Stem Cells have been a controversial cure for many decades.
They have offered promises to cure incurable diseases. It’s true that there is legitimate scientific evidence that shows stem cells are used to replace cells damaged by disease and or chemotherapy.
Stem cells have the ability to morph into many different types of cells. They are precursor cells and have the capacity to self-renew and regenerate multiple cells. Described as the “body’s repair system,” these cells could hold the key to curing unlimited disease processes.
The Reprograming Of Cells
The term ‘stem cell’ was first coined in scientific literature by German biologist Ernest Heckel in 1868 to describe how a fertilized egg becomes an embryo. Scientists first discovered how to extract these cells from mouse embryos in 1981. In 2006, scientists discovered certain types of adult cells “reprogrammed” genetically to assume a stem cell like shape.
Stem cells exist in both embryos and adult cells. There are two major classes of stem cells: pluripotent, that can become any cell in the adult body, and multipotent, that are restricted to becoming a more limited population of cells. Stem cells have the ability to build every tissue in the body. Although they are proving to be impressive game changers in medicine, especially in the areas of regenerative medicine and transplantation, not all stem cell treatments are FDA approved. Unfortunately, there are practitioners using stem cells on patients that have been unapproved and unproven.
COVID-19 Cure Claims
A 65-year-old woman in China who was critically ill in the ICU (intensive care unit) with COVID-19 received a stem cell transplant from the umbilical cords of newborn babies. In only four days she was able to be on her feet and walk around. The doctors at the hospital in China proved that stem cells were able to cure patients in only three days.
It’s believed that stem cells can regenerate lung tissue that has been destroyed by COVID-19. Mesenchymal stem cells appear to be a promising cell therapy given that they favorably modulate the immune response to reduce lung injury. The use of exogenous stem cells may lead to lung repair.
The US Food And Drug Administration recently approved a phase of a 1/2a trial assessing the use of umbilical cord mesenchymal stem cells for treating patients with severe COVID-19. Critically ill patients are now being registered for clinical trials. Cedars-Sinai Medical Center recently cited studies that “support the notion that cell therapy can attenuate inflammation, which may be attractive in COVID-19.” One study by an international coalition of researchers from China, United States, India, France, and other countries appeared in Aging and Disease, showing full recovery of seven COVID-19 patients 2 weeks after receiving intravenous (IV) administration of allogeneic (sourced externally from donors) MSCs.
Unfortunately, there are many companies pushing stem cell therapies as a treatment and a cure for COVID-19. These stem cell companies have not been FDA approved nor have the stem cell therapies been adequately tested in clinical trials except for the mesenchymal stem cell study as quoted above.
FDA Approvals And Warnings
The FDA has approved stem cells for treatment of blood cancers and immune disorders. The only products that are approved by the FDA in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. Stem cells are being offered by a variety of healthcare providers as a treatment to various ailments with claims of being able to cure many different ailments. These claims are currently not proven and must undergo the appropriate clinical trials. Such products must also go through the FDA review process.
Per the FDA here are the adverse effects that can occur if obtaining unapproved stem cell therapy:
- Administration site reactions,
- The ability of cells to move from placement sites and change into inappropriate cell types or multiply,
- Failure of cells to work as expected, and
- The growth of tumors.
In 2018, several patients in the United States became and ill and were hospitalized after receiving non-FDA approved cells processed from Genetech, Inc., and distributed by Liveyon. The CDC tested unopened vials of the stem cells and found that they were contaminated with E. coli bacteria.
Clinics may make claims that such cells are a ‘miracle cure,’ that can cure multiple diseases like musculoskeletal (chronic joint pain, and injury related pain), neurologic, cardiac, diabetes, Parkinson’s, Alzheimer’s, COPD, and many more. Some taunt that they offer ‘Mercedes’ type stem cell treatments at the price of a’ Ford.’ Although these claims can seem enticing to a vulnerable population seeking a treatment for a debilitating disease process, both healthcare practitioners and patients need to do their homework before procuring a stem cell treatment.
Some clinics may falsely advertise that it is not necessary for the FDA to review and approve their stem cell therapies. They may claim that their registration with the FDA or an FDA inspection equates to FDA approval or a form of FDA endorsement. These claims are false.
The best thing for patients to do is seek out a clinical trial using stem cells for their disease process. It’s best to have the clinic, healthcare practitioner and cell therapy fully vetted and researched before obtaining any kind of treatment. Patients should also ask clinics for their FDA documentation of a trial under an active new drug application, also known as an IND.