The latest research treating frailty in older adults makes significant headway, using a type of stem cell scientists are studying to treat a variety of diseases
Is stem cell treatment the wave of the future? A pair of recently completed studies certainly seem to point in that direction.
The Phase I and Phase II research aimed to prove the safety of stem cell treatment for older adults with frailty, a geriatric condition characterized by lowered energy levels, weakness, and loss of muscle mass. The condition increases the odds of catastrophic injury, and is found in nearly 10 percent of 50 million older Americans.
Study results were surprisingly encouraging. The stem cell therapy was not only safe, but quite effective in reversing age-related frailty, according to researchers at the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine. There is currently no FDA-approved treatment for aging frailty.
Mesenchymal Stem Cells
The trials involved mesenchymal stem cells (MSC), which are also being studied to fight a range of conditions from cancer to heart disease. All adult stem cells can self-regenerate and form progeny of many different types of cells, but this ability is reduced as people get older. That’s why the studies used stem cells from the bone marrow of donors between the ages of 20 and 45.
Phase I and Phase II Trials
The average age of trial participants was 76, all with age-related frailty. None of the injections produced adverse health effects.
In the first trial, 15 patients got one intravenous injection of MSC infusion from a younger donor. Every patient showed improved fitness and tumor necrosis levels, and a better overall quality of life when tested six months later.
The second trial was bumped up to a randomized, double blind (neither the patients nor the administrators knew which injections contained MSC and which were placebos) study. Once again, no negative effects were reported.
Nine Facts about Stem Cell Treatment You Should Know
Stem cell treatments have the potential to treat a wide range of diseases, injuries, and other health conditions. However, many clinics may make unfounded claims that are not backed by science to lure in customers who pay thousands of dollars for “therapy”. Here are nine facts from the International Society for Stem Cell Research to help you and your healthcare team understand both the potential and limitations of stem cell treatment to make a decision about what is right for you.
1. Few current stem cell treatments have been proven safe and effective.
Certain bone, skin and outer-eye injuries and diseases use stem cells with implanted tissue to aid the healing process. Some blood and immune system disorders can successfully be treated, and stem cells may be used to rebuild the blood system after certain cancer treatment regimens. This list is relatively short. Other purported therapies offered without regulatory approval should be considered highly experimental. Thoroughly check any other applications of stem cells and demand proof of legitimate and registered clinical trials.
2. An unproven treatment can cause damage.
Serious health, personal and financial problems can result from risky treatments. It may be tempting to try a novel treatment when so many trumpet unproven benefits, but a variety of negative consequences can result. These therapies may create new symptoms, or worsen your condition. They can render you ineligible for other treatment options. Costs related to treatment, accommodation, travel and other fees can be enormous. Talk to your doctor and loved ones before embarking on experimental treatment.
3. Different kinds of stem cells do different things.
Stem cells from different parts of your body have different functions you can learn about here. These different stem cell types have specific and limited capabilities. For instance, the blood-forming stem cells from bone marrow regenerate blood cells, and neural stem cells in brain tissue make brain cells. It’s unlikely a blood stem cell can be used to treat a brain condition, and vice-versa. Be skeptical of clinics that purport to treat you with stem cells originating in a different part of your body from your disease or condition.
4. It’s unlikely the same stem cell treatment will work for different diseases or conditions.
Scientists can make certain specialized cell types with the potential to form any kind of cell in the body using a complicated lab process starting with pluripotent stem (iPS) cells. These cells are promising in the development of new treatment strategies. However, along with embryonic stem cells, iPS cells don’t currently make good candidates. They require exact instruction to develop into the specific cells needed in the diseased or damaged part of the body. If the lab procedure goes even a tiny bit awry, these stem cells have the potential to overgrow and cause tumors when injected. Therefore, you should be wary about clinics that use the same cell treatment for a wide variety of conditions.
5. Know the science behind your condition.
If you understand what causes your condition or disease, you can better evaluate your options for treatment. For example, if you have a type of blood cancer, treatment with blood-forming stem cells is logical. But if you have diabetes, that treatment doesn’t make sense. Diabetes originates in the pancreas and blood sugar levels are only a symptom of the disease itself.
6. Don’t assume that treatments using cells from your own body are automatically safe.
Using a patient’s own cells in treatment is called an autologous transplant. It seems safer to use your own cells, since your immune system recognizes them. But there is a risk of contamination with viruses, bacteria or other pathogens capable of causing disease when the cells are reintroduced. The way the cells are manipulated before they’re returned to you can interfere with their normal function. Finally, how and where the cells are injected matters.
7. Don’t rely on patient testimonials or marketing.
The difference between doctors conducting clinical trials and clinics selling dubious treatment can become blurred when marketing materials tell you what you want to hear, and the legitimate doctors offer mostly caveats and caution.
Specialists usually get their patients via referrals, while stem cell clinics peddle directly to patients, using persuasive language on T.V. and the internet. Clinics have a financial interest in pushing their product. Furthermore, a patient may make a testimonial that is unintentionally misleading. The patient may perceive a benefit that is due to factors other than treatment, such as healthy lifestyle changes, an intense belief in the treatment, and natural fluctuations in the disease or condition. Learn more about the importance of clinical trials here.
8. Clinical trials are different than experimental treatment.
Just because a treatment is experimental doesn’t mean that it is part of a research study or clinical trial. Clinical trials have the following traits in common:
- Clinical trials build on lab-based research that indicate the treatment is likely to be safe and effective.
- Clinical trials have oversight form an independent medical ethics committee to protect the rights of participants.
- Clinical trials conform to regulatory requirements and are listed in a recognized registry.
- Clinical trials are designed to answer specific questions about a new treatment or use of a current treatment, and results are often compared to a control group.
- The cost of a clinical trial and monitoring is not borne by the participant.
Before you pay for expensive treatment, ask to see the clinical trials that it has successfully been through.
9. The scientific process to responsibly convert a hypothetical treatment into a safe and effective procedure is long and contains many steps that can’t be bypassed.
At any juncture, scientists may discover that a process deemed viable in the lab fails to work in animals, or one that worked in animals doesn’t translate to humans. Or it may work well for certain symptoms, but carry unacceptable risks. Beware of clinics that don’t follow the accepted scientific process from lab to treatment. Learn how science becomes medicine here.
Stem cell researchers continue to make advances understanding how they can help patients with a variety of conditions and diseases, but the science is young. Safe and effective treatments for most conditions are still in the future.
“These trials represent potential landmarks in the treatment of frailty,” notes Le Couter. “Both studies are early-phase trials of a small number of participants, designed primarily to assess safety, so conclusions about efficacy need to be treated with caution. Even so the results are striking and, at a minimum, pave the way for large, randomized Phase III clinical trials.”
The researchers plan to conduct a larger clinical trial phase, including 120 patients from 10 locations. If that proves successful, a final Phase III randomized trial would ensue.
“With the aging of the population, stem cells hold great promise to treat aging-related disability and frailty, improving physical capacity and quality of life,” according to Joshua M. Hare, a scientist working on the project and director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine. “There is no FDA approved treatment for aging frailty, and an enormous amount of unmet need that will only increase with the changing demographics.”
“Potential and pitfalls of stem cell therapy in old age,” Disease Models & Mechanisms.
“Stem cell therapy in the elderly osteoarthritis patient. Too little stem cells? Too late? Not so,” Caring Medical Regenerative Medicine Clinics.
“Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial.,” National Center for Biotechnology Information, U.S. National Library of Medicine.
“AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery.,”National Institutes of Health (NIH).
“Nine Things To Know About Stem Cell Treatmentss,” International Society for Stem Cell Research (ISSCR).
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