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.
Stemedica Cell Technologies, Inc.”