Caution When Considering Umbilical or Birth Tissue Products
Caution should be used when considering birth tissue products. Some stem cell clinics state they have some baby’s stem cells, and because they are younger, they are better. In saying this, many false claims are made.
In the United States, in order to use someone’s stem cells, it must be the same day, and the same person. Otherwise, it is considered a DRUG.
Secondly, stem cell therapy must go through a rigid drug approval process with clinical trials, research, and ultimately the drug approval process.
What is being done now is non-Stem Cell products, which are not approved drugs, are being sold or marketed as drugs. These products lack living viable cells, known as devoid of cells. They can be marketed as tissue graft products, where wound care therapy has shown tissue matrix products containing growth factors had good healing properties.
Much of this original research was done on sterilized pig bladder, and small intestine submuscal (SIS) tissues, all lacking stem cells. What was found was in addition to the graft, recruitment of nearby stem cells already on adjacent skin took part in the overall healing process. A necessary role only the stem cell could do for complete healing.
These birth tissue products were promoted off label for nearly everything, because they didn’t need drug approval. False advertising and misrepresentation from the companies, and doctors promoting these tissue graft products. Quite simply there are no stem cells in our joints, or lack the abundance for self repair. This is why we develop arthritis as we age, or after trauma. In the animal kingdom, if you become lame, you are eaten.
Understanding the science is important. Sales pitches by individuals with little training or are motivated by marketing sales, is not scientific, it is unethical.
Several companies selling tissue grafts and at times misleading by stating stating stem cells were actually in their products, when in fact they were not, have gotten recalls, government warnings about false labeling, and injured patients. Invitrex sold a CMV virus infected donor tissue.
Liveyon sold contaminated vials with multiple harmful bacteria. These vials were injected into joints, spines and many other off label places resulting in serious infections. A spinal injection with bacterial contamination, can lead to a deadly infection. Liveyon then changed their product name to Liveyon Pure.
Really, your old product was infected with bacterial contamination, so the new marketing name is Liveyon Pure? Shouldn’t they other have been called Liveyon Unpure? Especially after multiple catastrophic contamination issues with patients knees, joints, spine after injecting epidural spaces. This is how people die from meningitis.
Birth Tissues: Umbilical, Cord Blood, Amniotic, Wharton’s Jelly, Placental
There is great promise in these stem cells being done with the International Perinatal Stem Cell Society, not quick start up local or unknown tissue banks from afterbirth tissue. Trusted Universities doing the real research is the gold standard, not a get rich quick marketing ploy.
Questions to Ask:
- Who is the donor?
- What is processing lab?
- Are they (GMP) Good Manufacturing Processing? This is essential.
The compounding pharmaceutical company in Boston with fungus in the injectable corticosteroids, was a good example of why certified drug manufacturing companies are needed shortcuts lead to greater profits, but expose patients to severe risk.
The compounding pharmacy in Boston that was shutdown after the fungal contamination was found, was too late. Doctors were using it IV and into the spine. Serious injections and deaths occurred. This shortcut in good manufacturing should never have happened.
What is a Drug Versus a Tissue Graft Product?
A drug meets FDA approved research processes to determine safety and whether it works.
A tissue graft is easily obtained through a application as a 401k process.
Skin grafts are not the same as Stem Cell science.
Having interacted with non-Stem Cell Tissue graft birth tissue companies, sales representatives, doctors and chiropractors, Physicians Assistants who are pitching these products, all lack the understanding of the science or don’t care.
Most of my interactions have been spine chilling scary, in that they don’t know what they are taking about babbling incorrect scientific statements. That is why they are doing this and not research in a University.
Why Do Inexperienced Doctors, Para-Professionals, and Chiropractors Use Stem Cell Vials?
Sad, but true. Birth Tissue companies are in the business of selling. They are everywhere. Competition is high. Because of this, ethics sometimes goes out the window.
They market the vials and the commissioned sales people promote it improperly as a “stem cell” product when its not. Then, the chiropractor or health care provider unknowingly or sometimes knowingly misinform the patients. It happens all the time.
Now the FDA, has sent warning letters to offenders, and has started prosecuting the first in a series of offenders.
One such offender, who trained chiropractors online, was told by the judge to never practice in the field of Regenerative Medicine and Stem Cells again.
Just like with Medicare fraud, there are government task forces going after people, companies, and anyone proclaiming false information in the stem cell arena.
False information, misinformation, and misrepresentation is not allowed for good reason. Patients can be harmed.
There is a big difference between a FDA approved DRUG therapy, and a Tissue Graft 361 form application. Tissue grafts for wounds fill out a quick 361 form for medical device approval.
An FDA drug therapy approved stem cell product requires rigorous clinical trials. At present there are only a few clinically approved FDA stem call drugs.
One is a pure stem cell drug for leukemia, derived from cord blood.
All the vials of amniotic, placenta, Wharton’s jelly, and such being promoted at seminars all around you, are tissue grafts with no viable stem cells.
The hook for patients is that younger stem cells are better, but if there are no stem cells per the FDA required rules, someone is selling you snake oil for profit.
Now, having lectured to University professors, Stem Cell Scientists and Tissue Engineering experts, Dennis M. Lox M.D. understands there are parts of the tissue graft with growth factors and other non-cellular factors that do help in healing.
In 2009 Dr. Steve Badylak, a Professor Dr. Lox has lectured with, was seen on the news program 60 minutes for his work with re-growing a wounded soldiers limb with a decellularized pig derived bladder product.
However, to re-grow fingers and limbs, the wound must be open to allow nearby skin stem cells to be recruited to grow a new body part.
This is the science the salesperson doesn’t tell you. It’s not good for their business model.
So when you’re ready to take the next step towards a stem cell procedure, be sure to ask your doctor where they get their stem cells from. If they don’t get the stem cells from your own body, run for the hills.
About Dennis M. Lox, M.D.
Whether you are a professional athlete, weekend warrior, or have arthritis from aging, Dr. Lox can help.
Dennis M. Lox, M.D. is an internationally renown Sports and Regenerative Medicine specialist. Dr. Lox incorporates Regenerative Medicine techniques such as cell science applications, Platelet Rich Plasma (PRP), and Tissue Engineering aspects, to help patients from around the world with a vast array of problems. Dr. Lox is board certified in Physical Medicine and Rehabilitation. Dr. Lox lectures extensively and has edited two PM&R textbooks, the prestigious A State of the Art Review (Star) on Low Back Pain, and Soft Tissue Injuries: Diagnosis and Treatment.
Dennis M. Lox, M.D. maintains an active practice in the Tampa Bay, Florida area, and in Beverly Hills, California.