The dangerous drug and products team at MahanyLaw is investigating PlasmaGenix, yet another stem cell business that causes us grave concern. We are investigating a claim from a patient that received a stem cell injection of product made by PlasmaGenix. Instead of helping him recover from knee replacement surgery, he says he developed an infection and spent weeks in the hospital. Today he can’t walk without assistance.
PlasmaGenix is a subsidiary of Earth Dragon Resources, Inc. A 2015 SEC filing says the company originally was formed in 2007 to mine minerals in Nevada, Quebec and Africa. Shortly after its formation, the company changed its business focus on hunting for underwater treasure on ship wrecks. In 2014, the company announced it was switching gears yet again, this time to manage PlasmaGenix.
According to government filings, Plasmagenix is “primarily focused on the development of regenerative therapeutics derived from a patient’s own blood and facilitating access to treatment, particularly in high-risk populations. Its lead products have been used to treat chronic pain, sports-related injuries, non-healing wounds as well as debilitating neurological conditions associated with HIV, diabetes, muscular sclerosis, and Charcot-Marie-Tooth disease.”
The company claims it has treated 10,000 patients.
Unlike pharmaceutical companies that have been around for decades, PlasmaGenix / Earth Dragon reminds us of a child with a severe case of ADHD. Treasure hunting, mining in Ghana, treating rare diseases. The rapid progression from one business model to another does not inspire confidence.
In their 2016 regulatory filing, the company freely admitted it was heavily dependent on key personnel, that their key personnel controlled most of the company, and that its management team was inexperienced in running a public company. Perhaps most importantly, the company conceded that it had “limited operating history” within the stem cell industry.
None of these admissions make us feel comfortable or inspire confidence in their products.
That a patient came down with a rare infection at the injection site is especially concerning.
We have long warned about the false promises inherent in the stem cell industry. Many companies make miracle cures claims that they cannot deliver. Because the most effective stem cell products rely on live stem cells, the danger of infections is very high.
We see two things within the industry. There are some companies that deliver freeze dried stem cells. Although the infection risk is low, a dead stem cell is useless. You are paying thousands of dollars for something that won’t work.
The best stem cells are live. of course, without very tight quality controls, the risk of infections is high.
Compounding the problem is that the industry is relatively new. The labs making these products are often inexperienced and don’t follow FDA current Good Manufacturing Practices rules (cGMP). In recent months, the States of Texas and Florida found stem cell products infected with E. coli, Enterobacter cloacae, Citrobacter freundi and other disease causing bacteria.
Some of these companies advertise miracle claims and prey on people desperate for a cure for cancer or HIV or some other serious disease. People will spend thousands on a company with no track record. And all too often, the product you receive makes you worse.
None of the FDA recalls have been tied to PlasmaGenix. That doesn’t mean that their products are safe, however.
Some of the tested products that tested positive for contamination were FDA registered, that does not mean they were FDA approved or used in an approved manner.
The FDA has warned repeatedly about the risks associated with stem cell products. “Regardless of when contamination occurred, this investigation highlights the serious potential risks to patients of stem cell therapies administered for unapproved or unproven uses… [Some] clinics operate in outpatient settings, which often have less robust oversight of infection control measures, including injection safety and medication preparation potentially amplifying risk to patients.”
And that FDA quote brings up another concern. Practitioners and clinics dispensing stem cell products that have no business doing so. Unfortunately, the industry is still like the wild west.
We have seen nurses and chiropractors administering or dispensing stem cell products. Can a nurse give an injection? Sure! But they should not be the ones recommending such new and still untested products.
We have no problem with the concept of stem cell therapy. Until the FDA steps in with real standards and begins to clean up the industry, however, we are worried that many patients are either being defrauded or exposed to dangerous product manufactured by start up labs with little experience and poor quality control. We also believe that too many practitioners are prescribing stem cell therapy for uses where it may be more of a danger than a cure
If you have used products manufactured by PlasmaGenix ad developed and infection or serious adverse reaction, please call us. All inquiries are confidential and available at no cost and without obligation.
The makers and distributors of these products can be held liable for the harm they cause. Damages are available for pain and suffering, lost wages and medical expenses.
According to the PlasmaGenix website, the company manufactures a product called Belleza. (The company’s website says almost nothing about their product line, something that also concerns us.) The SEC filing lists three primary products, PlasmaPro, PlasmaGen and PlasmaNeu.
For more information, visit our Stem Cell Product Injury Information page. We also have specific pages about products made by StemGenex, Liveyon and Regen. All can be accessed from our cornerstone stem cell page at the link above. Ready to see if you have a case? Contact us online, by email at *protected email* or by phone at 202-800-9791.
MahanyLaw – PlasmaGenix / Stem Cell Injury Lawyers
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