The stem cell company Stemedica along with Mexican partner Novastem conducted a stem cell intervention on hockey legend Gordie Howe, who had suffered strokes in 2014. This situation has sparked a lot of discussion and media attention including a recent interview with Stemedica leadership on the Keith Olbermann show on ESPN.
For balance and fairness I invited Stemedica to comment on this situation and below I have posted their January 23 response verbatim:
“As part of ipscell.com’s coverage of Gordie Howe’s participation in a stem cell trial for stroke, we believe several key facts have been missed, and certain circumstances have been misrepresented. Thank you for allowing us to set the record straight.
* Gordie was an accepted participant in a government authorized clinical trial in Mexico. That clinical trial meets all of their government’s requirements including: IRB/Ethics Committee oversight of an approved clinical trial protocol and the conduct of clinical trials; adherence to inclusion/exclusion criteria of the protocol; signing an informed consent; reporting adverse events; and, collecting other clinical data as outlined in the protocol.
* Gordie Howe, (as his family reported to the media), was not eligible for enrollment in Stemedica’s US-based stroke clinical trial due to certain inclusion criteria. The family did apply for enrollment in the stroke trial at Novastem’s Clinica Santa Clarita where the inclusion criteria are different. Stemedica’s stroke trial in the U.S. has a six-month wait period post-stroke and the family was concerned that Gordie might not live for six more months. The fact that the wait time for participation is different between these two clinical trials was the determining factor the family used in choosing the Novastem clinical trial at Clinica Santa Clarita.
* As a participant of a clinical trial, Gordie Howe’s involvement in that trial was confidential. There was no effort by Stemedica or our Geographic Distribution Partner in Mexico, Novastem, to breach that confidentiality. It was Gordie’s family, under constant requests from media and fans to know more about Gordie’s health, that they, (the Gordie Howe family), made a public pronouncement. Since then, we have professionally responded to approaches from the media after receiving a request from the Howe family to do so.
* It’s important to note that not all stem cells are manufactured the same way. Therefore, different stem cells manufactured by different companies exhibit different properties. There is still an honest and open debate about what role autologous adult stem cells, allogeneic adult stem cells, iPS cells and, embryonic stem cells are going to play in developing new medications for the treatment of various conditions in the future. The efficacy of adult allogeneic stem cells – as is the case with all stem cells – can only be evaluated based on data collected through well run and government-approved clinical trials.
* As was the case in Keith Olbermann’s interview with Stemedica’s Vice Chair/CEO, Dr. Maynard Howe, on January 21, 2015, whenever Stemedica has an opportunity to interact with the media, we make best efforts with that audience to emphasize the need to be cautious about: treatments which are unregulated; use of stem cells of unknown origin; and/or, promises or guarantees of positive outcomes. We work diligently to adhere to all laws, professional practices, and ethical standards. We encourage patients, like Gordie Howe and his family, to demand documentation of the clinical trial’s compliance with these guidelines before committing to any investigational treatment or trial opportunity.
* While the correspondence between the FDA and a clinical trial sponsor is strictly confidential, including IND numbers, we do confirm that all clinical trials sponsored by Stemedica have FDA approval. These trials are listed on the governmental web site ClinicalTrials.gov under the following numbers:
STEM 101-M; NCT01297413 A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke.
STEM 102-M; NCT01771679 Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging.
STEM 103-M-STEMI; NCT01770613 A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With ST Segment Elevation Myocardial Infarction (STEMI)
STEM 104-M; NCT02123706 A Phase IIa, Single-blind, Placebo-controlled, Crossover, Multi-center, Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-ischemic Etiology.
We, too, wish Gordie Howe the best of health in the future. We trust that Gordie’s participation in Novastem’s stroke study at Clinica Santa Clarita fulfills the time-honored purpose of clinical trials.
Thank You,
Stemedica Cell Technologies, Inc.”
Based on the previous history of treating patients in Moscow and Tijuana, I would want to know what other drugs were given around the time of the transplant (pre- and post-op), including steroids, antidepressants, stimulants, etc…since the rapid onset of action does not seem to coincide with the expected delayed onset of action of stem cells.
There are a lot of unanswered questions.
Dear Professor Knoepfler,
could you please ask Stemedia these additional questions?
Because only if Stemedia is willing to answer this details, we can evaluate this kind of therapy.
And if this therapy is really working, Stemedia will answer.
If Stemedia won`t inform us about the details, everybody could make up his mind…
Please let this discussion go on
Another question. Why only MSCs in the U.S. FDA approved clinical trial while both Nueral stem cells and MSCs are being used in Mexico. How many cells and how are the cells in the U.S. trial be administered?
Dear authorities of Stemedica,
I have got some more questions and I will be glad, if you answer me.
What do you think, how ist your therapy working? Do you think the new cells have repaired the old damaged cells? or do you think, that the new cells have replaced the old damaged cells?
Have you made an MRT of the brain of Gordie Howe before and after your medical application? So you might have seen, if there are new cells in the damaged parts.of his brain ???
Please help us and give us more information about this medical wonder. If your therapy is working, it will help so many people.
Thank you very much in advance
Thank you for this interesting discussion and so many additional information.
We would like to get some more detailed information, so
Dear Professor Knoepfler, please ask Stemedica the additional questions (post of Shinsakan).
Dear authorities of Stemedica, please answer these questions.
Thank you in advance
Paul,
I applaud you for being fair and allowing Stemedica to post a response.
While Mexico raised everyone’s eyebrows, it does seem to me that this company is doing the right thing and just because every detail is not covered doesn’t mean anything nefarious is occurring here. To me, this acknowledgement by Stemedica really puts this story in the proper perspective:
“The efficacy of adult allogeneic stem cells – as is the case with all stem cells – can only be evaluated based on data collected through well run and government-approved clinical trials.”
You can’t blame the company for the media exposure it received by treating a hockey legend. The fact that Gordie Howe, by all accounts, has seen an amazing and an unexpected reversal in his health should be viewed, at a minimum, in equal parts excitement and caution with regard to hope for future cell therapies. Looking at this with a 90-100% skepticism hat on doesn’t seem appropriate given all the circumstances.
I’d bet that Stemedica would be happy to answer any other questions you might pose to them.
Paraphrasing, the journalist asked: “Was the Gordie Howe result typical?”
The CEO gave an answer that was surely biased (citing two positive results that may not have even been relevant to the stroke treatment — and making no mention of any failures).
Subsequently, above, Stemedica point out that efficacy can only be determined from clinical trials. To be consistent, the CEO should have said “I don’t know” — but he didn’t.
The inconsistency between what the CEO said and the position taken by Stemedica (above) is palpable.
Without meaning any disrespect to Paul, I think that very few people will read this blog compared to the number who watch the interview. So, the false representation will prevail.
The response doesn’t seem to actually answer many of the questions that were raised on this website. For example, exactly what treatment was used? Was it the same combination of MSCs and NSCs described in their patent application? Were the cells treated with low oxygen tension as described in the patent application? What were the characteristics of the donor(s), and how much were the MSCs expanded ex vivo? How many cells were implanted? Basically, where is even the simple information that would have been presented if this were published as a case report (and not a press release)?
In particular, it was pointed out on this website that the treatment used was obviously different from that in the US clinical trials because none of the US clinical trials use NSCs; yet, they still cite all of the US clinical trials even though these trials are irrelevant to the treatment that was actually applied. What are the details for the “government authorized clinical trial in Mexico;” inclusion/exclusion criteria, type of trial, type of intervention, etc? What was the actual clinical trial number in Mexico? Why give so much detail on clinical trials in the US that are not applicable to the situation being discussed but then basically no information on the clinical trial that the patient was actually enrolled in?
Regarding the US clinical trials, they mention that the US trials have “FDA approval” and then immediately defer to clinicaltrials.gov. However, as has also been pointed out on this website, particularly by Dr. Loring, clinicaltrials.gov is simply a site where entities register their clinical trials; it does not indicate “approval” of anything or have the authority to “approve” anything. They dance around the issue of INDs but do not explicitly state whether or not they have actually submitted IND(s) for their treatments to the FDA, although their website does indicate that an IND was approved by the FDA for the US MSC stroke trial registered at clinicaltrials.gov. Regardless, this is irrelevant because the treatment applied to Mr. Howe is MSC + NSC, i.e., different from the MSC treatment in the IND. Interestingly, though, Stemedica appear to have submitted an IND in the US for NSCs back in 2011 for treatment of spinal cord injury, but there is no indication that the IND was approved or any registration of a subsequent clinical trial; perhaps the IND for NSCs was rejected?
Perhaps most importantly, the use and source of the NSCs was also extensively discussed/questioned on this website and yet in the response there is no mention or description at all of the NSCs, particularly their likely fetal source.
I give them credit for filing INDs and running clinical trials in the US for their MSC therapies and hope they follow it up with publications in legitimate peer-reviewed journals. However, in this particular case, the conspicuous lack of details in the response is troubling; it would have been really great if they had taken this opportunity to provide more information.
Thanks for posting Stemedica’s response. Patients For Stem Cells appreciates hearing what they had to say.