Dec 29, 2014
Actually it is closer to stem cell misrepresentations and is being propagated by the uninformed clinician, clever marketing schemes, and out and out charlatans. Last week, the FDA made a very strong statement warning against the use of Adipose Derived Stem Cells in the treatment of arthritis. The Government Health Care oversight process stated that there would be large fines and perhaps imprisonment for those health care providers who do not comply with the law. The regulations clearly state that your stem cells may be used if not manipulated or expanded. In order to liberate stem cells from adipose tissue, the adipose tissue has to be treated with an enzyme collagenase, a clear violation of the law. Yet, there are the web sites too numerous to list marketing adipose derived stem cells for arthritis. I am aware of several clinics that circumvent the law by performing liposuction and injecting the fat into the joint without liberating the stem cells with collagenase. My response, beware and take care.
Then come those providers who use local anesthetics to expand the Bone Marrow Aspirate Concentrate when Regenexx has documented the death of stem cells if mixed with local anesthetics. Don’t stop reading, I have yet another alert. The latest addition to the field of Regenerative Medicine comes from Amniotic Fluid that is marketed as an allograft. The pregnant woman at term donates her amniotic fluid that is then processed and made available for wound healing or as an injectate for the arthritic joint in either a concentrated or powder form. While the early outcomes are promising for pain relief, no one has more than four months of outcomes monitoring for amniotic fluid preparations in arthritis. The processing laboratories claim an abundance of stem cells in the concentrate as well as large quantities of Cytokines and Growth Factors; but this is yet to be corroborated by independent researchers. The good news here is the latter research is taking place and more being planned; there should be preliminary data by mid 2015.
Assume if you will that you have an arthritic joint, and are not yet ready for a joint replacement or the extent of your arthritis still lends itself to non-operative management. How can you be sure that you are protected from the abuses I describe above? Regenexx initiated outcomes surveillance over five years ago and as an orthopedic surgeon, I joined and expanded those data points Regenexx studies two and a half years ago. No other Cellular Orthopedic or Regenerative Medicine initiative has the comprehensive Outcomes Data or basic research to support a clinical intervention recommendation, as do the members of the Regenexx Network. Beware here as well of non Regenexx Network web sites that post Regenexx Outcomes as if the patient is too uninformed to recognize the deception. If you want the truth, make an appointment: 847 390 7666
Tags: Amniotic, arthritis, athletes, Bone Marrow Concentrate, Clinical Studies, Interventional Orthopedics, joint replacement, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Regenerative, Regenexx, stem cells, treatment
Mar 15, 2012
In the beginning, there was an umbilical cord. The blood in that cord was and is an invaluable source of stem cells that is unique to your body and family. These cells may be used to treat nearly 80 serious medical conditions at last count including leukemia, other cancers, and blood disorders. Cord blood stem cells are showing significant potential to treat conditions that have no cure today as juvenile diabetes and brain injury. Saving your baby’s or your grandchild’s cord blood secures the best treatment option for a healthy future.
According to the U.S. Department of Health and Human Services, “This revolutionary technology (regenerative medicine) has the potential to develop therapies for previously untreatable conditions. Examples of diseases regenerative medicine can cure include diabetes, heart disease, renal failure, osteoporosis, and spinal cord injuries. I am now ready to announce my personal entry into the new world of regenerative medicine in conjunction with the Regenerative pain Center by having joined the Regenexx network of physicians. I will start screening patients for bone marrow concentrate pilot study as of March 25th. The actual clinical process will be introduced at the beginning of May at the Regenerative Pain Center. There is as yet no assurance that bone marrow concentrate rich with autologous mesenchymal adult stem cells administered in to an arthritic joint will reverse arthritis or even stop progression but with the anecdotal observations around the country, I believe that as an orthopedic surgeon, I might or could be able to delay or avoid a joint replacement. Our pilot study will be the first step. In order to qualify, a patient will need to meet certain criteria determined by history, physical examination, X-ray and MRI. At times, a diagnostic out patient arthroscopic examination or prior treatment may be part of the program. For those who don’t qualify for the study, the patient may still seek treatment with a self-pay alternative.
Transplant medicine uses stem cells to help treat serious diseases, such as cancers and blood disorders. Regenerative medicine is a new and rapidly advancing area of medicine focusing on developing treatments using stem cells to repair damaged tissues and organs. The estimates to date that someone in your family will use stem cells in a lifetime include:
Transplant Medicine: 1 in 217
Regenerative Medicine: 1 in 3
I am thrilled to announce my entry in to the emerging stem cell application regenerative process. To learn more or see if you qualify, call the number listed below.
Mitchell B. Sheinkop, M.D.
312-475-1893
1565 N. LaSalle St., Chicago, Illinois, 60610
Tags: arthritis, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Cord blood, medicine, Osteoarthritis, Regenerative Pain Center, stem cells, treatment
Feb 14, 2012
Musculoskeletal Care of the Mature Patient
Forbes , 02/10/2012 Gergana Koleva
Regenerative Sciences, a medical company that pioneered a procedure to treat orthopedic injuries using patients’ own stem cells, is fighting the Food and Drug Administration tooth and nail over a claim that human cells should be federally regulated as drugs, in a landmark case that has far-reaching implications for the future of regenerative medicine.
At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.
Despite the controversy, a number of clinics from coast to coast have licensed their physicians as recently as last month to provide the cell therapy, called Regenexx. This should have meant that some settlement had taken place (like in the case of Physiomesh lawsuit settlements), as well as has led to renewed interest by consumers and would-be patients, and prompted the company to publish a sharply worded blog post on its website condemning the FDA’s reasoning.
The lawsuit is “concerning for every American who considers their body not to be an FDA regulated drug factory,” the blog says.
While the treatment that is the focus of the lawsuit is not used for life-threatening injuries, the company claims this case goes beyond a particular procedure to shed light on a misguided push by the FDA to establish authority over aspects of medicine never allowed it by Congress.
Regenexx works by taking a blood sample and a bone marrow sample from a patient and separating out the stem cells via centrifuge, then re-injecting those cells directly into the injured area, where they assimilate into the bone or cartilage and begin to regenerate it. Physicians for the company have shown in clinical studies cataloged at the U.S. National Library of Medicine that the therapy produces fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.
You may read the entire article on the Forbes web site. On March 2, I will be visiting Regenexx to explore my joining their network of physicians using stem cells.
Tags: Clinical Studies, drug, FDA, medicine, Regenerative, Regenexx, stem cells
