Do Your Research
In an age where we have a veritable sea of information within arms reach, at almost all times, it’s easy to fall prey to false information. In recent years, the FDA has cracked-down on clinics craving to profit off of innocence. Unsanctioned clinics, promising the ‘holy-grail’ of curatives, are claiming that their facilities are equipped to cure debilitating disorders like Alzheimer’s, paralysis, and other neurodegenerative diseases with nothing more than stem cell treatment.
One might conspire, ‘if that’s the case, it’s only because they’re trying to save money by avoiding unnecessary regulations on clinical trials’. Well, one could assume that but there’s a problem: these providers aren’t necessarily servicing others with newfound knowledge gained from research. As a matter of fact, they are offering stem cell products that are both unapproved and unproven through research and trial. As a forewarning, it is a must that if one is to pursue stem cell research, it is with a reputable clinic that freely discloses the nature and result of their evidential analysis.
How Could It Be Dangerous?
The fact is, stem cell therapy offers hope for those who previously felt hopeless. In the last two decades, there have been significant breakthroughs in what providers are capable of, in terms of treatment. For example, superior regenerative medicine has shown a new and improved method of reprogramming one’s cells into induced pluripotent stem cells (iPSC). IPSCs are derived from the skin or blood cells and reintroduced into their original embryonic pluripotent state where specialization is possible.
The process of assigning these cells with an unlimited potential originally meant using various reprogramming proteins, OCT4, SOX2, KLF4, and cMYC, and applying them, individually, in order to change their form. However, due to the frequent infusion of new protein every cycle, there is a greater margin of error, resulting in some cells with incomplete programming. As one can imagine, this can affect the cell’s efficiency and overall capability to specialize with full functionality.
Consequently, researchers developed a method utilizing single cycle measle vectors for far more efficient use in clinical trials. It has been commented on as “safe, stable, faster, and usable”. The researchers plan on using those stem cells to treat patients without the worry of transplant rejection, mutation, or cancerous growth.
Given the endless possibilities of what stem cells can accomplish ( repair, restoration, replacement, and regeneration) it’s understandable that enervated patients would wish to hope in some manner of relief. But the U.S. Food and Drug Administration is concerned that some patients will seek remedies in the wrong place. They could be deliberately inviting further self-harm by enlisting in treatments that are illegal or questionable. By expanding its enforcement and discrediting dishonest stem cell clinics, the FDA is able to maintain the safety of patients while encouraging innovation in the medical industry. They remind patients to do their part and make sure that the stem cell treatment is FDA-approved or being studied by Investigational New Drug Application (IND). FDA-approved means that the products went through a thorough FDA review process – assuring sufficient product quality and requiring data from animal studies. These determine the safety, potency, and effectiveness of the product in clinical trials.
What Happens If The Clinic Isn’t Accredited?
In this case, if the clinicians argue that such examination isn’t crucial and go along without proper accreditation, then it simply means that the FDA has not reviewed the experimental therapy to make sure it’s reasonably safe for others. Extreme caution is advised. Be wary of any stem cell-based product that isn’t consisting of blood-forming stem cells, or hematopoietic progenitor cells (HPC), collected from cord blood. It is only these products that are approved for usage in patients with disorders that affect the production of blood. Bone marrow is also used for these treatments but is not usually regulated. Listed below are some FDA-approved stem cell products:
- Allocord (HPC Cord Blood)
From SSM Cardinal Glennon Children’s Medical Center
- Hemacord (HPC Cord Blood)
From the New York Blood Center
- Clevecord (HPC Cord Blood)
From the Cleveland Cord Blood Center
From Dendreon Corp.
From Kite Pharma, Incorporated
From Organogenesis Incorporated
Safety Concerns For Unproven Stem Cell Treatments
If you still feel a conspiracy brewing, then this incident will convince you as to why they should shut down unsanctioned clinics. In 2016, the FDA hosted a public workshop to promote the awareness of unofficial stem cell clinics and their potential dangers. Of course, people understand that all medical treatments have benefits and risks but the problem is staying aware, specifically about unproven stem cell therapies because they are particularly unsafe. For instance, one patient went blind due to an operation of stem cell injection into the eye. Another patient received a spinal cord injection and grew a tumor, due to the cells becoming cancerous. The FDA notes: “even if the stem cells are your own cells, there are still safety risks…”. Listed below are a few safety concerns and supportive reasons regarding how unproven treatment can be detrimental.
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Possible Safety Concerns:
- Administration site reactions – pain, swelling, bruising, severe tenderness.
- For treatments to provide any kind of beneficial effect to patients, the FDA does not require larger studies than what’s absolutely essential in order to prove that the benefits outweigh the risks.
2. The migration of cells from their original injection site and transformation into an unintended cell type.
- For example, autologous stem cells were taken from fat cells and injected into the eyes of patients with macular degeneration. The result: the operation blinded two out of three patients and permanently worsened the vision for the last person.
3. Cells growing uncontrollably, leading to the formation of tumors or cancerous growths. Even if the cells are extracted from the same individual (autologous), it doesn’t necessitate that cancerous growth cannot occur.
- In one instance, there was a case where autologous hematopoietic stem cells were injected into the kidneys of a patient with renal failure – tumors developed that eventually led to nephrectomy – culminating in the absolute removal of one or both kidneys. In this situation, stem cells may have been the answer, but without proper research, it caused far more harm than good.
4. The failure of cells working as expected – in this case, the functionality or efficiency of the stem cells are not 100%.
- The reason being that cells comprise “tens of thousands of different proteins, lipids, carbohydrates, and other molecules…” – therefore, there is a complexity that makes introducing and predicting stem cell behavior as potentially problematic. As a result, there is no scientific reason to believe that without research and testing, stem cell therapy would perform as it was designed.
In 2018, a report was published by the U.S. Centers for Disease Control and Prevention detailing 12 stem cell therapy patients who developed infections so severe that they required hospitalization. Seven of the cases occurred in Texas, four in Florida, and one in Arizona.
Between February and September of 2018, it was discovered that these patients had a series of similar complaints – chronic pain, rheumatoid arthritis, and rotator cuff tears. However, due to inappropriate and possibly unsanitary treatment, E.Coli was found in the patient’s’ joints or bloodstreams. As indicated in the report, one patient was hospitalized for as long as 58 days. The CDC investigators implicated one Texas Clinic in all seven cases because the E.Coli bacterium was found nestled in all six vials containing stem cell products. At other implicated clinics, there was additional evidence of E.Coli’s presence. It seems the presence of the bacterium is attributed to the point of manufacture and not the actual clinic themselves. Still, prevention is better than avoidance; a hospitalization stay for 58 days shouldn’t be necessary to convince others to do their research on the clinics available.
What’s Really Approved
Currently, the only stem cell treatments approved by the FDA are products that treat certain cancers and disorders of the blood and immune system. ‘Peddlars’ who promote their product as being used for arthritis, injury-related pain, joint paint, or any other health issue, are not using anything approved by the FDA. Unless they are part of a study under an IND – discussed in the beginning – then the FDA has the authority to regulate and remove any product that may be falsely advertised. The safety of stem cell therapies for indications other than hematopoietic reconstitution cannot be taken for granted. It is painful to live with a disorder but hastiness causes so much more pain. In the New England Journal of Medicine, they discuss the excitement over stem-cell therapy and the risks that have occurred due to its emergence. In a recent case, a patient was treated with multiple injections of allogeneic stem cells in order to cure neurological deficits of a cerebral stroke. The development afterward consisted of glial proliferative lesions, which led to paraplegia and required radiotherapy.
Considering Treatment In The U.S:
If you’re considering treatment in the United States, here’s what you should do:
1. Ask if the FDA has reviewed the treatment: this could mean talking to your healthcare provider and asking for recommendations. If talking to the clinical investigator, ask for an FDA-issued IND Application number and if you could confirm the communication between the clinic and the FDA. Always ask these types of questions before signing up for any kind of treatment – even if the stem cells are yours.
2. Ask questions about anything you don’t understand: to participate in a clinical trial requires the individual to sign a consent form detailing the experimental procedure. If you don’t understand the experimental procedure, ask questions! This consent form is meant to assure the protection and rights of any participant.
3. Do your research: understand the risk and benefits of the treatment and discuss it with your healthcare provider if you feel your consent isn’t fully informed. Any FDA-approved trial is seeking your utmost safety and satisfaction so don’t be afraid to talk to the clinical investigator.
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