First of all, let me expand on the concept of Regenerative Medicine at times also understood as Cellular Orthopedics or Stem Cell therapy. Cells with stem cell properties are present in bone marrow, the peripheral circulatory system, adipose tissue, synovial tissue, muscle tissue, and tendon. At this time, the FDA allows point-of-care bone marrow aspirate intervention for arthritis. From a clinical standpoint, the stem cell concentrate of bone marrow aspirate is technique-dependent and I have found it to be an ever increasingly important factor of therapeutic benefit. When it comes to Adipose-Derived Stem cells, use of these products places risk upon the clinician and the patient because they do not meet the criteria of homologous use and are not autologous. Enter the latest interest in amniotic fluid concentrate with all the marketing hype. As of this time, to the best of my knowledge, there is no clinical outcomes science to justify such use. I should know as I am the Principal Investigator in the largest Clinical Trial involving amniotic fluid for arthritis ever undertaken.
Next, the reader should understand that Osteoarthritis is graded, not all OA is the same. To qualify for a Regenerative Medicine procedure, the degree of arthritis must not exceed grade three based on Imaging and Physical Examination. The standard grading system is termed the Kellgren-Lawrence Scale in which the X-ray image is scored. The physical examination is also taken into account to confirm that the extent of degenerative deformity has not exceeded inclusion criteria.
Now let me explain how Stem Cell intervention is accomplished in my setting, who may benefit, and when Regenerative Medicine is not a reasonable option. Actually if you watch my Webinar,
you will better understand.
What are a patient’s options when a first intervention isn’t long lasting? Assume if you will that you have not realized the outcome that would be satisfying to you and rewarding to your interventional orthopedic specialist; there are two options:
Repeat Stem Cell Procedure
I have had at least ten patients in my practice who ultimately reached their goals after a repeat Bone marrow stem cell intervention
While it is a procedure that we seek to postpone, perhaps even avoid with a Regenerative Medicine intervention, stem cell procedures do not burn bridges
After watching my webinar, to learn more or schedule an appointment call 312 475 1893
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, treatment
There are now available six month follow up Outcomes Data regarding 20 patients who underwent a fat graft harvest, micro-fracture of the fat graft and intervention in an arthritic knee, the latter so severe that the original recommendation to the patient had been a Total Knee Replacement. 85% of this group are very satisfied at this time with the post intervention pain relief and functional improvement. One patient did elect to undergo a Total Knee Replacement eight weeks after the initial intervention. While six-month Data is very preliminary and doesn’t lend itself to a scientific journal publication, I am told the results will become the subject matter of a White Paper, an authoritative report, while the outcomes of the 20 patients will continue to be monitored.
As I have previously reported, I personally am taking a Principal Investigator role in a Clinical Trial centered on the most contemporary ortho-biologic methodology for processing Amniotic Fluid Concentrate. What piqued my interest is the continued marketing placements in our media: ”Stem Cell therapy is an exciting new therapy option that treats arthritis”. “Free Educational Seminar”. “Stem cell regeneration utilizes amniotic stem cells”. I am reminded of the prank I used as a child on my playmates “Pete and Repeat were sitting in a boat, Pete fell out, who was left?” As I have written on my Blog multiple times, there are no viable stem cells in amniotic fluid once processed, irradiated, frozen and fast thawed. That is not to say that AFC may not act as an anti-inflammatory eventually replacing visco-supplementation in attempting to improve the well-being of patients affected by arthritis; but it has no regenerative potential. My interest in leading a Multi-Center Clinical Trial -no out of pocket expense for those who meet the inclusion criteria-is to learn appropriate dosage and duration of effect if any. Subchondroplasty continues to be a subject of increasing interest in the orthobiologic world. I will be serving as a Principal Investigator in a stem cell based subchondroplasty clinical trial as soon as there is IRB approval toward the end of August. I hope to determine if a combined intraarticular and extra-articular Bone Marrow Concentrate approach will result in superior outcomes when contrasted to the standard intraarticular approach.
Be advised and reminded the Regenerative Medicine discipline is evolving and the over seer is the FDA. Make sure that should you decide to pay unreasonable amounts for unproven therapies, those marketing such are doing so under an IRB regulatory methodology. To learn more, schedule an appointment:
312 475 1893
Tags: Amniotic, arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, stem cells, Subchondroplasty, treatment
As the regular readers of this Blog are aware, one way to catch my attention is to send me another announcement found in a local newspaper regarding “free” Amniotic Fluid Concentrate seminars in which the reader (victim) then learns at the seminar that he or she can receive stem cells to cure whatever ails that person for a fee ranging between $7,000 and $9,000.
Based on what is scientifically certain about Amniotic Fluid Concentrate, in spite of what you are told at these seminars by the marketing spokesperson, there are no viable stem cells once the amniotic fluid is processed, concentrated, gamma irradiated, and fast thawed for the injection. Nevertheless, the Camp Followers are saturating the media with claims of benefit for almost every malady known to mankind by paying this exorbitant sum for a single injection. That is not to say there is not anti-inflammatory benefit and growth factor content in amniotic fluid concentrate so there is some pain relieving potential. What is not known is the optimal dose schedule, dosage concentration, and the duration of benefit.
In order to scientifically determine how to properly use amniotic fluid concentrate in a clinical practice and statistically measure value, I have accepted the invitation from a major Ortho-biologic producer of amniotic fluid concentrate to participate in a multicenter Clinical Trial under FDA regulatory scrutiny. Our study group will determine the benefit of amniotic fluid concentrate in the arthritic knee, the proper dosage schedule, the appropriate concentration and the duration of effect.
For those who elect to partake in this Clinical Trial and who meet inclusion criteria, there is no charge for the pharmacologic agent (Amniotic Fluid Concentrate). On the contrary, the participant will be reimbursed for travel expenses. By helping us understand the benefit of Amniotic Fluid Concentrate (if any) when used for an arthritic knee and determining appropriate dosage scheduling, the Ortho-biologic industry and we clinicians will finally learn if it works; and if so, for how long and at what dosage. So you decide, either call the number appearing in the media ads and be ready to pay up to $9,000 for a stem cell intervention without living stem cells or call 312 475 1893 to learn if you meet the inclusion criteria for the Multicenter Trial.
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment
In the late summer of 2015, I was featured on a Fox cable news segment featuring a patient on whom I had performed a Bone Marrow Aspirate Concentrate –Stem Cell intervention coupled with a subchondroplasty procedure. The patient had experienced a poor result from a right Total Knee Replacement years earlier and was seeking a means of improving function and minimizing her left knee pain resulting from arthritis. Cartilage does not have a nerve supply so scientists and clinicians have long sought a clear understanding of the pain generator in osteoarthritis. While there still is not a clear-cut consensus, many clinicians are looking at the bone marrow lesions seen on an MRI when taken of an arthritic joint as the possible cause of pain associated with arthritis.
In the case of my patient, the combined BMAC-Stem Cell procedure coupled with the subchondroplasty had resulted in a very satisfactory outcome and such maintains at this time to the best of my knowledge. What was unique about my patient was the use of Bone Marrow Concentrate-Stem Cells to serve as the catalyst to effect healing of the bone marrow lesions. Up until that time, surgeons were using a synthetic calcium phosphate material to fill the defects above and below a joint surface with a mandatory three months of protected weight bearing and six months of altered physical activity. The introduction of Bone Marrow Concentrate with Stem cells required 48 hours of crutch support and six weeks of restricted physical activity.
My patient who received media attention served to foster a debate in the medical device industry as to the superior methodology serving as an adjunct to a subchondroplasty. First came the initial trial using a subchondroplasty procedure and synthetic filler with the inherent need for prolonged altered function and assisted ambulation. Now there are several clinical trials in development pertaining to an arthritic joint and the minimally invasive, percutaneous subchondroplasty comparing the synthetic filler to the Bone Marrow Aspirate Concentrate-stem cell adjunct; with the latter used both inside the joint and in the adjacent subchondral bone.
Are your arthritic joint changes affecting both the cartilage and the supporting bone? Is the actual source of your joint pain, the supporting bone or bone marrow lesions adjacent to the hip, knee, ankle or shoulder? It would require a complete examination and review of X-rays and an MRI for me to answer the question and advance the most appropriate therapeutic recommendation. Could it be that the failure of a regenerative intervention wasn’t a failure of the stem cells but rather a failure to address the real pain generator, subchondral bone?
Call for an assessment 312 475 1893 and I will try to answer that question.
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, Subchondroplasty, treatment, Ultrasound Guided Injection
Cartilage damage may result from trauma, repetitive motion/impact, abrupt abnormal weight bearing, fractures, wear/degeneration, joint infection, meniscectomy, friction/abrasion due to abnormal joint alignment, inflammatory diseases or a genetic predisposition to name a few reasons. The primary symptoms are pain, loss of motion and functional impairment.
As a form of connective tissue that is very primitive from an evolutionary standpoint, cartilage does not lend itself to intrinsic repair. All the attributes required for healing, while present in bone, are missing in cartilage including blood vessel supply, pain fibers, regenerative cells, fluid balance, and a rich source of nutrition. The cartilage in your joint is not populated by metabolically active cells nor is the chondrocyte capable of positively influencing its own environment. In keeping with all of the principal shortcomings of cartilage, chondrocytes do not replicate after age 40 and cannot migrate.
Because articular cartilage damage from any of the aforementioned causes is permanent and progressive, it is paramount that intervention takes place early in the degenerative process or soon after injury. The likelihood of a successful, enduring repair or restoration diminishes as generalized cartilage deterioration progresses.
There are many palliative interventions available such as weight loss, non-steroidal anti-inflammatory medication, shoe wedges, off-loader braces, cortisone injections, gels/visco-supplementation, and most recently, amniotic fluid concentrates. Missing though from all of these options is the regenerative potential. Bone Marrow Aspirate Concentrate not only introduces regenerative potential via adult mesenchymal stem cells, it is a huge resource for anti-inflammatory molecules termed cytokines. Equally important though are the extracellular vesicles (exosomes) termed growth factors. What about adipose derived stem cells and cultured stem cells?
While adipose tissue contains stem cells, the latter are not available unless liberated from their surroundings. An enzyme, collagenase has been the necessary ingredient but the use of collagenase is interpreted as tissue manipulation and thus not allowed by the FDA. While there was an introduction last July of a mechanical means of liberating stem cells from fat graft harvest, there are no outcomes as of yet to support said alternative. At the same time, while adipose derived stem cells have been used outside of the US, there are no studies indicating better outcomes with adipose derived cells as compared to bone marrow derived stem cells. The remaining question at this time is whether the results of cultured stem cells are superior to Regenexx SD outcomes. While there is anecdote, we have no Evidence Based Information to help guide Clinical Appropriate Use Criteria.
With all the above written, I am done for today; if you are still unclear or uncertain, call the office for an appointment.
847 390 7666
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, FDA, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedics, Osteoarthritis, Pilot Study, Regenerative, Regenexx, Regenexx-SD, stem cells, treatment