A federal judge recently ruled in favor of a regenerative medicine clinic against the FDA
The FDA brought the lawsuit against Cell Surgical Network Clinic in 2018 in an attempt to assert regulatory authority over stem cell therapies. The agency argued that a physician’s use of his patient’s own stem cells as part of the medical treatment provided to the patient was equivalent to manufacturing a biological drug product and therefore subject to regulation by the FDA.
The court rejected this argument on Tuesday, ruling that the surgical procedure does not create a new prescription drug. The court wrote: “The adipose tissue Defendants remove from patients clearly consists of human cells. And whatever is injected back into patients as part of Defendants’ SVF Surgical Procedure and Expanded MSC Surgical Procedure certainly contains such cells.”
This news opens up the possibilities and sets an important precedent for clinics in the United States to use autologous cellular treatments derived from adipose tissue, giving patients the right to use their own tissue to enhance regenerative processes and fight disease.
“We appreciate the Court’s clear and unequivocal ruling, which affirms what we have been saying for 12 years: that our innovative surgical approach to personal cell therapy is safe and legal,” said Dr. Elliott Lander, co-founder of CSCTC. “With this victory behind us, we look forward to refocusing our energy on our practice and leveraging life-changing stem cell treatments to support physicians and benefit patients across the country.”
As science advances, it’s inevitable that there will be more diverse forms of treatment with human stem cells. Whether the FDA gets on board and expands its rules about what is and is not legal is another question.
Unfortunately, much of what the FDA does falls into the category of politics. It’s usually unwise to make a decision about a particular kind of therapy or medical treatment based on whether it’s technically, currently legal.
It’s helpful to recall that many treatments that are fully legal began as experimental procedures that were not legally offered to the public but only took place in controlled research environments.
The good news is that stem cell therapy continues to make rapid advances on several different fronts, primarily those related to joint pain and associated discomfort. Athletes have made good use of the treatment and were, in fact, among the first major wave of clients for the technique when it was still brand new. After that, word spread about the effectiveness of stem cell treatment as more and more people turned to it as an alternative to surgery and prescription medication.
- Published in News
The FDA Vs Stem Cell Treatments In The US
Stem cell therapy has become a popular type of treatment for a number of conditions, including to assist in the regeneration of injured tissue or diseases cells in the human body. This therapy is classified as regenerative medicine. Several advancements have already been made in this medical field, and many had experienced positive results when they underwent stem cell therapy to assist in the treatment of degenerative conditions.
While stem cell therapy has been proven to provide an effective protocol in the recovery of stroke, neurological issues, and even to assist in repairing the damage that was dealt by a heart attack, recent reports have caused many to view these treatments in a negative perspective. This is due to the warnings that were recently issued by the FDA. Even though some have experienced side-effects due to the use of stem cell therapy, it is important to note that there are facilities within the US that can provide professional services that help to minimize the risk of these adverse events.
The FDA On Stem Cell Therapy In The United States
The Food and Drug Administration of the United States is involved in the analyzing and approval of medications and medical procedures that may be offered to patients in the country. To date, the FDA has shown some interest in stem cell therapy, providing approval for several clinical trials that looked at how effective this treatment is in providing a regenerating effect on the impact that certain conditions has in the human body. Only one particular treatment that involves stem cell therapy has been officially approved by the Food and Drug Administration, however.
Within the last few months, we have seen several concerning publications made by the FDA regarding stem cell therapies, reducing the hope that some patients might have gained.
On the 25th of June, 2019, the FDA published a statement that described a permanent injunction that will occur with the many stem cell clinics in the country. The FDA has stated that the action taken from their side is to assist in providing a layer of protection for patients, due to the risks involved with undergoing treatments that utilize products that have not gone through any type of approval process.
The specific company that was targeted in this statement and by the actions that were taken by the FDA is known as US Stem Cell Clinic LLC. The court ruled in favor of the FDA and US government earlier in June, finding the defendants, being US Stem Cell Clinic LLC, guilty of the claims that were made against them.
An earlier publication also confirmed that the Federal court has decided to rule the misbranding of the stem cell products released by the US Stem Cell Clinics company as a violation of laws that have been implemented to protect the people of the country.
News publications have also announced that the regulations and guidelines that have now been set out by the FDA might cause a significant decline in the availability of stem cell treatments to patients in the United States. The companies that have been targeted through these particular actions that the FDA has taken are primarily those that have been marketing products that have not gone through approval phases – and these products have been found to put the patient’s health at risk.
The Role Of Stem Cell Therapy In Disease
While some companies have been found guilty of using unapproved and even misleading products on patients, promoted as stem cell therapy, it is important to consider the reality of the situation as well. Stem cell therapy often referred to simply as Cell therapy, has been proven as a successful regime in the treatment of several conditions. Many of the conditions that have shown improvement with the use of this therapy were previously considered difficult, or sometimes even impossible, to effectively treat.
By 2012, the Worldwide Network for Blood and Marrow Transplantation, also known as the WBMT, announced that a total of one million stem cell therapy procedures had been done throughout the world. This was a significant milestone, and these procedures have helped to save a countless number of lives. Just in this report, the WBMT refers back to a case of Marta, a girl from Madrid, who had received stem cell therapy at a young age. This treatment was provided to Marta after she was diagnosed with Leukemia. In 2002, Marta was able to overcome Leukemia, thanks to the cell therapy that was provided to her.
While lymphoma and leukemia are the conditions where patients most frequently seek a clinic that can perform stem cell therapy on them, there are many other conditions that are treated with this procedure today. The perfection of the therapy has led to a treatment that can assist in reducing the effects of over 70 diseases that may otherwise have a significant impact on the human body.
GSCG Expands To Cancun, Meets The Demands Of US Patients
The Global Stem Cells Group had recently announced the opening of a new office that they have decided to establish in Cancun, Mexico. The decision was driven by the increasing demand for cell therapy procedures by patients in the United States and by the fact that there is currently a lack of facilities that are able to provide these individuals with the professional and quality services needed. Doctors specializing in regenerative medicine are also having a hard time fulfilling the needs of patients who wish to consider cell therapy as a potential treatment option.
This is not the only local office that GSCG now operates in Cancun, as the company now has two facilities within this particular location. These offices include a stem cells laboratory, as well as a general medical facility.
Over the years, GSCG has become an established name in the stem cell field, providing thousands of doctors the opportunity to offer cell therapy as a treatment option for patients with degenerative diseases. The use of this therapy may assist in the regeneration of damaged and diseased tissues in the patient’s body.
Even though a previous office had established a presence for GSCG in Cancun, it should be noted that the company announced that the opening of the new office means they have now officially created a permanent presence for the brand in the area.
The GSCG’s new facility in Cancun is equipped with the latest advancements that have been made in the field and provide quality services that ensure patients have a trusted medical facility where their patients can undergo cell therapy as part of a regenerative medicine treatment plan.
At the moment, doctors who are in the field of regenerative medicine within the United States can turn to this facility to offer their patients an additional treatment option, apart from the standard pharmaceutical protocols that have been established. The stem cell laboratory can assist in the analyzing of patient data and also in the process of finding a matching donor for the person who is in need of stem cell treatment.
GSCG’s facility is able to assist with the culturing of expanded autonomous cells, as well as other types of cells that may be utilized in the process of stem cell therapy. A detailed approach is taken, considering the age of the donor, as this would also provide an overview of the autonomous stem cell age. The patient being treated is also taken into close consideration, as there are different methods of introducing these stem cells to the body for enhanced efficacy.
A more aggressive method is often needed in those patients with conditions such as autism, Alzheimer’s disease, and kidney-related conditions. Other conditions can also be treated, such as pulmonary diseases, Parkinson’s disease. In cases of a stroke, the vascular arteries, along with the carotid artery, is targeted with the therapy for a more effective approach to assisting with the regeneration of damaged structures in the patient’s brain. This ultimately leads to a significant improvement in the delivery of stem cells to the patient’s body, which could enhance the overall efficacy expressed by the treatment.
When these procedures are provided to the patient through the GSCG, an appropriate ICU unit is made available to ensure the patient is provided with adequate care during the operation and recovery of the procedure.
The utilization of recent technological advancements at laboratories facilitated by GSCG can also assist in providing a more economical approach to cell therapy. The utilization of allogenic stem cell procedures can be addressed using techniques that will essentially offer a reduction in the costs involved.
Planar technologies may be utilized when the demand is less than one billion cells per annum, which can significantly reduce the costs of the process and, in turn, make these treatments available to patients at a lower price.
The utilization of autologous stem cell transplantation also offers an opportunity for patients to undergo stem cell therapy when a sibling does not provide an ideal match. Cells can be cultivated from the bone marrow and treated with specific drugs in order to yield targeted results. In the case of malignant cells in the body, bone marrow can be treated with monoclonal antibodies or cytotoxic drugs to target such cells when transplanted back into the patient.
Appropriate storage solutions are also taken into consideration to assist with the cultivation process, and to reduce the risk of enzymatic treatment leads to the differentiation of cells into other types. The culture condition becomes crucial for the expansion of stem cells. A PA6 conditioned medium, along with an enclosure of semi-permeable hollow fiber membranes, is one example of how the laboratory can keep certain stem cells from differentiating, while also assuring successful cultivation and expansion.
The GSCG’s Role In The New FDA Warnings
The fact that the FDA has announced the warnings against stem cell therapy products and had even taken action against a relatively popular company in the United States have now caused a limitation in access to these treatments. With a seizure of the services provided by companies that have been affected by the FDA’s actions and the knowledge of the misleading marketing information that was used in the campaigns initiated by these companies, patients might not be sure where to turn to right now.
The same problem is faced by many doctors in the field of regenerative treatments and medicine. Doctors in these fields need to ensure a facility they utilize to allow patients to undergo a treatment like a cell therapy can offer a safe procedure.
This is where the GSCG comes into the bigger picture. With the establishment of a permanent presence in Mexico, doctors are now given access to a facility that has an established history for providing quality stem cell therapy services to patients with qualifying diseases. The company is not only trusted but have been performing stem cell therapy procedures on patients that had led to successful results.
These treatments may help to assist in repairing neurological problems caused by disorders like Parkinson’s disease, stroke, or an injury to the spinal cord. They may also offer new hope to people with diabetes, heart disease, and even those who had previously suffered damage to their cardiovascular system due to a heart attack.
Even though recent publications from the FDA has caused concerns to be raised regarding stem cell therapy, many patients are still interested in undergoing these treatment procedures. A significant number of studies have provided evidence on the efficacy of treating tissue damage caused by various conditions through stem cell therapy. Patients interested in undergoing stem cell treatment are now advised to turn their interest to Stem Cells Centers in Cancun and related regions, where highly specialized and experienced doctors are able to provide a professional service.
- Published in Blog