StemCell Therapy

November 16, 2022

Karen M. Wai, MD, Theodore Leng, MD, MS, and Jeffrey Goldberg, MD, PhD, Byers Eye Institute at Stanford, Stanford University School of Medicine, Palo Alto, CA

In recent years, the potential of stem cell-based therapies to treat a wide range of medical conditions has given hope to patients in search of novel treatments or cures. At the same time, thousands of rogue clinics have sprung up across the U.S and around the world, offering stem cell-based therapies before being tested for safety and efficacy. When communicating to the public about stem cell-based therapies, it is important to put any treatment claims in context.

Stem cell-based therapies include any treatment that uses human stem cells. These cellshave the potential to develop into many different types of cells in the body. They offer a theoretically unlimited source of repair cells and/or tissues. (For more about stem cells, seehttps://stemcells.nih.gov.)

Over the past three decades, the Food and Drug Administration (FDA) has approved several stem cell-based products. These include bone marrow transplants, which have been transformational for many cancer patients, and therapies for blood and immune system disorders.1 Other approved treatments include dental uses for gum and tissue growth and in skin for burns. Since the early 2000s, stem cell-based therapies have been explored in many eye diseases, including age-related macular degeneration and glaucoma.2 Stem cell-based therapies are also being explored for neurodegenerative diseases such as stroke and Alzheimers disease, and for countless other conditions.

Over time, we expect that breakthroughs will continue with stem cell-based therapies for many conditions. However, at this time, rogue clinics, driven by profits, are taking advantage of patients desperate for cures and are claiming dramatic results, often exaggerated in sensational media testimonials. The clinics may mimic legitimate practices. They may extract a patients own stem cells, concentrate or modify the cells, and then re-inject them. Some manufacturers offer stem cell-based derived products, such as biologic eye drops made with placenta extract or amniotic fluid to treat dry eye. Clinics may provide misleading information and advertise their practice as running clinical trials. However, these clinics almost always work without FDA regulatory approval and outside of legitimate clinical trial approaches.

These unproven, unregulated stem cell treatments carry significant risk. The risks range from administration site reactions to dangerous adverse events. For example, injected cells can multiply into inappropriate cell types or even dangerous tumors. A 2017 report described one Florida clinic that blinded patients with stem cell eye injections.3

The Pew Charitable Trusts gathered 360 reports of adverse events related to unapproved stem cell therapies, including 20 cases that caused death.4 Further, adverse events are likely underreported because these products are not FDA approved or regulated. Many unproven stem cell-based therapies cost thousands of dollars to patients and are not covered by insurance. Further, even if patients avoid adverse events from these therapies, they may suffer consequences from delaying evidence-based treatments.

The FDA has made substantial progress toward regulation of stem cell-based therapies. In 2017, it released guidance under the 21st Century Cures Act that clarifies which stem-cell based therapies fall under FDA regulation. It also better defined how the agency will act against unsafe or unregulated products.5 As of May 2021, the FDA has more strongly enforced compliance for clinics that continue to market unproven treatments.6

Despite this increased regulation, rogue clinics are still relatively commonplace. A 2021 study estimated that there are over 2,500 U.S. clinics selling unproven stem cell treatments.7Patients at these clinics are often led to believe that treatments are either approved by the FDA, registered with the FDA, or do not require FDA approval. It is important to recognize that there are limits to the FDAs expanded reach, especially when it is targeting hundreds of clinics at once. Our clinic at Stanford recently cared for a patient who had received stem cell injections behind his eyes, where he developed tumors that ultimately ruined vision in both eyes.

Progress in stem cell science is rapidly translating to the clinic, but it is not yet the miracle answer we envision. With time, stem cell-based therapies will likely expand treatment options. People considering a stem-cell based therapy should find out if a treatment is FDA-approved or being studied under an FDA-approved clinical investigation plan. This is called an Investigational New Drug Application. Importantly, being registered with ClinicalTrials.gov does not mean that a therapy or clinical study has been authorized or reviewed by the FDA. For more information about stem cell therapies, visit http://www.closerlookatstemcells.org, a resource from the International Society for Stem Cell Research.

As we look hopefully to the future, we need greater awareness of the current limitations of stem cell therapy and the dangers posed by unregulated stem cell clinics. Strong FDA regulation and oversight are important for ensuring that stem cell-based therapies are safe and effective for patients. Accurate communication to the public, careful advocacy by physicians, and education of patients all continue to be crucial.

References:

1 U.S. Food and Drug Administration, Approved Cellular and Gene Therapy Products, Sept. 9, 2022,https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.

2 Stern JH, Tian Y, Funderburgh J, Pellegrini G, Zhang K, Goldberg JL, Ali RR, Young M, Xie Y, Temple S. Regenerating Eye Tissues to Preserve and Restore Vision. Cell Stem Cell. 2018 Sep 6;23(3):453. doi: 10.1016/j.stem.2018.08.014. Erratum for: Cell Stem Cell. 2018 Jun 1;22(6):834-849. PMID: 30193132.

3 Kuriyan AE, Albini TA, Townsend JH, Rodriguez M, Pandya HK, Leonard RE 2nd, Parrott MB, Rosenfeld PJ, Flynn HW Jr, Goldberg JL. Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD. N Engl J Med. 2017 Mar 16;376(11):1047-1053. doi: 10.1056/NEJMoa1609583. PMID: 28296617; PMCID: PMC5551890.

4 The Pew Charitable Trusts, Harms Linked to Unapproved Stem Cell Interventions Highlight Need for Greater FDA Enforcement, June 1, 2021,https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/06/harms-linked-to-unapproved-stem-cell-interventions-highlight-need-for-greater-fda-enforcement.

5 U.S. Food and Drug Administration, FDA announces comprehensive regenerative medicine policy framework, Feb. 2, 2022,https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework.

6 U.S. Food and Drug Administration, FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products, July 7, 2020,https://www.fda.gov/news-events/press-announcements/fda-extends-enforcement-discretion-policy-certain-regenerative-medicine-products.

7Turner L. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Cell Stem Cell. 2021 Nov 4;28(11):1891-1895. doi: 10.1016/j.stem.2021.10.008. PMID: 34739831.

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Putting Stem Cell-Based Therapies in Context | National Institutes of ...

Biotherapeutics

January 29, 2022

2021 has been a year of significant innovation across the field of regenerative medicine at Mayo Clinic. Important advancements in preclinical research, as well as new regenerative treatments for patients, further are solidifying Mayo Clinics reputation as a world-class leader in regenerative medicine.

Regenerative medicine is still a relatively new field of practice, representing a paradigm shift from the traditional focus of health care of fighting disease to rebuilding health. Mayo Clinic's Center for Regenerative Medicine is leveraging its unique expertise, resources and capabilities to create the worlds most advanced and innovative ecosystem for the development, manufacture and delivery of novel regenerative biotherapeutics.

New directions in biomanufacturing

Mayo Clinic is focused on a newly refreshed strategy in regenerative medicine this year one that emphasizes an enhanced capability for biomanufacturing, with technology platforms supporting the development of new therapeutics known as biologics. Biologics are a new type of "drug" derived from living organisms that have the potential for targeted healing with fewer side effects. Many of these next-generation therapeutics can be scaled and mass produced for patients at Mayo Clinic and around the world. The Center for Regenerative Medicine is leading Mayos enterprise biomanufacturing strategy in close collaboration with Research, Practice and Education leaders and key stakeholders, including theCancer Center,Center for Individualized Medicine,Department of Laboratory Medicine and Pathology,Mayo Clinic Ventures, Mayo ClinicPlatform,Center for Digital Healthand Mayo ClinicInternational.

In August, Mayo welcomed Julie Allickson, Ph.D., as the Michael S. and Mary Sue Shannon Family Director of Mayo Clinic's Center for Regenerative Medicine and the Otto Bremer Trust director of Biomanufacturing and Product Development in the Center for Regenerative Medicine, and she will lead the execution of Mayos biomanufacturing strategy. Dr. Allickson joined Mayo Clinic from the Institute for Regenerative Medicine at Wake Forest School of Medicine in North Carolina.

"This is an exciting time in regenerative medicine, a new era with great promise for the impact that these new therapies and procedures can have for patients," says Dr. Allickson. "I am looking forward to working collaboratively with colleagues across the enterprise to position Mayo Clinic as the global leader in scientific discovery and clinical practice advancement in regenerative medicine."

Significant investments in biomanufacturing facilities continued this year with the buildout of current Good Manufacturing Practices facilities on all three Mayo campuses.These facilities meet strict quality controls and regulatory guidelines that are required for manufacturing new biologics. The long-term goal is to have these new types of healing solutions on-site where they can be used immediately for patients with unmet needs. Mayo will focus on biomanufacturing across seven prioritized technology platforms:

Research that advances the practice

From helping establish common terminology for regenerative medicine to discovering new ways of manufacturing cardiopoietic stem cells with heart healing potential for select patients with advanced heart failure, Mayo Clinic physicians and scientists have made significant advancements in the discovery-translation-application continuum in regenerative medicine. Examples include:

Difficult-to-treat, chronic wounds healed with normal scar-free skin in preclinical models after treatment with an acellular product discovered at Mayo Clinic. Derived from platelets, the purified exosomal product, known as PEP, was used to deliver healing messages into cells of animal models of ischemic wounds. In a groundbreaking study published in Theranostics, the Mayo Clinic research team documented restoration of skin integrity, hair follicles, sweat glands, skin oils and normal hydration.

A Mayo Clinic collaborative study documented a remote-controlled bronchoscope functioned like a GPS system, tracking hard-to-find lung masses and accurately biopsying them. This multisite research, published in Annals of Thoracic Surgery, lays the foundation for precisely finding early stage cancer when it is most treatable, and targeting it with regenerative biotherapeutics needed to stimulate healing.

"In the past, we didn't have a reliable way of reaching these nodules in the lungs from within the airway. This is a very small catheter that gets almost anywhere, and is able to access and biopsy lung nodules," says Janani Reisenauer, M.D., first author on the study and a Mayo Clinic thoracic surgeon. "It's very similar to driving a car and having your normal street view with the aid of the GPS in your car telling you in real-time where to turn right and left to arrive at your destination."

Mayo Clinic researchers biomanufactured chimeric antigen receptor-T cell therapy (CAR-T cell therapy) in a new way to track the cells' cancer fighting journey and predict toxic side effects. This Mayo Clinic breakthrough, published in Cancer Immunology Research, could make this immunotherapy easier for patients to tolerate. Perhaps more importantly, it could unravel the mystery of how to expand CAR-T cell therapy to more types of cancers.

"This new technology allows us to image CAR-T cells after they are given to patients and study their fate," says Saad Kenderian, M.B., Ch.B., a Mayo Clinic hematologist and researcher, and lead author. "This allows us to investigate strategies that could improve CAR-T cell trafficking and penetration into the tumor cells, and thus canimprove tumor killing."

Mayo Clinic is applying regenerative medicine to cosmetic services aimed at resetting the body's clock to a time of more youthful function and appearance. Regenerative procedures, such as platelet-rich plasma to rejuvenate aging skin and stimulate hair growth for people with alopecia or baldness, are offered on all three campuses. Many regenerative services go beyond cosmetics to facial reconstruction after disease, cancer or traumatic injury. For example, The Multidisciplinary Cosmetic Center at Mayo Clinic in Arizona pairs general and facial plastic surgery with dermatologists, gynecologists, vascular surgeons, urologists and aestheticists to deliver services grounded in scientific evidence and the latest regenerative technologies.

Training the emerging regenerative sciences workforce

A well-trained regenerative science workforce is needed to apply the newest discoveries to clinical care. Mayo Clinic has made significant strides this past year in educating future physicians, scientists and allied health staff in regenerative medicine.

Mayo Clinic achieved an important milestone when it admitted its first five students as inaugural scholars in the newly established Regenerative Sciences Track within the Ph.D. program in the Mayo Clinic Graduate School of Biomedical Sciences. The new doctoral program that began this fall fulfills Mayo's objective of providing first-of-its-kind education in the evolving field of regenerative science and medicine

Taught by regenerative science and medicine experts, the curriculum embraces a training paradigm that includes fundamental cellular and molecular science principles, and transdisciplinary education in regulatory issues, quality control, bio-business and entrepreneurial pathways, data science, medical sciences, ethics, and emerging technologies.

Throughout the four-day symposium, experts at Mayo Clinic and around the world shared regenerative medicine applications to aging, musculoskeletal conditions, lung diseases, organ transplantation and cancer. The symposium featured presentations on promising research, navigating regulatory pathways and seeking opportunities for commercialization.

Peter Marks, M.D., Ph.D.,director of the Food and Drug Administration (FDA) Center for Biologics Evaluation made a virtual presentation where he pledged FDA support for regenerative technologies that offer new solutions for unmet patient needs.

Another promising year in 2022

Mayo Clinic in Arizona is among the first to offer larynx transplantation and is currently evaluating patients for this landmark surgery. In addition, Center for Regenerative Medicine continues to support initiatives, such as expanding of CAR-T therapy and making organ transplantation more available and successful for patients.

New advanced biomanufacturing facilities will be operational in One Discovery Square in Rochester and in the Discovery & Innovation Building in Florida. Biomanufacturing expansion on the Phoenix campus will be strategically assessed as the buildout of Arizona "Bold. Forward" continues. The Center for Regenerative Medicine continues to spur innovation to rapidly advance novel regenerative therapies into the clinic to support Mayo Clinic's 2030 Vision to cure, connect and transform care.

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Science Saturday: A year of new directions and advancements for ...

Veterinary Medicine in the Digital Age  Boehringer Ingelheim

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Veterinary Medicine in the Digital Age - Boehringer Ingelheim

MU Researchers Participating in International Clinical Study Targeting Prevention of Osteoarthritis  University of Missouri School of Medicine

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MU Researchers Participating in International Clinical Study Targeting Prevention of Osteoarthritis - University of Missouri School of Medicine

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Penn Medicine Accelerator Program to Boost AI-Powered Projects Targeting Blindness and Cervical Cancer - India Education Diary

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ROSM Celebrates 10 Years of Advancing Patient Care Through Regenerative Medicine - goskagit.com

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Not too late to repair: gene therapy improves advanced heart failure in animal model - Baylor College of Medicine | BCM

How does waste leave the brain? Washington University School of Medicine in St. Louis  Washington University School of Medicine in St. Louis

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How does waste leave the brain? Washington University School of Medicine in St. Louis - Washington University School of Medicine in St. Louis

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Investigating Maternal Inflammatory Arthritis and Pregnancy Outcomes < Yale School of Medicine - Yale School of Medicine

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Flea, Tick, And Heartworm Products Global Market Report 2024: Evolving Veterinary Medicine Drives Innovation in Pet ... - PR Newswire

Precision Medicine's Breakout Year: 2024 Trends  Pharmaceutical Executive

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Precision Medicine's Breakout Year: 2024 Trends - Pharmaceutical Executive

Scientists Find Key To Potential Breast Cancer Prevention, Treatment | Newsroom  UNC Health and UNC School of Medicine

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Scientists Find Key To Potential Breast Cancer Prevention, Treatment | Newsroom - UNC Health and UNC School of Medicine

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8 Eye Issues You Should Never Ignore - Right as Rain by UW Medicine

What is Integrative Medicine?

Integrative medicine (IM) is an emerging field that emphasizes the evidence-basedcombination of both conventional and alternative approaches to address the biological, psychological, social and spiritual aspects of health and illness.

Integrative Medicine practitioners usually take a holistic/total person approach to their patients. They understand that overall health and well-being is a combination of multiple factors, including genetics, physiology, the environment, personal relationships, health beliefs, and the power of a positive medical interaction. In some situations, Integrative Medicine modalities may achieve similar results to conventional medicine with fewer side effects, and may create a greater sense of individual self-efficacy.

Stanford contains an Integrative Medicine Center; hospital-wide functions such as massage and pet therapy; various clinic-specific programs; educators and researchers exploring integrative medicine; and individual practitioners who may be either trained in, or knowledgeable about and open to, various modalities.

The purpose of this website is to gather together in one place an easily accessible snapshot of where to find Integrative Medicine modalities and practitioners/researchers/educators at Stanford Medical Center. It will be regularly updated. If you find something missing, please contact the webmaster.

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Integrative Medicine | Stanford Medicine

Integrative Medicine Approach to Reducing Risk of Chronic and Autoimmune Diseases  WholeFoods Magazine

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Integrative Medicine Approach to Reducing Risk of Chronic and Autoimmune Diseases - WholeFoods Magazine

Helen Mongelia's 102 years reflect the mysterious alchemy of genetic, environmental, and lifestyle factors that coalesce to aid longevity. Fresh food, consistent movement, emotional resilience, and a family full of long-living relatives mark the centenarian's colorful life span, which began in 1919 while Woodrow Wilson occupied the White House.

Longevity like Mrs. Mongelia's remains extraordinary, with an estimated one in 6,000 people in the United States reaching 100 nowadays, according to the U.S. Administration on Aging. More than 100,000 were 100 or older in 2019, triple the number in 1980 who'd passed their 100th birthday.

Scientists, including those at Harvard, are eagerly studying people in their 90s and beyond to tease out what contributes to exceptionally long living. People enduring to extreme old age often have lifestyles that fuel vigor and hamper age-related chronic diseases such as heart disease, cancer, and diabetes. They typically are nonsmokers, are not obese, and cope effectively with stress, according to the National Institutes of Health (NIH). Most are women.

"I didn't expect to live this long, that's for sure," says Mrs. Mongelia, who lived independently until 101 when she also gave up driving and happily holds a mailroom job at her assisted living residence in Connecticut. "But I've tried not to let anything bother me too much. I have two great daughters, two sons-in-law, and two grandchildren what else can you ask for? There's my happiness right there."

Mrs. Mongelia never restricted her diet, eating meat but skipping most alcoholic drinks. But her early fare as the middle child of 11 was abundant in fruits and vegetables, many grown in her family's garden in Carbondale, Pa., and canned to enjoy all year long. The large clan also walked "everywhere," trekking miles round-trip to church, school, and the grocery store.

Mrs. Mongelia's healthy habits hit a sweet spot that science increasingly spotlights as optimal for longevity. A new Harvard-led study spanning 11 years and involving 2,400 people (average age 60; 55% women) suggests that a Mediterranean diet rich in fruits, vegetables, and healthy fats may dampen inflammation and prevent age-related frailty, a major predictor of decline affecting between 10% and 15% of older adults.

"Frailty is hard to define, but it's really easy to spot. In general, it's a state of increased vulnerability," says Courtney Millar, a postdoctoral research fellow at the Marcus Institute for Aging Research at Harvard-affiliated Beth Israel Deaconess Medical Center.

"It's important to focus on frailty prevention and treatment, because it's associated with so many of the factors that determine someone's longevity," says Millar, a co-author of the study, published online May 12, 2022, by The American Journal of Clinical Nutrition.

Another new study suggests that young adults who begin optimizing their diets at age 20 by veering from typical Western fare to more whole grains, legumes, and nuts could increase their life expectancy by more than a decade. Published online Feb. 8, 2022, by PLOS Medicine, the study posited that people who start such dietary shifts even at age 60 can still reap substantial benefits, increasing life expectancy by eight years for women; 80-year-olds could gain another three-plus years.

"I'm certainly a believer that food is medicine," Millar says, "and there's some great evidence that dietary factors can improve longevity."

Mrs. Mongelia's family is peppered with relatives who've had far longer-than-average life spans. Although her coal miner father died of black lung disease at 78, Mrs. Mongelia's mother lived to 93, and many siblings also thrived into their 10th decade. Two brothers still survive.

Research reinforces this link: siblings and children of long-living people are more likely to live beyond peers and remain healthier while doing so, according to the NIH. A study published online May 28, 2022, by The Journals of Gerontology, Series A: Biological Sciences and Medical Sciences suggested that children of those who reach 100 carry a specific "genetic footprint" explaining why they're less frail than peers whose parents were not centenarians.

Might our genes be the linchpin to longevity? "My take is that it's certainly a combination of lifestyle and genetics," Millar says. "Certain dietary factors and even exercise regimens can modify how our genes are expressed and contribute to what's going on in our bodies. It's a really important intersection of our health."

Some scientists use the term "biohacks" to refer to tweaks in daily habits and choices that aim to tamp down inflammation and blunt aging's effects. Many of these tactics aren't new, but Harvard experts say that employing them consistently might contribute to longevity.

Move more. Vigorous movement has repeatedly been linked with lower risks of heart disease, diabetes, obesity, and other chronic health problems.

Review your health history. Talk to your primary care doctor about your health conditions and any new symptoms so you can manage them appropriately.

Try intermittent fasting. Compressing meals into a six- or eight-hour window each day boosts the body's natural process of eliminating damaged cells and proteins, lowering inflammation levels.

Eat a plant-forward diet. Antioxidants from fruits and vegetables and fiber from whole grains all help to lower inflammation levels. Beans, chickpeas, and other legumes were hailed as a key dietary predictor of longevity in a study that found a daily dietary increase of just 20 grams (less than an ounce) of legumes lowers our risk of dying in any given year by 8%.

Boost your outlook. List your life goals and imagine a future where they've been reached, or think about three good things that happened to you every day. Write them down.

Despite a hardscrabble path that included dropping out of school after 11th grade to take care of a baby sibling and also working as a button operator in a dress factory where she earned three cents per dozen buttons mounted Mrs. Mongelia maintains an upbeat attitude that matches her hardy body. She relies on a walker and hearing aids, but remains mentally sharp. "Just keep going and going and going, and don't give up," she counsels.

A recent Harvard-led analysis of nearly 160,000 American women linked positive outlook to extended life span. Published online June 8, 2022, by the Journal of the American Geriatrics Society, the study analyzed data and survey responses from women who were 50 to 79 years old when they enrolled in the study in the 1990s. The researchers then tracked participants' survival for up to 26 years. The results suggested that higher levels of optimism correlated with higher odds of living beyond 90.

About a quarter of the relationship between optimism and living longer may reflect health-related factors such as eating healthy foods, controlling weight, exercising, and limiting alcohol, says study co-author Dr. Hayami Koga, a researcher and doctoral candidate in population health sciences at the Harvard T.H. Chan School of Public Health.

The findings hint at the value of focusing on positive psychological factors as possible new ways of promoting longevity and healthy aging, Dr. Koga says. "There's some evidence that optimistic people are more likely to have goals and the confidence to reach them," she adds. "I think it drives people to be more confident and take actions that lead to better health."

Photo by Timothy H. Cole

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Aiming for longevity - Harvard Health

Clues to preventing Alzheimer's come from patient who, despite genetics, evaded disease Washington University ...  Washington University School of Medicine in St. Louis

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Clues to preventing Alzheimer's come from patient who, despite genetics, evaded disease Washington University ... - Washington University School of...

Association of genetic risk and lifestyle with pancreatic cancer and their age dependency: a large prospective cohort ...  BMC Medicine

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Association of genetic risk and lifestyle with pancreatic cancer and their age dependency: a large prospective cohort ... - BMC Medicine