getting much better. Indeed, he had even been reported to have had great improvement in his speech and had been able to walk with the assistance of a walker. Two weeks later, on November 20, Howe was reported to have had a major setback:
Hockey legend Gordie Howe has shown minor improvements, even as he remains largely quiet and immobile.
His son, Mark Howe, told the Free Press today that Gordie Howe, “isn’t in so much pain any more. No walking or speech, but at least he’s out of the bed.”
After showing some improvement, Gordie Howe’s health again appeared dire last weekend. An epidural has helped reduce the pain, and Mark Howe said the family got Gordie Howe “to a living room chair” two days in a row. “A lot of work to do, but at least we got him out of bed,” he said.
As of Thursday afternoon, he had been off pain medication for 54 hours, and “his blood pressure is under control,” Mark Howe said. “”He’s eating again, so his quality of life has improved, for now. We take each day as it comes, and are just happy he isn’t in so much pain any more.”
Then, as mentioned above, in early December Howe was hospitalized again because he was unresponsive for 30 minutes and his family had feared he had had another stroke. It turned out not to be the case; fortunately, he was just dehydrated.
Then, last Thursday, the day before the family issued a press release describing Howe’s treatment with stem cells, there was a report in the Detroit Free Press that described his health thusly:
Howe now has enough strength to be somewhat mobile, a stark – and much welcome – late-December development after the month began with what his children feared was another serious stroke.
Son Mark Howe told the Free Press on Thursday that his father isn’t so much able to walk, rather that “it’s more of a shuffle, but he is making his way around under his own power.”
Now let’s compare this to what the family’s press release said. On December 8, apparently, Howe was given Stemedica’s stem cell treatment at Novastem, which means that he must have been taken to Tijuana. I can’t help but note at this point that Novastem is not one of the collaborating institutions listed on the ClinicalTrials.gov entry for Stemedica’s clinical trial for stroke. Specifically, there are only two sites offering the trial: UCSD’s Department of Neurological Surgery, where the principal investigator is Michael L. Levy, MD, FACS; and Mercy Gilbert and Chandler Medical Center in Gilbert, AZ, where the PI is Nabil Dib, MD, MSc, FACC. Although it makes sense that a neurosurgeon could be a PI for a trial like this, it is a little strange given that most neurosurgeons don’t take care of ischemic stroke patients who are not candidates for an operation to remove blockages of cerebral blood flow, like carotid endarterectomy, and pediatric neurosurgeons virtually never take care of your basic run-of-the-mill adult ischemic stroke. On the other hand, Dr. Levy’s expertise is listed as studying the cerebral vasculature so I have no problem with him as the PI of such a study. I do, however, find it rather odd that the PI at the other site is a cardiologist and not a neurologist or neurosurgeon.
According to the family’s press release, at the end of Day 1 he was walking with minimal effort for the first time since his stroke. That would be December 9. By Day 2 (December 10), he was conversing comfortably with family and staff at the clinic. On the third day (December 11), he walked to his seat on the plane under his own power. By Day 5 (December 13) he was reportedly walking unaided and taking part in helping out with daily household chores, and his cognitive skills had improved markedly.
Unfortunately, this press release does not jibe with contemporaneous reports about Howe’s condition. For example, on December 13 (that would be day 5 in the press release), the Detroit News reported that, after getting worse, Howe was getting better again:
“Both of my brothers have been down in Texas for a couple of weeks, now, and I’m getting some positive feedback,” said Howe, the Red Wings’ chief pro scout, who like his father played for the Wings and is a member of the Hockey Hall of Fame.
“He had his stroke, and he was showing signs of getting better for a couple of weeks. And then, he’s been going downhill for about a month.”
Howe suffered a setback recently, but it was diagnosed as dehydration, and he was released from a hospital after what turned out to be a brief stay.
“Since we got him out of the hospital and got him back home, he’s been eating better and drinking better,” his son said. “He’s been wanting to do his therapy and stuff, again
“So, I’m getting a lot of positive signs, and that’s music to my ears, and I’m excited about it.”
That sounds promising, but nowhere near as seemingly miraculous as the description in the press release.
In the aforementioned report published on December 18 in Detroit Free Press in which Howe was described as “somewhat mobile” and able to shuffle more than walk, it was prominently mentioned that Howe had improved markedly after having arrived home to be in familiar surroundings after his hospitalization. (Howe also has significant dementia, most likely due to his strokes, and it is well known that patients with dementia do worse when removed from familiar surroundings.) In any case, however you want to slice it, let’s just say that there is a serious disconnect between the Free Press report dated December 18 and the press release dated December 19 in the description of Howe’s recovery. The press release makes it sound as if he’s almost back to normal. The other reports sound more like the sort of progress that we might expect to see in an 86 year old less than two months after a major stroke.
These conflicting stories make me wonder if there’s some sort of schism in the family, given that the press release was described by the Free Press as a “statement further detailing the improvements the Detroit Red Wings legend has made over the past few weeks” in contrast to the statement by Gordie Howe’s son Mark that his father was just “shuffling,” as if it were meant to counter Mark Howe’s description of his father’s progress. Of course, that doesn’t change the contemporaneous reports that describe much less improvement.
Be that as it may, what about the clinical trial itself? As the ClinicalTrials.gov entry describes, it’s a phase I/II trial, which basically means that it’s an attempt to do more than just a phase I trial. Recall that phase I trials primarily assess toxicity in an effort to find the best dose to use in phase II and III trials. In this case, the primary measurement outcome is safety during the 12 month study period as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations. Secondary outcomes include:
- National Institutes of Health Stroke Scale Score at 1, 3, 6, 9, 12 months post-treatment
- Mini Mental Status Exam score at 1, 3, 6, 9, 12 months post-treatment.
- Barthel Index Score at 1, 3, 6, 9, 12 months post-treatment.
- Geriatric Depression Scale Score at 1, 3, 6, 9, 12 months post-treatment.
The trial is not randomized; basically, everyone gets stem cells, with the treatment described as “one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells” given intravenously. Note that this is different from what is described in the press release, which includes administration of stem cells into the cerebrospinal fluid on day 1 and an infusion of stem cells intravenously on day 2. In other words, either Howe was not part of this clinical trial, or there was a massive protocol violation. Moreover, given that he received his stem cell injection at Novastem, which is not one of the approved sites, either he couldn’t have been in the clinical trial or there was an exemption granted by the FDA, the latter of which seems highly unlikely.
I think Howe wasn’t on this clinical trial. Moreover, I think he was shunted to Mexico because he wasn’t eligible for this trial. Let’s look at its inclusion criteria:
- Clinical diagnosis of ischemic stroke for longer than 6 months
- Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
- No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
- NIHSS score between 6-20
- Life expectancy greater than 12 months
- Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke
Gordie Howe had his big stroke only two months ago. True, it was suggested that he had had some “mini-strokes” before, but “mini-strokes” usually mean transient ischemic attacks, in which there is a temporary compromise of blood flow to parts of the brain, from which the patient recovers completely. Other reports have him suffering a series of strokes since summer, with the big one in late October. In either case, it really appears that Gordie Howe was not eligible for this clinical trial. His major stroke occurred less than two months ago, and, even if you accept that his first stroke was during the summer sometime, by many accounts, Howe had been slowly improving ever since, except the two setbacks, one in November and one in December, that I discussed above. Either way, even if he could somehow be squeezed in as having had his first stroke six months before, he clearly does not meet the inclusion criterion that demands no sign of neurologic improvement over the last two months.
It needs to be emphasized right here that there are valid reasons for these inclusion criteria. Stroke patients, particularly patients who suffered a major stroke, often wax and wane in the first six months. More importantly, particularly with good rehabilitation, they generally tend to improve over the first several months of their post-stroke course. Eventually, they reach an equilibrium, after which no further dramatic improvement occurs because there are no further areas of neurons that were damaged but not dead to recover and no further remodeling of neural pathways that can occur to mitigate some of the damage. That’s why testing something like Stemedica’s stem cell therapy before the patient has reached that plateau of neurologic stability can falsely make it seem as though the therapy worked when in fact all that was being observed was normal improvement that just happened to correlate with the treatment. It’s also why single patient anecdotes say little and why randomized trials will be needed to determine if Stemedica’s treatment can actually improve neurologic function after major strokes.
All of this is why I conclude that Gordie Howe’s story is not a good reason to believe that Stemedica’s stem cell treatment for ischemic stroke is why Howe has had what is described as a seemingly-miraculous recovery. In fact, given the conflicting stories contemporaneous with Howe’s treatment that were published before this press release, I believe there’s good reason to question whether Howe has actually even made such a seemingly miraculous recovery right after the stem cell treatments. Given that all I can know about Howe’s progress comes from news stories and reports that heavily rely on accounts by various family members, I cannot know for sure what the real status is. Certainly, I’m not likely ever to have access to Howe’s medical records, and his physicians can’t talk to the press unless given permission by Howe himself or, if Howe’s dementia is sufficiently advanced that he is no longer competent to make such decisions, by Howe’s family.
So what’s the deal with Stemedica and Novastem?
There are many disturbing elements to this story, not the least of which is how eager Dr. Maynard Howe and Dave McGuigan of Stemedica Cell Technologies were to glom onto Gordie Howe in order to promote their treatment and their clinical trial. First of all, they must have known that Howe is currently not a candidate for Stemedica’s trial, given that his stroke happened less than six months ago and his neurologic condition has clearly not yet stabilized. So what did they do instead? By the family’s account in the press release, they facilitated Howe’s “participation in a stem cell clinical trial at Novastem, a licensed distributor of Stemedica’s products in Mexico.”
Try as I might, I couldn’t find a description of Novastem’s alleged clinical trial of Stemedica’s products for ischemic stroke. There is no entry in ClinicalTrials.gov, which is probably not surprising if Novastem’s trial is all in Mexico. Next, I Googled “Novastem” and “clinical trial,” but all I could find were mainly articles about Gordie Howe’s stroke in which his family’s press release is cited, and articles with the words “nova” and stem” in them that link to a NOVA story on stem cells. More importantly, all I could find on the Novastem website about clinical trials was this:
…however, with the right steps in place Novastem at Clínica Santa Clarita is licensed by federal authorities. We specialize in stem cell research and therapy, and the stem cells we import from Stemedica, a biopharmaceutical company based in San Diego, have been produced under a license from the California Food and Drug Branch. The stem cells are delivered to each patient via intravenous infusion with no known side effects.
Then there’s this:
At Clínica Santa Clarita, Novastem and its U.S. partner, Stemedica, believe that MSC-based stem cell therapy is advanced enough to offer as a viable and ethical option for individuals seeking solutions to life-altering ailments that have not responded to traditional treatment. Licensing agents in Mexico agree. And we routinely treat patients of all ages and from all countries, including Canada, the U.S., England and Australia.
In other words, unlike the case with Stemedica, there appears to be nothing that we would consider a real clinical trial going on at Novastem. What’s depressing is that Stemedica might actually be making stem cell products with the potential to do some good, given that the FDA has approved legitimate clinical trials, such as the aforementioned phase I/II trial of stem cells for ischemic stroke, a phase IIa randomized trial for non-ischemic heart failure, a phase IIa randomized study of allogeneic mesenchymal bone marrow stem cells to treat myocardial infarction, and a phase I/II study of bone marrow-derived stem cells to treat cutaneous photoaging. This is good. This is how a company should find out whether the new treatments it’s developed work or not.
So why is Stemedica supplying its stem cell products to Novastem to treat pretty much anyone the doctors down there want to treat? I don’t know, but the likely explanations I come up with when I think about this question are not flattering to Stemedica, particularly coupled with this blatant publicity ploy in which Stemedica “facilitated” getting Gordie Howe’s family to take him to Novastem, even though he was clearly not eligible for Stemedica’s legitimate phase I/II clinical trial offered in the U.S. It’s not mentioned whether Gordie Howe’s family had to pay for the privilege, but certainly other patients treated at Novastem do—cash on the barrelhead. Or wire transfer. No checks or credit cards, apparently. Did Novastem treat Gordie Howe for free in return for the publicity? Does Stemedica “look the other way” with respect to Novastem’s dubious practices because it needs the money to keep its company going? Why is it apparently having its customer adminster stem cells to patients outside of the US and outside of anything resembling a real clinical trials? Inquiring minds want to know. Sadly, the press was not particularly inquiring when it reported this story, failing, as it did, to note that this was almost certainly not a real clinical trial and that it’s impossible to tell whether the stem cell treatment actually did anything from what we know. That’s leaving aside how unethical it looks for Stemedica executives to have contacted Howe’s family and shunted him to a Mexican clinic using its stem cells.
Even though I hope Gordie Howe does well, well enough to appear at the Kinsman Dinner in less than seven weeks, and even hope that I was wrong and the stem cell treatment he received actually did some good, right now I have no choice based on what I know to doubt very strongly that Novastem’s treatment did anything for him. As for the press’s utter credulity and lack of fact checking and investigation, I can only hope that that changes in the future. As of now, Stemedica and Novastem just got a huge shot of free and favorable publicity, thanks to credulous press reports that did no more than regurgitate the press release. If anyone does any real reporting on this story, I doubt the publicity will be as good.
ADDENDUM: In retrospect, when I wrote this post yesterday I might have given Stemedica too much of the benefit of the doubt. I’ve since learned that teaming up with dubious non-US stem cell clinics like Novastem to distribute its product outside of legitimate clinical trials appears to have been part of its MO for quite some time now:
- Trading on hope
- Stemedica thrives on neglect
- Monitoring and Regulating Offshore Stem Cell Clinics
- Quack You! Medical Tourism and Stem Cells
ADDENDUM #2, December 23, 2014: Here is a stem cell researcher’s take on the Gordie Howe case. Let’s just say that he’s as skeptical as I am.