How the FDA’s Stem Cell Crackdown Hurts Patients

The Food and Drug Administration of the United States (FDA) is involved in the analyzing, research and development, and eventual approval of the various medications that may be offered to patients within the United States. To date, the FDA has shown some interest in stem cell therapies, and it is no wonder why: as one of the newer players into the field of medicine, stem cell research and development is trending towards possible treatment options for a wide variety of chronic, debilitating conditions. There are thousands of people with these conditions in the United States that are currently receiving their treatment through stem cell clinics. However,  there is only one particular treatment that involves regenerative medicine that has been officially approved– and as time goes on, the FDA is increasing regulation against regenerative medicine practitioners throughout the country. 

The Food and Drug Administration of the United States (FDA) (Photo By Al Drago/CQ Roll Call)

FDA and Stem Cells

It is a well-known fact among medical professionals that modern medicine has largely been focused on curbing the symptoms and malaise that come with illness, and all too often there are many conditions that are chronic, and there are no treatment plans available for them. However, as stem cell research continues to encounter new breakthroughs month after month, more and more conditions are being revealed to benefit from these therapies in unprecedented ways. 

In their attempt to legislate stem cell therapies, however, the FDA has taken some legal steps to curb the proliferation and activity of stem cell clinics throughout the United States. These clinics, many of which provide valuable services and treatment options for people with a variety of chronic conditions including Alzheimer’s, leukemia, MS, and autism, are being brought under fire because of what the FDA calls false advertising– and in some cases, this is true. No field is full of completely good actors, and some regenerative medicine practitioners advertise to be able to treat conditions that stem cells are not able to– because of this, appropriate legal steps have been taken to stop the clinics spreading misinformation.

One of the grievances that stem cell clinics– especially those who have been conducting the research required to provide efficacious treatments to their patients– have against this legislation is that there is no real authority that the FDA possesses over stem cell clinics. This is because what they offer is an operation– a surgery. Although it uses stem cells, these cells are most often harvested from the patient’s own body, which should not qualify it as a drug. Because of this, people are attempting to push back against this FDA decision, but it is difficult for small businesses to do so.

How Can Stem Cell Clinics Survive? 

However, the FDA’s more indiscriminate legislature is creating problems for those stem cell clinics that are offering regenerative medicine therapies that actually benefit those receiving them. In an effort to curb unsafe practices, they have made it nearly impossible for stem cell clinics to be able to operate in the United States in the future. This is a problem for those who practice in these clinics, of course, but the majority of them are medical professionals who can almost certainly find employment elsewhere– however, there are thousands of patients in the United States who rely on stem cell clinics and the regenerative medicine therapies that they offer to manage the symptoms of their chronic diseases. For these people, it will not be as easy as finding another job, and they are left scratching their heads in regards to how to continue their treatment. 

Put simply, if the FDA continues to create miles of legislative red tape, if it continues to create expensive, time consuming hurdles for stem cell clinics to jump through, there will be fewer and fewer places to receive these treatments in the United States, and people will have to go to other places to obtain the therapies that benefited them. 

How Medical Tourism is Helping Patients 

In the field of regenerative medicine, there have been many entrepreneurial practitioners who have decided to open companies that provide these services– something known as medical tourism. In the past, medical tourism has had a reputation for being largely for people from less developed countries to travel overseas for complicated procedures that have not been able to find in their own home– but now, especially as the cost for medical procedures in countries like the United States go up, many people from highly developed countries like it are instead looking for countries that offer procedures ranging from surgery to regenerative medicine therapies. 

One such company is the Cellular Hope Institute, which has been providing such a service for the last eight years. A subsidiary of Global Stem Cells Group, the Cellular Hope Institute has partnered with the Amerimed Hospital in Cancun– this is a full, state of the art hospital which is accredited by both the Mexican General Health Council and the Canadian Accreditation Council. Amerimed is staffed by a qualified team of physicians whose specialties range from pediatricians, radiologists, neurologists, anesthesiologists,  and regenerative medicine specialists. 

Every day, the Cellular Hope Institute evaluates, diagnoses, and treats patients from all over the world who suffer a wide variety of medical conditions. We treat them with the most advanced, peer-reviewed regenerative medicine technology and therapies in order to lessen their symptoms and increase their quality of life. We also provide a pathway for patients to directly contact us– through this, we can open up the dialogue required to devise a treatment plan for them. The Institute’s facilities are top-notch, and include a laboratory to culture-expand cells, a process that yields far better patient results (and is currently not allowed by the FDA), and a cryopreservation unit to keep extracted samples stored safely until they are needed. 

The needs and conditions of each patient are unique and different, and over our years of experience we’ve developed treatment protocols for a wide variety of patients. The advancement of stem cell therapy has propelled it in the last decades from treating lymphoma and leukemia to showing promise in the treatment of over 70 different diseases and conditions that may otherwise have a significant impact on the human body. Over the years we have treated thousands of customers– we’ve been able to circumvent miles of red 

Our facilities in Cancun are top-notch, and include a laboratory to culture-expand cells, a process that yields better patient results, and a cryopreservation unit to keep these extracted samples stored safely until they are needed. Each patient’s needs and health issues are unique. We’ve taken this unique set of needs into consideration, and daily evaluate, diagnose and treat patients from all over the world with the most advanced regenerative medicine technology available today. 

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