Stem Cell Therapy is a hot topic in the news. With all the varying perspectives, information, and misinformation, combined with an influx of stem cell clinics, sorting out this large volume of information is difficult, even for medical professionals.
Cellular therapies and their use in regenerative medicine hold almost infinite possibilities for curative treatments. Scientific advances in the understanding of how the body actually heals through tissue regeneration, combined with rapid developments in stem cell biology, have truly created a renaissance in medical treatment. However, Regenerative Medicine remains in its early stages and its use has grown with little regulation. The FDA is currently addressing several key issues to ensure legitimate medical use:
- Claims of effectiveness
- Viability of source and processing methods
- Clinical studies to ensure effectiveness
- Qualification of professionals performing the procedure
As this developing field continues to mature, a small number of clinics have attached a “stem cell” label to products and procedures that do not actually contain live stem cells. Using overstated or false claims enables disreputable clinics to easily exploit desperate patients. These unscrupulous clinics stand in the way of sincere efforts to discover and provide treatments for conditions that previously had few options.
Role of the FDA
The FDA has recently taken aggressive steps toward regulation of stem cell use and production, issuing injunctions against clinics in Florida and California after patients were blinded by injection of stem cells into the eye. Previous warnings had been issued to these clinics in August of 2017 regarding their unethical practices and unsubstantiated claims. In March 2018, these clinics were closed.
FDA regulations specify that cells used for regenerative purposes must meet the following standards:
- Minimal manipulation
- Homologous use, meaning the repair of recipient’s tissue that performs the same basic function of tissue from the donor
When cells fail to meet these FDA requirements limiting alteration of the source cells, they are labeled as a drug product subject to FDA approval.
Hundreds of clinics have opened around the county making unproven claims. Labeling of amniotic tissue as “stem cell therapy” is a primary concern in Regenerative Orthopedics for physicians trained and certified in cellular biological use of stem cells. Although this tissue contains growth factors that have been shown to accelerate and enhance healing, they do not contain live stem cells.
Qualifications of professionals administering “stem cell therapy” is sometimes questionable. Although the treatment given may be beneficial, the labeling is deceptive and inaccurate. Patients are left with failed expectations which taint more legitimate procedures.
Scott Gottlieb, M.D., FDA Commissioner, expresses his perspective:
"From my standpoint, this is a field where there’s a lot of medical promise, but we also see bad actors putting people at risk, harming patients and peddling false hope."
The majority of physicians and researchers welcome strong intervention by the FDA. Regulation of medical claims, oversight of processing, and clinical studies showing effectiveness of treatment are all vital to the healthy growth of biocellular medicine.
Because of the tremendous medical potential of regenerative medicine, the FDA has provided an accelerated route to FDA approval of various methods of administering these life-changing cells.
"One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality." Scott Gottlieb, MD, FDA Commissioner
Bone marrow stem cells
Bone marrow transplants have been used for many years to treat blood diseases. Haematopoietic stem cells (HSCs), produced in the marrow are responsible for maintaining blood production throughout our lives, including cells needed for the immune system. Discovered in the 1960s, they are the first stem cells scientists recognized.
A second type of stem cell found in bone marrow is the mesenchymal stem cell (MSC). These cells have the potential to develop into bone, cartilage, and soft tissues of the musculoskeletal system, making them a natural enhancement to healing of joint injury and arthritis. Tissue surrounding joints traditionally heals slowly and often incompletely due to poor blood supply. Localized stem cells that normally repair damaged tissue often becomes depleted due by chronic injury or simply by the aging process. These factors often cause the body to need help in repairing tissue.
Bone marrow stem cells (BMSCs) are the only stem cell-based products FDA approved for use in the US, meeting standards of minimal manipulation and homologous use. Cells are harvested from the patient’s hip, minimally processed on site and injected into the site of injury. These viable stem cells differentiate into cells of target tissue and integrate into this tissue, regenerating tissue to replace necrotic, or damaged, cells. Physicians may use a booster of Platelet Rich Plasma, PRP, in the solution itself to provide growth factors and nutrients helpful in the healing process.
Degeneration of tissue from osteoarthritis and rheumatoid arthritis can often be reduced and growth of new cartilage stimulated through the use of BMSCs, which can prevent or delay surgical joint replacement.
Studies related to use of stem cells found in umbilical fluid, USCs, cells are primary in relation to musculoskeletal conditions. In addition to stem cells, this fluid is rich in nutrients and growth factors that play a key role in repair of tissue damage.
A key issue with use of umbilical cord stem cells, however, is the lack of clinical research and standardization of processing methods. Popularity of their use increased despite little regulation regarding processing methods and viability of source. Little data exists regarding their effectiveness. In short, research has not kept pace with medical use. Controlled clinical studies in humans are needed and have been a primary subject for the past several years.
FDA commissioners Peter Marks, M.D., Ph.D., and Scott Gottlieb, M.D., recently issued a series of statements regarding the FDA position on the use of autologous stem cells, or stem cells derived from a source other than the patient’s own body. In the most recent publication, “Balancing Safety and Innovation for Cell-Based Regenerative Medicine,” published in the New England Journal of Medicine (NEJM), the FDA establishes oversight to a stem cell industry that has grown with little regulation.
Recognizing the tremendous potential of regenerative medicine, the publication also presents a new regulatory pathway, or fast track, for clinical studies to expedite controlled development of stem cell therapies for legitimate professionals in FDA accepted clinical studies. "Our aim is to refashion our traditional tools for regulation to meet the challenges and opportunities presented by such highly innovative products as cell-based regenerative medicine..."
The new FDA guidelines provide a fast track for clinical trials allowing individual physicians and small groups to submit data to be compiled in collaboration to support effectiveness of a regenerative medicine product. A 36-month timeframe has been given for development and completion of these clinical studies.
"For example, the FDA will provide tools to encourage individual or small groups of physicians to collaborate in support of the development of a stem-cell or other regenerative medicine product, which will ultimately lead to the receipt of a biologics license by each of the physicians or groups... " P Marks and S. Gottlieb
"The investigators who manufacture the product will need to agree on and follow a common manufacturing protocol and develop a common clinical trial protocol. Each site will then produce the product to treat the patients who are enrolled in the clinical trial at its own site. Subsequently, the pooled safety and efficacy data from the various sites that are participating in the trial will be submitted as part of a biologics license application for each."
Stem cell treatment today
Bone Marrow Aspirate Concentrate is currently an approved medical treatment using your own natural healing properties. Currently, FDA approved bone-marrow derived MSCs are an excellent option for treatment of acute and chronic musculoskeletal conditions. BMAC meets 361 FDA Guideline Criteria by being minimally manipulated, homologous use, not combined with other ingredients, and no systemic effect.
About Dr. Minotti
I am Dr. Minotti, a Regenerative Medicine specialist. I have spent the past 18 years exploring and researching new and better ways to treat the body naturally. I help frustrated patients find freedom from pain and restore their quality of life so they can do the things they love.
Regenerative Medicine helps bodies mend themselves, providing cures for people who have been living, until now, without treatment options. Previously, the primary treatment options for musculoskeletal pain included drugs to mask pain or surgery that cuts and sews. Regenerative Orthopedics effectively bridges this gap, offering an option for the majority of musculoskeletal injuries. Studies show that 86% of acute and chronic musculoskeletal injuries can be healed without the use of surgery.
Regenerative Medicine is changing healthcare by providing physicians with new procedures that enhance the body’s natural ability to heal itself. Healthcare is no longer merely the treatment of disease. We all want to live longer, live better, and live healthier. We no longer want medications that treat pain but mask injury or procedures that cut and sew.
As scientists learn more about the physiology of how our bodies heal, healthcare can provide new and better treatment of musculoskeletal conditions, treatments that help our bodies heal the way they heal naturally.
Regenerative Orthopedics is radically changing the way musculoskeletal conditions are treated. I have done thousands of procedures that treat musculoskeletal health. I would like to help you.
Please call us at 361.343.7014 to learn more about how we can help you.
Natural forces within us are the true healers of disease. ―Hippocrates