Last Friday night, I was involved in a conference call with Personalized Stem Cells Inc., to review the outcomes of the first FDA-approved, Adipose Based, Stem Cell Trial and to assist in planning the second trial for knee arthritis. We hope to initiate the second trial, with FDA approval, by mid-June. Between now and then, the inclusion criteria for those who would become patients in this second trial will be established, in part, based on the analysis of the first trial. I am happy to report that there were no serious adverse events in the patients participating in the first trial, with the Adipose-Derived Stem Cells and Stromal Vascular Fractions having proved safe; and for the majority, effective. Such inclusion criteria as patient age and degree of arthritis in the symptomatic joint and the less involved knee will be established for the next FDA submission.
Arthritic Knee | Clinical Vignette
Now, for a change in subject matter and back to clinical orthopedics, a 64-year-old patient presented this morning with a specific request to treat his arthritic knee so he could get back to running since he has recently retired. An assessment was completed, and it was determined that the problem is grade two to three osteoarthritis of the left knee. A diagnostic ultrasound was compatible with an accumulation of intraarticular fluid termed an effusion. The latter is a result of inflammation, as the symptom generator and altered physical finding in an arthritic joint are the result of inflammation. I indicated to the patient that before making a therapeutic recommendation, an X-Ray and an MRI of the left knee would be necessary. The short-term recommendation is a Hyaluronic acid injection although the latter has neither anti-inflammatory nor regenerative potential. Both Cortisone injections and hyaluronic acid injections are short-term treatments if effective.
Based on the results of the X-ray and MRI, the patient may be a candidate for a Bone Marrow Concentrate intervention as a means of stopping the progression of arthritis, minimizing, or perhaps eliminating symptoms, and restoring functional capacity. The other alternative, should the patient not be deemed a suitable candidate for the use of his bone marrow, would be the use of Growth Factors, proteins found in his circulating blood. These anti-inflammatory Cytokines, manufactured by your platelets, immune system, and liver are proving as important as stem cells in minimizing the symptoms and functional impairment imposed by an arthritic joint.
Cell-Based Therapies | Using a Needle and NOT a Knife
The discipline of regenerative medicine is dynamic and rapidly evolving. This makes it that much more important for a patient seeking a needle rather than a knife, to minimize or eliminate the symptoms and limitations imposed by osteoarthritis to depend on experienced experts for care and treatment. Let there be no hesitation in seeking a second opinion before deciding on the best clinical path for you.
To learn more, visit my website at www.sheinkopmd.com where you will find a webinar on cellular orthopedics. For a consultation, call (312) 475-1893. To follow the progress in the introduction of the next phase Clinical Trial, watch this website or check www.personalizedstemcells.com.