Special Announcement - Now Screening for FDA Approved Stem Cell Study
Dr. Mitchell Sheinkop has completed training and is credentialed for an FDA-approved stem cell clinical trial for knee arthritis. Our clinic is now screening patients for this trial. Contact us at 312-475-1893 for details. Click here to learn more.

Bone Marrow Concentrate for Arthritis; the potential benefits and risks

Mar 8, 2012

      

Musculoskeletal Care of the Mature Patient

The potential benefit of regenerative medicine is avoidance of orthopedic surgery. That’s the goal and I am the orthopedic surgeon leading the charge. I have spent several years now investigating, meeting, traveling, learning and preparing for that reality with the start-up anticipated in mid-April. While there is anecdote about subjective improvement following autologous, mesenchymal, Bone Marrow Concentrate derived stem cells for management of arthritis, there are no peer reviewed published long-term clinical outcomes to the best of my knowledge. There have been testimonials by orthopedic surgeons that following the adjunctive use of stem cells in conjunction with arthroscopic micro fracture of an arthritis knee, when the patient subsequently underwent knee replacement, hyaline cartilage was observed growing rather than fibro cartilage. This is not good enough for me, as I want a procedure that will postpone the need for a joint replacement or possibly eliminate that need. Is it a matter of when to intervene with regenerative medicine? When there is major deformity of an arthritic joint, significant alteration in function and a “bone on bone” X-ray, it probably is too late. Will regenerative medical intervention delay the joint replacement by a three to five year control of pain by the anti-inflammatory nature of bone marrow concentrate or will the joint cartilage actually re-grow? These are unanswered questions and what I seek to learn as I embark on my clinical project

Recently, the orthopedic surgical spine community became aware of a fourfold risk of cancer in patients who underwent spinal fusion using Bone Morphogenic Protein to increase the likelihood of successful fusion. As a result, attention quickly was redirected to stem cells as an adjunct in spinal surgery to replace human BMP. As of this writing, I have found no evidence of carcinogenesis in conjunction with autologous, mesenchymal Bone Marrow Aspirate Concentrated stem cells used in the skeleton and certainly not when used in a joint. The same might not be said when embryonic stem cells have been injected into the blood of patients to treat probably what shouldn’t be addressed with stem cells in the first place. Desperate people are not infrequently victims of charlatans as has been repeatedly pointed out on 60 Minutes. Contrast the risks of stem cell misdeeds with the benefits of scientific application. Today, the AMA News headline covered the potential for stem cells to eliminate the need for long-term anti-rejection pharmaceuticals in organ transplant recipients.

How to avoid orthopedic surgery by an orthopedic surgeon? Not just a mission statement by an ethos. Call to see if you are a candidate.

Mitchell B. Sheinkop, M.D.

312-475-1893

1565 N. LaSalle Street, Chicago, Illinois 60610

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An experimental treatment offered for sale is not the same as a clinical trial.

Feb 6, 2012

Musculoskeletal Care of the Mature Athlete

As I move closer to actually starting up the Bone Marrow Concentrate Stem Cell Pilot Study, I will continue to educate the perspective patient seeking to enjoy relief from arthritis of the hip and knee without a joint replacement. The delay is based on our having to wait for Institutional Review Board approval of our clinical trial. The fact that a procedure is experimental does not automatically mean that it is part of a research study or clinical trial. A responsible clinical trial can be characterized by a number of key features. There is preclinical data supporting that the treatment being tested is likely to be safe and effective. Before starting, there is oversight by an independent group such as an Institutional Review Board or medical ethics committee that protect patients’ rights, and in many countries the trial is assessed and approved by a national regulatory agency, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA). The study itself is designed to answer specific questions about a new treatment or a new way of using current treatments, often with a control group to which the group of people receiving the new treatment is compared. While historically, the cost of the new treatment and trial monitoring is defrayed by the company developing the treatment or by local or national government funding; to date that has not occurred with stem cell trials in the United States. It takes an average of seven years and $750,000,000 to develop a new pharmaceutical therapy. With the rapidity in evolution of regenerative medicine, so far, no company has been identified that is willing to underwrite the expenses of a stem cell Trial. At the same time, beware of expensive treatments that have not passed successfully through clinical trials.

Responsibly conducted clinical trials are critical to the development of new treatments as they allow us to learn whether these treatments are safe and effective. I believe there is enough clinical experience to support a Pilot Study with Adult, Autogenous, Bone Marrow Derived Stem Cells. First no harm and a then reasonable chance of restoring function. To find out if you would qualify for the Pilot Study, contact Jennifer at 312-475-1893   ext.15

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