OT: DID STEM CELLS REALLY HELP GORDIE HOWE?
By Bradley J. Fikes | U-T San Diego DEC. 25, 2014
Hockey legend Gordie Howe is making a dramatic recovery from a serious stroke thanks to stem cell therapy developed by San Diego-based Stemedica, his family says. Some medical scientists aren't so sure, however.
Howe, 86, suffered the stroke in late October, leaving him unable to walk and disoriented. He began improving within hours after receiving the stem cells in early December, said Dr. Murray Howe, a radiologist and one of Howe’s sons. For example, Howe insisted on walking to the bathroom, which he previously could not do.
"If I did not witness my father's astonishing response, I would not have believed it myself," Murray Howe said by email Thursday. "Our father had one foot in the grave on December 1. He could not walk, and was barely able to talk or eat."
"Our father's progress continues," the email continued. "Today, Christmas, I spoke with him on FaceTime. I asked him what Santa brought him. He said 'A headache.' I told him I was flying down to see him in a week. He said, 'Thanks for the warning.'"
Howe is receiving speech and physical therapy at his home in Lubbock, Texas, and his therapists say he is much better than before receiving the stem cells.
Howe received the treatment from Novastem, a Mexican stem cell company that has licensed the use of Stemedica's cells for clinical trials approved by the Mexican government. Howe was given neural stem cells to help his brain repair damage, and stem cells derived from bone marrow to improve blood circulation in the brain. The procedure took place at Novastem's Clinica Santa Clarita in Tijuana.
Such use of unproven stem cell therapies outside the U.S. clinical trial system draws objections from some American health care professionals. They warn of the potential for abuse, say there's a lack of rigorous scientific standards, and call for tighter federal regulation of the proliferation of stem cell treatments.
Nevertheless, patients with ailments that don't response to approved treatments continue to seek such care. These patients and families say they have the right to make their own judgments. And they may not have time to wait for proof, so they're willing to take a chance.
Stemedica says it follows U.S. government law, and requires those licensing its stem cells in foreign countries to obey the laws of those countries.
The elder Howe has dementia, but since the stem cell treatment his word recognition has improved and he's more "interactive" in conversations, Murray Howe said. His two brothers and sister have also attested to the elder Howe's mental and physical improvement in media accounts.
A physical therapist who works with the elder Howe, Deirdre Bailey, said Thursday he showed "marked improvement" when she saw him a few days after the stem cell therapy. Previously able to stand only with extensive help, Howe could stand and walk on his own, although unsteadily and in need of close watching.
Bob Jones, a speech language pathologist who has worked with Howe over the last several weeks, said Thursday that Howe greatly improved his understanding and response to questions after the treatment. He was further improved when seen on Thursday of last week.
"He interacts more than he had before," Jones said. "He responds appropriately to such things as proverbs, idioms similes," when prompted to complete them. His speech, almost unintelligible before, is less difficult to understand.
And echoing a theme in Murray Howe's FaceTime Chat, Jones said something else emerged that was absent before treatment: a sense of humor.
U-T San Diego asked Murray Howe to arrange for permission to speak to Howe's therapists, in compliance with law governing the privacy of health care information.
Novastem announced on Wednesday the first treatment in its Mexican clinical trial. The description matches Howe's treatment, but the press release didn't disclose the patient's identity.
If Howe continues to improve, he may be able to make a scheduled joint appearance with another star who made hockey history -- Wayne Gretzky. The two are scheduled to appear Feb. 6 at the 55th Annual Kinsmen Sports Celebrity Dinner, in Saskatoon.
DOUBTS AND RESPONSE
Two prominent skeptics of what they view as unregulated and overly hyped stem cell treatments say one patient’s experience isn’t enough to establish a causal relationship. Properly controlled clinical trials are needed for that, say stem cell researcher Paul Knoepfler of the University of Davis, and Dr. David Gorski, a surgical oncologist.
Knoepfler and Gorski, who frequently blog on the need for sound science in medicine, are not involved in Howe’s care. They are seeking information from Stemedica and Novastem to supplement what they’ve gleaned from media accounts. Among other things, they say taking Howe for treatment in Mexico, outside of U.S. regulations, is a warning flag.
The two say the publicity surrounding Howe's case could spur false hope for other patients, causing them to pay large sums for experimental treatments. (Howe's treatment was paid for by Novastem). And Novastem's president, Rafael Carrillo, cautioned against extrapolating from one case.
"Expect different things for different patients," Carrillo said. "Mr. Howe had a great response, by what I see in the paper. And with time we'll be able to tell you with more certitude what results, if any, can be expected."
Gorski posted an extensive analysis of what he found dubious on the blog Science Based Medicine, at utsandiego.com/howegorski. Among his objections is that the resumes of Novastem's doctors don't show special expertise in stem cells. According to Novastem's Web site, the leader of the stem cell treatment program, Dr. Clemente Humberto Zúñiga Gil, has experience in treating the elderly, but he's not listed as having specific expertise in stem cell therapy.
The treatment of Howe, known as "Mr. Hockey," took place over two days. The first day, Howe received neural stem cells, injected intrathecally, or into the fluid surrounding his spinal cord, to reach the central nervous system. The next day, Howe got an intravenous infusion of mesenchymal stem cells, derived from bone marrow.
"I'm not aware of convincing preclinical data that would give a strong likelihood of safety and efficacy of such an approach," Knoepfler said by email Wednesday. He blogs about stem cell and science issues at ipscell.
"While intrathecal administration of stem cells addresses the problem of getting cells into the CNS, it potentially could have higher risks too such as abnormal tissue growth or even cancer," Knoepfler wrote. "IV administration of stem cells faces the challenge that data suggest that this approach does not lead to stable engraftment of cells and indeed such cells are rapidly removed from the blood stream by the body, often in the lungs where there is a risk of pulmonary emboli."
As for the mesenchymal stem cells, Knoepfler wrote that he was likewise perplexed about how they could benefit Howe.
"In principle, stimulating vascular regeneration could help stroke victims, but it's unclear to me how systemic IV administration of MSCs could specifically stimulate vascular growth in the brain and specifically in the regions of damage due to the stroke," Knoepfler wrote. "Does this team have preclinical data that suggest this approach works?"
Murray Howe, who was told of the objections, agrees that more rigorous trials are needed, but said by email that as an experienced physician he is qualified to assess the treatment.
“I don't claim to be a stem cell expert. But, I am certainly an expert in my dad's medical condition,” the younger Howe said. “And I am fortunate enough to have experienced first-hand dragging my father's dead weight onto an airplane and requiring all of my huge brother Marty's strength to transfer Mr. Hockey from chair to chair. And both my brother and I witnessed him walking in less than 24 hours with assistance, and five days later being able to sweep, rake, and do dishes completely under his own power.”
ICON IN TROUBLE
Howe's case has attracted national attention because of his fame. Although he retired in 1980 at the age of 52, the man known as "Mr. Hockey" exceptionally long career and records made Howe an enduring icon. His physical stamina continued well into old age; a profile of Murray Howe last year in the Toledo Blade opens with an anecdote of the elder Howe sweeping the sidewalk in front of his son's home.
But in recent years Howe's mind began ebbing as dementia set in. And on Oct. 26 of this year, Howe experienced a major stroke.
Stemedica is conducting a U.S. clinical trial of its cells for ischemic stroke, in which blood supply is blocked to part of the brain. This is what Gordie Howe suffered. However, the trial requires participants to have had the stroke at least six months ago. So Howe wouldn't qualify until late May.
Even more to the point, there was substantial doubt whether the elder Howe would survive for six months, or even until Christmas, said Murray Howe. Howe enjoys physical activity, and if unable to move he would lose his will to live.
That is when Stemedica stepped into the picture, helping Howe connect with Novastem and get free treatment. The therapy would have cost about $20,000, said Novastem president Carrillo. Patients are charged to cover the cost of treatment, he said.
Dave McGuigan, Stemedica's vice president of marketing and business development, said he encouraged Stemedica to help Howe because of his loyalty to Howe and the Detroit Red Wings, Howe's longtime hockey team.
"My first job out of college was with the Detroit Red Wings," McGuigan said. "I developed a community outreach program using injured and retired players. I was 21 years of age. One of the retired players that helped me the most was Gordie Howe ... and his wife, Colleen. We did a Gordie Howe roast for amateur hockey in Michigan, we had 1,400 people come; we did a fundraiser in Chicago that Gordie participated in."
After reading of the elder Howe's stroke, McGuigan said that with Stemedica's support, he reached out to Murray Howe and offered the stem cell therapy. It couldn't be given in the United States because of the six-month waiting period.
"When I was contacted by Stemedica just prior to that hospital admission, I was beyond skeptical," Murray Howe said in his email. "But based on the information at hand, we as a family concluded that the treatment was safe, might help, and that we had nothing to lose. This was a Hail Mary pass."
BELOW IS THE COMPLETE TEXT OF MURRAY HOWE'S THURSDAY EMAIL DEFENDING HIS FATHER'S STEM CELL TREATMENT:
I've read with great interest the blogs from a handful of skeptics in the stem cell research community. I fully understand their skepticism and questions raised. I am well-positioned to respond. If I did not witness my father's astonishing response, I would not have believed it myself.
I have been practicing medicine almost 30 years. I graduated from University of Michigan Medical School in 1986, where I also continued with my radiology training. I was thus trained in a highly academic, research-oriented environment. Following my training I served as a department chair for over 15 years, much of this at our flagship Toledo Hospital a nearly thousand bed campus tertiary care level one trauma facility. I head our sports medicine imaging program and am a full-time clinician. I am confident that my credentials attest to my capacity to be a reliable witness.
I am happy to share my experience with my father's stem cell treatment.
Our father had one foot in the grave on December 1. He could not walk, and was barely able to talk or eat. This can be confirmed by the attending physicians at UMC hospital in Lubbock.
When I was contacted by Stemedica just prior to that hospital admission, I was beyond skeptical. But based on the information at hand, we as a family concluded that the treatment was safe, might help, and that we had nothing to lose. This was a Hail Mary pass. I certainly cannot criticize the people at Stemedica for having the courage and kindness to reach out to us. It's easy to accuse any act of kindness as having ulterior motives. The people at Stemedica were beyond gracious, and there were no strings attached to their offer to help our father. They never have asked us to share Mr Hockey's amazing response. We as a family felt obliged to give credit where credit is due.
I wholeheartedly agree with critics who say that more research is needed on stem cells. Based on what I've seen, I would say we should intensify our research efforts because this technology is poised to transform medicine as we know it. But Mr. Hockey did not have the luxury of waiting for 6 months for a U.S. stroke trial, or even 30 days for a Compassionate IND treatment in the United States. I applaud the U.S. FDA for its cautious, methodical approach. For the population at large this is the prudent approach. For Mr. Hockey though, we just couldn't wait. What would you do for your father in such a situation?
Concerns were raised regarding the technical nature of our family press release. I drafted the release, and thus I wanted to assure its accuracy and informative nature. I included a website address for Novastem because I wanted the world to know how grateful we were for their care. I believe they have the potential to help many people suffering from stroke, dementia , traumatic brain injury, spinal cord injury, and more. I believe time will back-up my assertion. I also ran my draft by Stemedica and Novastem to assure its accuracy and as a courtesy to them, as I would do for anyone. But the words are mine. Period.
Did Novastem treat our father for free? You betcha. They were thrilled and honored to treat a legend. Would you charge Gordie Howe for treating him? None of his doctors ever do. I certainly am not going to criticize them for being generous.
I find it fascinating that anyone would criticize Novastem for charging, or for not charging, for their services. They appear to have developed techniques and protocols which are safe and hold promise for countless individuals. My hat is off to them for the quality service they offer.
Some have criticized the fact that our father was treated in Mexico. Our choices were Russia or Mexico because my father could not receive the intrathecal (intraspinal) injection in the U.S. yet. However, the intrathecal route appears to be more effective than IV route only for my dads condition, which includes dementia, stroke, and traumatic brain injury. This was my conclusion based on the information at hand. More research will be needed to confirm this, certainly.
I don't claim to be a stem cell expert. But, I am certainly an expert in my dad's medical condition. And I am fortunate enough to have experienced first hand dragging my father's dead weight onto an airplane and requiring all of my huge brother Marty's strength to transfer Mr Hockey from chair to chair. And both my brother and I witnessed him walking in less than 24 hours with assistance, and 5 days later being able to sweep, rake, and do dishes completely under his own power.
I watched as he rattled off the names of objects as the speech therapist tested him after the treatment. The therapist's words were: "This is amazing!" His astonishing recovery was witnessed by a physiatrist M.D., a nurse, and the objective measurements of a physical therapist, occupational therapist, and a speech therapist. In addition, my brothers, sister, and I witnessed it with our own eyes. I've got the videos to prove it as well. But if you cannot accept the reports from that many witnesses, you might not believe the video footage. I understand.
Our father's progress continues. Today, Christmas, I spoke with him on FaceTime. I asked him what Santa brought him. He said "A headache." I told him I was flying down to see him in a week. He said "thanks for the warning." He is showing continued progress according to my sister. He is rarely dropping items with his right hand which is an improvement (the one affected by his stroke) but when he does drop it, he is now catching it in mid air.
To date, medically speaking, I would describe his response to treatment as "miraculous." Had I not seen it, I'm not sure I would believe it either. If he died tomorrow, we would still consider this a success, because Novastem gave him back his quality of life.
I feel sorry for anyone who finds this miracle "troubling." This is truly the most astonishing, exciting news I have seen in my 54 years on this planet. And the best Christmas gift ever. We are truly indebted to the teams at Novastem and Stemedica, and to the media that share our experience with the world.
AI
