Because of the COVID-19 crisis, many surgeries have been cancelled or delayed for patients who qualified for, or had scheduled a total joint replacement or other orthopedic surgical procedure. Post COVID-19, operating rooms will be occupied by other urgent procedures (cardiac, cancer) and many elective procedures will be backlogged. In other words, you may have to wait many months for an elective orthopedic surgical procedure. I am able to provide patients with another option; a procedure that is supported by strong scientific evidence, minimal risks and complications, can be easily performed in the office, and that is FDA cleared for use in orthopedics. These interventions might, or could be, covered by Medicare or private insurance options. This is a great way to keep you in the care continuum with a solution that may provide benefit to you and help you postpone, perhaps even avoid a joint replacement.
An Option for Joint Anthroplasty
April showers bring May flowers
On another note concerning the Personalized Stem Cell Trial, we have high hopes our office will restart the study enrollments in mid-May. My co-investigators will update each of you already enrolled on the timetable and next steps. They realize that those of you already screened will need eligibility reconfirmation and a clinical pathway re-run. We will want to make sure you still qualify and it is safe to proceed including COVID-19 testing.
PSC also has other news on the COVID-19 front. They filed a second Investigational New Drug (IND) application last Wednesday; and, hope to hear from the FDA this week enabling the treatment of COVID-19 patients with allogeneic adipose stem cells while doing their part in the war. The data from the outcomes will also help with upcoming Personalized Stem Cell studies.
Last of all, PSC is considering filing next week to use Stromal Vascular Fraction, that is stem cells from fat (SVF), to treat individual COVID-19 patients after they leave the hospital focusing on the lung damage and fibrosis. Scientists are learning that patients requiring respirators during hospitalization may be at risk for permanent lung disease. An Adipose derived stem cell intervention for active or prevention of lung disease would work nearly identical to our knee study but patients would receive their SVF via intravenous infusion instead of joint injection.
You may visit my website www.sheinkopmd.com or call (847) 390-7666 to schedule an appointment
More later. The latest press release is here: https://www.einpresswire.com/article/514448157/covid-19-emergency-stem-cell-treatment-collaboration-in-san-diego?r=pavRhtj3xPv5Gge7AI
Tags: cell therapy, FDA approved stem cell research, joint anthroplasty
DEFENSE HEALTH AGENCY 7700 ARLINGTON BOULEVARD, SUITE 5101 FALLS CHURCH, VIRGINIA 22042-5101 MEMORANDUM FOR DEPUTY CHIEF, READINESS AND HEALTH, BUREAU OF MEDICINE AND SURGERY DEPUTY CHIEF OF STAFF G-3/5/7, OFFICE OF THE SURGEON GENERAL DIRECTOR, MEDICAL OPERATIONS AND RESEARCH, OFFICE OF THE SURGEON GENERAL DIRECTOR, NATIONAL CAPITAL REGION MEDICAL
DIRECTORATE SUBJECT: Use of Regenerative Medicine Advanced Therapy (RMAT) Products Not Approved by the Food and Drug Administration (FDA).
Regenerative Medicine Advanced Therapy (RMAT) products not approved by the FDA have the potential to expose patients to unnecessary risk. One such product is injectable micronized dehydrated human amnion/chorion membrane (dHACM) used to treat conditions such as plantar fasciitis, tendonitis or osteoarthritis. Any of these products not approved by the FDA are considered investigational, at present. Therefore, effective immediately, all MHS facilities will stop using injectable RMAT products not approved by the FDA, including dHACM. Once the FDA has approved an RMAT product, further review will occur. The Veteran’s Administration has taken a similar action.
PAUL R. CORDTS, MD Deputy Assistant Director – Medical Affairs Defense Health Agency
At the same time I was made aware of the above Defense Department Memorandum, a patient called my attention to a brochure she had received in the mail on the same day recruiting “victims” to one of several offices in metropolitan Chicago treating patients with the very product that the Defense Health Agency classified as unapproved by the FDA and therefore prohibited for safe use. A day later. I received an e-mail from a health care provider out of state, a non-MD asking me about use of “stem cells and amniotic fluid in my office.”
Are these alleged members of the health care community charlatans, uninformed, or just plain dumb and dumber? “Beware, take care, of the Green-eyed dragon with 13 tails, he’ll feed, with greed”. There is only one FDA approved source of stem cells for arthritis available in the United States and I am pleased to have been designated a Clinical Investigator in the PSC Trial. You may read about it on my website at www.sheinkopmd.com or at www.personalizedstemcells.com . The other potential biologic alternatives that, to the best of my knowledge are approved at this time, involves using your bone marrow as a regenerative option for delivering Adult Mesenchymal Stem Cells, or Platelet Rich Plasma obtained from your circulating blood as resource for Growth Factors.
To learn more or to schedule a consultation, call (312) 475-1893
Tags: clinical trials, FDA approved stem cell research, regenerative medicine, stem cell research