Pulmonary hypertension is serious life threatening condition characterized by an increase in blood pressure in the pulmonary artery or vein. It is can result in shortness of breath, dizziness and fainting. In severe cases, patients have severely decreased exercise tolerance and heart failure.
Treatment options to date have included a large number of medication’s including calcium channel blockers, prostaglandins, endothelin receptor anatagonists and phosphodiesterase inhibitors. Median survival rate in patients untreated is 2-3 years from time of diagnosis. Unfortunately for those patients who have failed conventional therapy, there has been no treatment options until recently.
Dr. Grekos reported significant clinical success utilizing adult stem cell therapy in treating pulmonary hypertension. Dr. Grekos notes: This is the first time medical science has successfully reversed the disease process in pulmonary hypertension, a previously untreatable condition with a very grim prognosis,”
Unfortunately such therapy may not be available if the FDA continues to exert its jurisdiction. The FDA contends that a patient’s own stem cells are a biologic drug over which they have jurisdiction. A physician based organization has been formed which established both clinical and laboratory guidelines for the safe use of adult stem cell therapy: stemcelldocs.org
Today the American Stem Cell Therapy Association (ASCTA) announced publication of the world’s first clinical guidelines for stem cell therapy. The guidelines will allow for safe, adult stem cell therapy utilizing a patient’s own stem cells. The is a significant advancement beyond other guidelines.
ASCTA is a national physician group comprise of various medical and surgical specialities dedicated to bringing safe stem cell therapy to patients by establishing laboratory and clinical guidelines.
A national, patient-driven movement has been formed in response; SafeStemCellsNow.
The FDA announced yesterday that Cheerios will now be treated like a drug with the FDA monitoring the claim that the breakfast cereal can reduce one’s cholesterol. The FDA indicated that they found serious violations of the Federal food, Drug and Cosmetic Act. Remember, this is the same federal agency that contends that your own stem cells are a biologic drug over which they have jurisdiction.
A patient summarized it well:
Why stop there? It can be clinically proven that food is the only cure for death by starvation, therefore grocery stores will have to become drug stores, and instead of a shopping list we’ll need to carry weekly prescriptions for bread and milk. For that matter, we would die of thirst before hunger, so at what point does water come under the jurisdiction of the FDA? How about licensing fees for home gardens?
Stem cell therapies continue to have increasingly successful applications.
A patient movement, called Safe Stem Cells NOW has recently been formed as a response to the classification of a patients own stem cells as a drug. The patient group believes that this misclassification of adult stem cells will dramatically slow the availability of stem cell therapies.
The American Stem Cell Therapy Association (ASCTA) has created an on-line publication of its patient web-site, www.safestemcells.org, which reflects the activities and opinions of patients behind the Safe Stem Cells NOW movement.
Please take a movement a listen to what patients are saying: www.safestemcells.org/Patient_Voices.html
My Cells Are What?
One million patients in the United States suffer from angina: chest pain due to blockage of the arteries in the heart. Thirty-three percent of these patients are not afforded any benefit from traditional therapy such bypass surgery, oral medications or insertion of stents in the blocked vessels.
Adult, autologous stem cell therapy has recently been demonstrated to be of benefit to these patients. At Northwest University, 167 patients with severe angina underwent a prospective, randomized study in which autologous, adult stem cells were injected into the heart muscle. Six months after the procedure, those patients who had received autologous stem cell therapy had significantly improved exercise tolerance. These are the same patients who were not candidates for conventional therapy.
If you are a patient and disagree with their proposed restriction of your healthcare, please visit: www.safestemcells.org.
Two items had major headlines this week: adult stem cell therapy for cardiac patients and the snow in Vail. Two recent storms have brought record amounts of snow to Vail. Words alone can not accurately describe the back bowls!
Back Bowls in Vail
Physicians at Emory University have demonstrated that infusing bone-marrow-derived, autolgous stem cells in patients who have sustained a heart attack and underwent angioplasty, had an increase in blood flow to the heart. The study examined the significance of injecting three different amounts of stem cells: 5, 10 and 15 million cells. At three months, the patients who received higher doses of stem cells showed the greatest improvement in blood flow to the heart. This is very promising technology and has the potential of re-defining the management of patients with heart disease.
The evolution of In-Vitro Fertilization (IVF) illustrates the development of a minimal culture expansion process. In the late 1970′s, the first IVF was performed. In the 1990′s, in an effort to improve conception outcomes, fertility specialists elected to extend the cell culture time. Specifically they extended cell culture to the blastocyst stage which is a more mature developmental phase. In doing so, the fertility specialists transitioned In-Vitro Feritlization from a simple tissue transplant to a cell culture technique. These specialist maintain that their cell culture techniques are the practice of medicine and not the production of biologic drugs. No parents who have undergone IVF, think of their daughters or sons as biologic drugs, do they?
Adult, autologous stem cell therapy was found itself on a similar path. In an effort to optimize clinical outcomes, some practices expand a patients’ own stem cells thereby increasing the total number of cells available. Expansion takes 12-14 days and is conducted in a state of the art cell culture lab. No growth hormone or exogenous products are used to increase the cell count. If you are a patient who is concerned that this therapy may no longer be available please visit: www.safestemcells.org
Autologous, adult mesenchymal stem cells have proven to be an effective therapy for patients who have orthopedic injuries. Specifically, autologous, adult mesenchymal stem cell therapy has regenerated cartilage in knees, hips and thumbs, repaired tendon injuries, reduced the size of protrusions in the lumbar spine and healed long bone non-union fractures.
Regenexx isolates a patients own mesenchymal stem cells in a state of the art cell culture laboratory. Then, in an effort to provide maximal clinical results, it expands the stem cells by a factor of 1,000X. The process takes 12-14 days and typically yields a mesenchymal stem cell count of 5-10 million cells. The stem cells are expanded through the use of the patient’s own blood products. No growth hormone or exogenous stimulates are utilized. The patented process is unique in its ability to yield such a large number of autologous, mesenchymal stem cells.
In a previous blog, I discussed BMAC: Bone Marrow Aspirate Concentrate. The therapy involves taking a patients bone marrow, concentrating it via a centrifuge and re-injecting the concentrate into the area of damaged tissue. The entire process is conducted in a single setting. There is no isolation or culture expansion of the stem cells. BMAC differs significantly from the Regenexx procedure in the type and absolute number of stem cells injected. BMAC yields a high concentration of hemapoetic stem cells which will differentiate into blood products. The important repair stem cell, mesenchymal stem cells, are in very low concentrations.