Kathy Loper, Director of Cellular Therapies at AABB (formerly American Association of Blood Banks), is one of those rare souls who has always known what she wanted to do with her life. From the time she was a small child reading medically-focused sci-fi thrillers and looking forward to science class in school, Loper has been sure that she wanted to work in the medical field.
Originally from Shreveport, Louisiana, Loper has steadily built a career in medicine – and more specifically, blood-related sciences. After working in hematology at a VA medical facility, Loper spent time in the bone marrow transplant program at LSU, followed by a stint in a stem cell processing and gene therapy program at Johns Hopkins Hospital.
Although she has changed positions and stepped into new roles within the field of science, Loper appreciates the fact that she never really leaves her colleagues behind. Because it’s a relatively small field of professionals, Loper maintains contact with peers from Johns Hopkins and LSU while staying in touch with researchers from around the world.
“AABB is an official patient safety organization. We’re a non-profit that works with 8,000 individuals from 80 countries and 1,800 institutions,” Loper explained.
Among the services offered by AABB are publications, books, audio conferences and information packages that educate individuals and institutions about cell therapy. AABB also hosts an annual meeting that educates approximately 7,000 people. Although her department has a full plate, it was ultimately the lure of service expansion at AABB that drew Loper to her current position.
“We’re focused on bringing more members in and meeting their professional needs,” Loper said. “We want to be the premier resource in the cell therapy field. When someone needs information we’d like people to think of us first.”
AABB is funded through membership dues and corporate donations. The process allows the organization to expand in a meaningful way. “It lets us offer more services to better serve those members,” Loper said.
In spite of continual networking, meetings and travel, Loper claims to love her job. “I’m motivated by the idea that we will be able to harness the immune system in order to treat or cure diseases. I get to work with some amazing people!”
It seems that Loper has cause for optimism and spoke of the changes in cell therapy she has witnessed in the past 23 years. She recalls a time when stem cell transplants were not an accepted form of treatment for very sick patients, when insurance companies would not pay for it. That, of course, is no longer the case.
She is further heartened by increased global collaboration. “Depending on the year you look a,t about one-half of unrelated stem cell transplants cross international borders. We’re a global industry because of the need to match stem cell transplant products by tissue type. People move around so the best match for a patient may not be local.”
As for the future, Loper believes that the way stem cells are delivered may be altered so that they can be better targeted. She also believes that as we learn more, we will find that cell therapy doesn’t work well for some conditions, but does work well for others. Loper looks forward to watching current research – such as regeneration of tissues and blood vessels -- emerge from the pipeline.
While she looks toward to the future, Kathy Loper loves her life today. She calls the colleagues she works with at AABB “amazing” and says that their enthusiasm is contagious.
That’s really the best scenario anyone can hope for.
Like 25 percent of all Chronic Obstructive Pulmonary Disease (COPD) patients, Barbara Hanson, now 62, never smoked. Yet upon diagnosis, Barbara knew that she would likely spend a lifetime dealing with the symptoms of the disease: coughing that produces large amounts of mucus, wheezing, shortness of breath, tightness in the chest, and fatigue.
Ms. Hanson, knew that she was sick by 2002, but it wasn’t until 2006 that she was given the official diagnosis. “They told me to exercise, take all these medications, and go home and get my stuff in order,” she said. “I didn’t think that sounded very good.”
Knowing that COPD is the number three cause of death in the U.S., Hanson simply did not have the disposition to take it lying down. Instead, she began to investigate her options.
In 2007 she found an online forum that served as a meeting place for people with COPD. She was frustrated by how little hard evidence she could find regarding COPD treatments, but was intrigued by one man who had gone to Argentina for a stem cell treatment and claimed to be doing better.
Along with fellow COPD sufferer Jeannine Richardson, Ms. Hanson found an outfit in California that would take them across the Mexican border for stem cell therapy. It turned out to be a shady facility and both women became ill.
“We were like babes in the woods,” Hanson says, recalling those early days of investigation.
Back home in the U.S., Hanson and Richardson doubled down on their efforts to learn more. Hanson decided to try stem cells again, but this time, did her due-diligence when determining which doctors to trust.
It was one of her children who suggested that Hanson should start her own website, dedicated to helping other COPD patients learn more about stem cells and which programs they can trust. Along with her friend, Jeannine Richardson, Hanson began Stem Cell Pioneers.
Hanson and Richardson have made it their mission to protect as many people as they can from predatory medical practices. “There are sharks in the water. Those are the ones we really expose,” Hanson said.
In addition to vetting doctors and stem cell programs, Stem Cell Pioneers also keeps the public informed as to what’s going on with the FDA and stem cell legislation.
While she helps educate and protect, Hanson still sees to her own health. Along with her physician, Dr. Terry Grossman, Hanson has come up with a health regiment that includes clean eating and acupuncture. As a result of those changes and her stem cell treatments, Hanson’s need for supplemental oxygen has become minimal. Still, she dreams of a future in which patients don’t have to fight so hard or travel so far for stem cell therapies, and says that she hopes that one day stem cells won’t be considered a drug.
While she waits for that day, Hanson offers the following tips on what to look for in a reputable stem cell practice:
Make sure they’re credentialed.
Make sure they do in-house studies.
Don’t just consider the testimonials they offer. Look into the program itself.
Don’t trust any physician or clinic that promises you a cure.
Make sure the doctor or doctors you are working with are active in the scientific community.
Hanson admits that helping run Stem Cell Pioneers has given her tough skin. “There are a lot of quacks out there,” she said. “If we see doctors who raise red flags we’re going to write about them, whether they like it or not.”
Don and Gloria Reed raised two children; daughter Desiree’ and son Roman. An injury sustained by Roman in a 1994 college football altered the Reed’s world.
The entire incident is etched in Gloria Reed’s mind. “It was such an odd day. I’d gone to a bridal shower before the game, but couldn’t make myself stay for the cake. I was just a nervous wreck. I went by my aunt’s house and she asked me, ‘What’s the matter?’ I told her that I didn’t know what was going on.”
The anxiety clung to Mrs. Reed as she and her husband watched the football game from the stands. Because it was she who most encouraged Roman to play football, she couldn’t understand why she was filled with such trepidation.
If Don Reed was nervous that night, he kept it to himself. Two weeks prior, Mr. Reed had a terrible nightmare about his son in which Roman’s head was on one side and his body on the other. Still, Roman was an athletic young man who had never so much as broken a bone. Logic dictated that this game would be no different.
“I could see Roman was getting tired,” Gloria Reed recalled. “I told my husband that I wanted to go down and stop the game. He said, ‘You can’t go down and stop the game; it’s college football!’”
Mrs. Reed happened to be videotaping the game and has on tape the play that forever changed her son’s life. She recalls Roman being transported to the hospital, receiving the grim diagnoses, and coming to the realization that in all probability her son would never move on his own again.
The family was galvanized into action. Desiree, who had always been very close to her younger brother, returned from law school in Tennessee and along with Roman’s girlfriend, Terri, began studying everything she could find on treatments for paralysis. One of those treatments involved embryonic stem cells.
While Don accompanied his son to Palm Springs for intense physical therapy, Gloria stayed home to see to the business of making the house handicap-accessible and fighting with their insurance company. It was six months before Roman moved back home, and by then the family was exhausted. 5 feet 11 inch Desiree went down to a size zero and the rest were running on fumes, motivated only by Roman himself.
Roman went into that game as a kid, but came out as a man,” his mother said. He was wonderful. I couldn’t let myself fall apart because Roman wasn’t falling apart.”
“Roman is an amazing man,” agreed his father. “I looked at my son’s courage, his refusal to give up, and I knew that I had to do something.”
Don Reed became a dogged advocate for those who have been paralyzed, desperately seeking a way to help his son regain use of his body. Faced with one disappointment after another, he refused to give up. Asked why, Mr. Reed answered, “What would you do if your child was on fire?”
Pete Stark, congressman in the Reed’s district, helped the family secure an experimental medication from Switzerland that helped Roman regain limited use of his arms.
Although it wasn’t a total success, the physical change was enough to spur the family on. As a former junior high English teacher, Mr. Reed appreciates the power of the written word and wrote a play about diversity, intended to help raise money for paralysis research. The money earned was sent to the Christopher Reeve Spinal Cord Injury and Paralysis Foundation. Mr. Reeve thanked the family in a written note, adding that one day he and Roman would both be able to walk away from their wheelchairs.
Although the proceeds from the play were a good start, Mr. Reed knew that it would take far more money to make a dent in finding a cure. In 1997 that he began a writing campaign, sending letters to anyone and everyone who could possibly help make a difference. It was Congressman John Dutra who responded. The congressman agreed that the medical research Mr. Reed dreamed of needed to be funded. He also believed that California taxpayers would be willing to take part in that funding. And so the idea for the Roman Reed Spinal Cord Injury Research Act of 1999 was born. The Act raised $14 million for research, with an addition $64 million coming from the National Institutes of Health and other sources. Although funding to this program was recently cut, the Reed family has rolled up their sleeves and is now working to restore it through a $1 traffic ticket add-on.
While most people would consider giving up at this point, Don Reed was not one of them. “I’ve seen so much sadness,” he said, “but Roman does not go to that place. He still deals with pain, 24 hours a day, with no days off.”
Mr. Reed also joined forces with Palo Alto real estate developer Bob Klein who had become interested in stem cells as a way to help his son fight Type 1 diabetes. Klein’s passion led to the birth of Proposition 71, a bond issue that would raise 3 billion dollars for stem cell research. In 2004, ten years after Roman Reed was first injured, that bond passed.
Proposition 71 (also called the California Stem Cell Research and Cures Act) makes conducting stem cell research a state constitutional right. The three billion dollars raised through the sale of general obligation bonds is to be used over the course of 10 years to finance stem cell research, including study of embryonic stem cells.
In spite of the political victory, Mr. Reed still meets with frustration in his fight to find a cure. “It’s rough to be called names when we’re trying to help scientists save lives. People say the most vicious things.”
Although he’d love to see his son climb out of that wheelchair sooner rather than later, Mr. Reed knows that patience is key. “It took them 17 years to come up with a vaccine for polio,” he said. “And that was with the help of four presidents, a cooperative congress, and the March of Dimes.”
He sees stem cell research as a natural response to the number of chronically ill people in the U.S:
“$1.65 trillion were spent on chronic diseases in 2009. That’s more than the $1.6 trillion national debt for that year, and more than all our federal taxes put together. We either have to find cures or the country is going down economically.”
As Sponsor of the Roman Reed Spinal Cord Injury Research Act and Co-Chair of Californians for Cures, Mr. Reed has a saying he likes. “If you never give up, you can only win or die. And everybody dies, so why not try?”
Whether he caught the optimism of his parents or they caught it from him, Roman Reed now lives a full life. He finished college, found a career he cared about, and married the girlfriend who was with him at the time he was injured. The couple has also provided Don and Gloria Reed with three of their four grandchildren.
Mr. Reed summed it up by saying, “Roman just doesn’t give up.”
Dr. Carlos Castaneda
Dr. Carlos Castaneda was not one of those kids who waffled between whether he wanted to be a fireman or astronaut when he grew up. According to the Tijuana-based plastic surgeon, he has known his entire life that he wanted to be a doctor.
“At first I wanted to be a pediatrician because that was the doctor I went to,” Castaneda said. “But during anatomy courses in first year medical school, working on cadavers, I realized how interested I was in anatomy.”
What better way to indulge his interest in human anatomy than to help people accomplish their aesthetic goals and to be part of a medical procedure that gives the body a chance to heal?
After more than a decade of study and practice, Dr. Castaneda is with Cosmed in Tijuana, an aesthetic and reconstructive medical practice. He also works with Regenerative Medicine Institute, Mexico, frequently serving as the board certified plastic surgeon in charge of removing the stem cell rich fat which is ultimately used to treat a myriad of chronic health conditions.
Although Dr. Castaneda downplays his role in the stem cell process, he concedes that fat removal should be performed at the hands of an experienced plastic surgeon.
“It has to be done by somebody who is trained so that there are no complications. When you hear about one of those clinics where one doctor does it all, you know it’s probably just not going to work. I can take stem cells and have them processed, but for me to put those stem cells into a heart through a leg vein would be professional suicide,” Castaneda said frankly.
He describes doctors who claim to be able to do it all as “without scruples.”
According to Dr. Castaneda, it’s those unscrupulous doctors who make everyone look bad. “People coming from the States will look at Tijuana and say, ‘Oh, we’ve heard horror stories.’ But those are at the hands of untrained surgeons.”
In fact, the doctor is part of an association whose mission is to prevent patients from falling into the hands of quacks with smooth sales pitches, but little medical expertise. A big part of that process involves educating potential patients.
In Castaneda’s case – both in private practice and with RMI – it’s a matter of specializing. While one doctor in his practice works on faces, Castaneda is an expert in body contouring. Although he’s not doing much body contouring with RMI, he is excited about the results he’s seen.
“We’re getting constant reports on patients doing so well. For example, the people we’ve worked on with severe joint problems that are up-and-about now,” he said. “Even some fellow plastic surgeons aren’t sure if they believe it when I tell them about stem cells, but the research proves that it works.”
Dr. Castaneda calls stem cell research, “the most promising field in medicine.”
“I always tell the patients that this is cutting-edge, and that this is going to revolutionize the way we treat some conditions.”
Dr. Miguel Osuna Millan
Dr. Miguel Osuna Millan is a dentist and currently presides as head of the Health Commission at the Federal Mexican Congress. The congressman spoke of his motivation for crafting new legislation aimed at providing uniform stem cell care in his country. "The spirit of the reform was to make sure that what's going on in the Mexican legislature is in keeping with what's going on in the world," he said. "The idea is to save lives and to offer better quality of life."
On December 7, 2011 the lower chamber passed Osuna Millan's new, progressive legislation. The senate is expected to hear and decide upon the laws in September 2012.
Dr. Osuna Millan is no newcomer to championing health. It was due to changes first proposed by him that 10 million more Mexicans now have health insurance. He sees stem cells as one more way to help the sick. "I think that stem cells will become a regular form of treatment first in border cities due to the number of medical tourist, but I do believe that we're on the road to seeing stem cells available to everyone," the congressman said.
Among the changes introduced by this new legislation are:
Any hospital or clinic dealing with stem cells must be licensed by the federal government. Failure to meet standards set forth by the legislature and COFEPRIS (the Mexican equivalent of the U.S. Food and Drug Administration) will lead to monetary fines, suspension or revocation of license.
All providers of stem cells must establish a transplant and transfusion committee to oversee their work.
The use of stem cells of animal origin is strictly forbidden.
A new state funded program that allows new mothers to donate the umbilical cord of their newborns, thereby assuring that cord blood is available to those in need.
Stipulation that stem cells derived from placental blood or bone marrow will be limited to use in hematological (blood) diseases.
Permission to export stem cells or tissue abroad.
The congressman is especially proud of the fact that umbilical cords that would once have been thrown away can now be used to save lives and that stem cells not being used in Mexico have the potential to save lives in other countries. “We used the European Union as a model,” he said. “In Spain there was a surplus of stem cells and tissue that were sent to countries with a deficit of these life-saving resources.”
A commonly-held concern regarding medical care in Mexico centers around physician oversight and who looks out for patient safety. According to Dr. Osuna Millan, this legislation will be one more step toward alleviating those concerns and creates a legal frame work that allows COFEPRIS (the Mexican equivalent of the FDA) to have enough teeth to ensure that all stem cells programs in Mexico meet basic patient safety standards.
"This legislation was only made possible by members of the lower chamber putting politics aside long enough to work together toward a healthier Mexico, said Dr. Osuna Millan. Not only will Mexicans benefit, but also the thousands of medical tourists who travel to Mexico every year."
Dr. Osuna Millan summed it up by adding, “I hope this empowers all states to promote innovation and novel therapies in order to help the greatest number of people get well.”
Dr. Ron Rothenberg
It may be difficult to imagine today, but when Dr. Ron Rothenberg first began practicing medicine in the 1970s there were no emergency room specialists. That’s not to say there were no doctors specializing in emergency room procedures, but the American Medical Association had not recognized them as a breed, unique unto themselves.
It can take a while for the medical establishment to adopt new specialties, even after years of practice. “Very little has changed in the practice of medicine since I was in med school,” said Dr. Rothenberg. “ We have higher levels of technology and newer antibiotics, but we’re still managing our patients with conventional medicine.”
Dr. Rothenberg made his voice heard in those early years of medical practice by asking the state of California to provide continuing education to emergency room practitioners. Several decades later emergency care is considered a specialty, complete with its own training.
Today, Dr. Rothenberg is known as an anti-aging expert, driven by an internal need to learn what’s over the next scientific hill. “I’m always looking for original research. You can’t continue on inertia,” he explained.
He’s inspired by learning more about the science of medicine, by having stronger information to share with his patients. Part of his current practice involves working with men and women as they move through the aging process.
Dr. Rothenberg said that, “Andropause in men has just as many severe consequences and symptoms as menopause in women. Both are hormone deficiencies and need to be treated with bioidentical hormone optimization.”
With a thriving practice in Encinitas, a full travel and speaking schedule, and time built in for his surfing habit, Dr. Rothenberg packs a lot of living into his life. Still, he remains dedicated to learning more about the latest medical techniques and to delve into scientific data as it becomes available. He believes he knows which way the scientific evidence is pointing.
It was through a colleague that Rothenberg first learned of the clinical trials being performed at Regenerative Medicine Institute, Mexico. He calls the stem cells found in fat – like those harvested at RMI – the “richest” stem cells in the body.
Calling stems cells “our built-in repair kit,” Dr. Rothenberg feels confident in suggesting the treatment. In fact, he has referred patients to the trials conducted at RMI.
“I expect in the future there will be a merging of conventional and new medical techniques. There are no separate conventional and alternative medicines. We need to have open minds to everything that is safe and effective. You can’t stop a tidal wave of information.”
Dr. Rodrigo Robledo
Dr. Rodrigo Robledo has a full plate. In addition to operating a thriving dental practice, Robledo is commissioner of The State Commission for Medical Arbitration, State of Baja California. The Commission is responsible for hearing patient complaints against medical practitioners.
According to Dr. Robledo, 350,000 Californians seek medical treatment in Mexico each year. Some travel out of country in order to obtain more affordable medical care, while others prefer the level of attention they receive from Mexican doctors.
“The U.S. has the best diagnostic equipment in the world,” Robledo said, “but patients frequently spend their time with medical assistants, nurses and other support personnel. They don’t get real time with their doctors. In Mexico, we spend time with our patients, we know them, we know about their families. It’s a more personal relationship. Many doctors in the U.S. spend more time dealing with insurance.”
One of the things foreigners worry about as they consider travelling to Mexico for medical treatment is physician oversight. Dr. Robledo says that patients often don’t realize that there is a body actively overseeing their protection.
The mission of The State Commission for Medical Arbitration is two-fold, according to Robledo. “We protect the ethics of doctors and protect services for society.”
In the event a patient has a problem with his treatment or a misunderstanding with his doctor, he can make a report to the Commission. In turn, the Commission investigates every complaint. In some cases the solution is as simple as the physician returning the fee paid for services. In more serious cases, the doctor can be reprimanded, lose his license, or be charged with a crime. The most serious cases are turned over to the Attorney General’s office.
“The media would have people believe that it is not safe to travel for medical care. What they don’t say is that we work hard to protect patients, to give them a place to voice their concerns,” Robledo said.
The process is as easy as filling out a form. Every complaint turned into the Commission is investigated, regardless of how trivial the matter may seem. According to Dr. Robledo, complaints filed by foreigners are pursued as vigilantly as those filed by Mexican citizens.
The influx of medical tourism is likely to grow. According to the Commissioner, by 2015, 40 percent of baby boomers will need some type of health services. A large percent of those visitors will come to border states like Baja, California.
“People don’t know about many of the things the government is doing to protect them,” said Dr. Robledo.
When you imagine a guy with a master’s degree in French Revolutionary history you might not picture Wyatt Earp, but David Audley and Wyatt Earp do have something in common. Both men were charged with taming the “Wild West.” Earp, of course, worked to maintain order in rowdy places like Dodge City. Audley works to maintain order in the new frontier of stem cell treatment.
As Executive Director of the International Cellular Medicine Society (ICMS), Audley must oversee 2,800 aligned members from 36 countries, many hoping to be accredited by his agency. Audley describes ICMS as, “a patient safety organization.” As such, ICMS investigates the transparency and efficacy of programs that offer stem cell therapies.
Accreditation by ICMS is a fairly new development. “We had clinics who were claiming that because they had someone affiliated with us, they were part of ICMS. In order to address the problem we initiated two things. First of all, any professional who wants membership must apply. And secondly, we began the accreditation process.”
In order to be accredited by ICMS – the only true accreditation body of its kind – physicians and medical groups are carefully vetted. They must prove that they are safe and that they have treated enough patients to provide a fair picture of how effective their treatments have been. While Audley says that some of the groups going through the accreditation program are “close” to approval, there are still investigative steps to be taken.
The goal is to provide patients with the assurance that when they’re treated by an ICMS-accredited physician, they’re in well-trained, ethical hands.
Asked what patients should look for in a stem cell therapy program, Audley gave a three-part answer. “Transparency. It should be obvious what they’re getting. They should hear about possible outcomes and how the treatment they’re receiving has worked for other patients. Oversight. They should find out if their doctor has anyone looking over his shoulder to make sure things are being done right. And they need follow up. That doctor should not just treat them and send them on their way. A patient should know that someone will be following up on their case.”
A high quality stem cell program will let patients know up front what they’re in for and what kind of results they can realistically expect. “People are messy,” Audley said. “We smoke, drink and do all kinds of nasty things to our bodies. Yet we expect the same outcome as someone who doesn’t do these things.”
Audley’s wish is that in 10 years stem cell treatment will be simply one more weapon in the medical arsenal. “I hope it’s a tool that can be paired with other treatment options. It’s not magic pixie dust, but part of an overall approach to healthcare.”
While we wait for that day to arrive, Audley will be busy playing sheriff in the Wild West of cutting-edge medical treatment.
Barbara Krutchkoff, Founder and CEO of A3Cell, summed it up by saying, “If physicians want to do stem cells, David is here to help them do it right.”
Diego Rivera 2339-PH
Zona Río, Tijuana, C.P. 22010