Archive for category Regenerative Pain Center
From Anecdote to Clinical Trial
Posted by Mitchell B. Sheinkop, M.D. in Regenerative Pain Center on December 28, 2011
If you watched the Los Angeles Lakers play the Chicago Bulls over the Christmas weekend, you would have heard the story repeated many times during the broadcast of how Kobe Bryant had traveled to Germany for a Platelet Rich Plasma treatment for his arthritic knee and how PRP is not available in the United States. My congratulations to Kobe Bryant and his doctors, it looks like the treatment worked although the Bulls did win. He played well and there was no visible sign of the bone-on-bone arthritic knee affecting him. To correct the announcers though, you should be aware that platelet rich plasma injection, not unlike that used in the case of Kobe Bryant, is widely available in the United States and FDA approved. Since April of this year, I have personally treated 28 patients with Platelet Rich Plasma including the knee, hip and shoulder. Improvement in arthritic symptoms and increased function has been observed in about 70% of those patients so far. That’s a reasonable improvement for arthritic impairment but is there something better? Might a non-surgical stem-cell treatment for people suffering from knee pain due to common injuries or other degenerative problems be a substitute treatment for arthroscopy or total knee replacement?
Original Article
Incidental Meniscal Findings on Knee MRI in Middle-Aged and Elderly Persons
Martin Englund, M.D., Ph.D., Ali Guermazi, M.D., Daniel Gale, M.D., David J. Hunter, M.B.,B.S., Ph.D., Piran Aliabadi, M.D., Margaret Clancy, M.P.H., and David T. Felson, M.D., M.P.H.
N Engl J Med 2008; 359:1108-1115September 11, 2008
Results
The prevalence of a meniscal tear or of meniscal destruction in the right knee as detected on MRI ranged from 19% among women 50 to 59 years of age to 56% among men 70 to 90 years of age. Among persons with radiographic evidence of osteoarthritis, the prevalence of a meniscal tear was 63% among those with knee pain, aching, or stiffness on most days and 60% among those without these symptoms. The corresponding prevalence among persons without radiographic evidence of osteoarthritis was 32% and 23%. Sixty-one percent of the subjects who had meniscal tears in their knees had not had any pain, aching, or stiffness during the previous month.
Conclusions
Incidental meniscal findings on MRI of the knee are common in the general population and increase with increasing age.
Because of the aforementioned scientific study, I have determined the following Inclusion criteria for the Bone Marrow Concentrate Pilot Study
1. Age over 50. For patients with an osteoarthritic defect on MRI
2. Near normal knee alignment
3. Symptoms referable to the cartilage defect:
Swelling
Pain
Giving way
Locking
Crepitation
4. Early OA with no evidence of inflammatory arthritis
5. >2mm residual joint space on X-ray
6. Unicompartmental osteoarthritis
a. ROM >-10 to 110
b. Mechanical axis <12 degrees varus or valgus
c. Minimal involvement of patella femoral joint
d. No >2-3mm laxity in any plane
To find out if you qualify for the study, call and make an appointment. For those who don’t qualify for inclusion in the Pilot Study, you still may be a candidate for Bone Marrow Concentrate treatment of your arthritic joint.
Mitchell B. Sheinkop, M.D.
1565 N. LaSalle Street
Chicago, Illinois 60610
847-390-7666
The Regenerative Pain Center
Posted by Mitchell B. Sheinkop, M.D. in Regenerative Pain Center on December 13, 2011
The Regenerative Pain Center
There is a very unique challenge concerning how to manage the effects of aging and the resulting impact on musculoskeletal well-being and continued participation in sports-from the weekend to the master athlete. Better understanding of the basic science of aging allows for better management of the physiological and biological issues and challenges facing the athletic baby boomer patient. The major problem as we age is weight gain despite a high level of activity and the same nutritional patterns as when we were younger. One must be aware that the body’s Resting Metabolic Rate (RMR) comprises 60-75% of daily energy expenditure and that RMR decreases 20% from childhood to retirement. The second major contribution to athletic decline is degenerative arthritis
The Basic Science of Aging :Implications for the Male and Female Master Athletes
We all must recognize the normal physiologic effects of aging and how our activities of daily living, work related undertakings, recreational enjoyment, and participation in sports are impacted. Are there appropriate non-operative treatment plans for patients with traumatic, degenerative, and arthritic conditions, particularly related to the knee, hip, shoulder and spine that might allow you to postpone or even avoid a joint replacement?
To address these issues, the Regenerative Pain Center (RPC) will open its Chicago doors next week with offices in Lincoln Park and Des Plaines; the sole purpose being an attempt at pain control through regenerative medicine. Is the timing right; is it premature? Last week, Dr. Jon Lapook on CBS NEWS Healthwatch reported on the experimental treatment Platelet Rich Plasma therapy, the procedure that appears to help heal a muscle, tendon or joint injury without surgery. Assessing the value of PRP therapy may be viewed at
http://www.cbsnews.com/video/watch/?id=7390747n&tag=mncol;lst;1
On page 3 of The Chicago Tribune/Business/Section 2/Friday, December 9, 2011 FOCUS STEM CELL THERAPY featured “Investors poised to pounce on a commercial breakout”. ”Early clinical trial successes of dozens of treatments bring hopes some will hit the market in 5 years.” To paraphrase, the promise of stem cells lies in their ability to repair tissue and reduce inflammation. While the Food and Drug Administration has not yet approved unfounded claims of success with regenerative menu of offerings, the FDA does not interfere in the clinical practice of medicine as long as there are no unsubstantiated claims made. Next week, I will announce a Pilot Study using autologous bone marrow concentrate for the treatment of patients impacted by arthritis made possible because of the Regenerative Pain Center.
Mitchell B. Sheinkop, M.D.
1565 N. LaSalle Street
Chicago, Illinois 60610
847-390-7666
PRP, Stem cells or Surgery
Posted by Mitchell B. Sheinkop, M.D. in Platelet Rich Plasma, Regenerative Pain Center, Stem Cells, Uncategorized on October 4, 2011
To operate or not to operate?
Although Joint Replacement Surgery is a fairly predictable and cost-effective intervention for severe osteoarthritis of a major joint, it is not necessarily the treatment of choice for everybody. There are issues surrounding the decision-making process for surgeon and patient. Treatment should begin with most basic options and progress to the more involved as not all treatments are appropriate for every patient. Not everybody gets better after a total hip or total knee replacement. An important minority estimated at 10%-20% does not improve or are made worse by surgery. Then there is the population of patients who have associated conditions, co-morbidities, which prevent them from undergoing a surgical procedure without severe medical risks.
Try Nonsurgical Therapy First
While orthopedic surgery is based on allopathic medicine, that is the scientific process; the key to good decision-making about whom should have a joint replacement should be a holistic approach. Weight Reduction is paramount; anything greater than a BMI of 25.5 will result in excess loading of your hip and knee. Activity modification is strongly recommended using a bike and the swimming pool for exercising, Low-impact aerobic fitness, range of motion and flexibility exercises, muscle strengthening, and core strengthening. I find a patellar stabilizing knee sleeve to be very valuable, the one with the hole in the center. Acupuncture, glucosamine and chondroitin sulfate still are homeopathic. While there seems to be a greater than 50% positive response to visco-supplementation in the knee, the American Academy of Orthopedic Surgeons will not endorse this approach. There is no question that intra-articular corticosteroids offer short-term pain relief both in the hip and the knee.
Arthroscopy
Not advised for debridement of an arthritic hip. The same holds in the primary diagnosis of symptomatic osteoarthritis of the knee. On the other hand, there is a place for partial meniscectomy or loose body removal when the primary symptom arises in the presence of osteoarthritis.
Orthobiologics (PRP and Stem Cells)
We do not yet know exactly who may benefit from platelet concentrate or bone marrow concentrate and which factors are most critical in assuring the best possible outcome. Even the exact scientific explanation for how stem cells really work is still in the works. Preoperative severity of arthritic disease is probably most important. At this time, the decision to undergo an ortho-biologic procedure is about balancing potential benefits against potential risks. Given the fact that the biologic is autogenous and confined to a major joint, the significant risk is infection; that’s the risk of any invasive procedure and exceedingly rare to date. The case studies suggest that the new world of stem cells is worth consideration before a joint replacement
Treating knee arthritis via joint preservation and regeneration
Posted by Mitchell B. Sheinkop, M.D. in knee, Osteoarthritis, Regenerative Pain Center on June 21, 2011
Musculoskeletal Care of the Mature Patient
There is a very unique challenge concerning how to manage the effects of aging and its impact on musculoskeletal well-being and continued participation in sports-from the weekend to the master athlete. As the majority of patients I see come for impairment of the knee, that will be the subject of this Blog. No matter which joint though, the major problem as we age is weight gain despite a high level of activity and the same nutritional patterns as when we were younger. One must be aware that the body’s Resting Metabolic Rate (RMR) comprises 60-75% of daily energy expenditure and that RMR decreases 20% from childhood to retirement. So too, just as there is a tendency to gain weight, there also is the reality of continued loss of muscle mass with aging. Even if your weight remains unchanged, your percent body fat will increase. If you don’t believe me, take your clothes off and look in the mirror. To make matters worse, joint cartilage doesn’t physiologically reproduce after age 40, so whether it be genetically programmed or from injury, the cartilage loss is historically irreversible.
All bad news so far about athletics with aging but the vicious cycle can be broken. First of all, try to be as thin as possible while still maintaining good health. Second, you need to strength train in addition to aerobic and anaerobic conditioning. That’s where cross training is exceedingly helpful. When your knee hurts, water based exercising is the fix. When you can’t run, biking is the approach. From my perspective, when the over the counter analgesics and anti-inflammatories aren’t affective, the first line of approach is an intra-articular cortisone injection coupled with a prescription for an anti-inflammatory and physical therapy. Bracing is beneficial starting with an over the counter support. Also consider an orthotic in your shoe to level your running and walking and thereby correct force transmission to the knee. The next step in magnitude for the arthritic knee is the unloading brace (orthotic) with or without the electro-stim adjunct. If the intra-articular cortisone injection benefit lasts four months, it may be repeated a total of three times in a year. If not, visco-supplementation is the next option. This injection of hyaluronic acid has proven very helpful in managing knee arthritis. The latter series of injections may be repeated twice a year at six-month intervals. While five years ago, the visco-supplementation series required up to five injections per series, now the demand is one to three visits owing to advances in science.
OK, you have done all these things and the pain and impairment relief are no longer affective, now what? Platelet Rich Plasma is the latest and maybe the greatest; we shall see. My colleagues and I are using PRP with early very positive early results. Caution, up until the usage of Platelet Rich Plasma, treatments were covered by private indemnification and Medicare either all or in part. PRP is an out of pocket expense. Naturally, the final step before a joint replacement will be stem cell based and we’re working toward that end. If you can’t wait, have a total knee replacement; there are inherent risks that are permanent so be a well-informed consumer. If you are able to wait, take my prescription and follow the algorithm for TREATING KNEE ARTHRITIS VIA JOINT PRESERVATION AND REGENERATION.
Rejuvenative Cellular Medicine Anecdotes
Posted by Mitchell B. Sheinkop, M.D. in Platelet Rich Plasma, Regenerative Pain Center, Stem Cells on March 1, 2011
Musculoskeletal Care of the Mature Patient
I am off skiing this week in Colorado so I thought I would let my readers entertain themselves with some anecdotes from the web.
Regenexx Knee Patient Finishes the Ironman
“This 68 year old went from being told he needed a knee replacement, to successfully resuming his triathlon career with a Hawaii Ironman finish! After the Regenexx-C procedure, he was able to complete the 2.4-mile swim, 112-mile bike ride and 26.2 mile run. You may read more at www.regenexx.com
10 Years of Knee Pain Erased
Patient underwent the Regenexx-C procedure to deal with osteoarthritis of the knee.
“I’ve had pain in both of my knees for the last 10 years. It began when I was in the Army, and I was finding it harder and harder to do all the lifting, running and physical exercise that I needed to do. I went to the Army doctors, who told me I had osteoarthritis in both knees, but there wasn’t much I could do. Even the Army medical review board simply remarked in my record that I couldn’t do some of the physical requirements because of my knee pain, but they didn’t offer any solutions.”
“Since then, I’ve been doing lot of physical therapy, but that only helps so much. I’m not much of a medicine taker, so I usually just worked through the pain. I’d have good days and bad days, but the pain was always there.”
“We did the right knee in March 2007. I was off my feet for about an hour after each of the treatments, but that was it. No long recovery time, no time off from work – it was great. The cartilage began to grow back, and the knee was feeling much better, so we did the left knee in October. Since about two weeks later, I haven’t had any pain at all in either knee for the first time in 10 years. It’s fantastic.” You may read more at www.regenexx.com
Hip Arthritis 2 Year Stem Cell Results Update
“A 50 year old woman was treated 2 years ago for moderate hip arthritis with an injection of her own cultured stem cells. The patient at that point had bone cysts, but good cartilage remaining. Two years later she reports good relief for the past 24 months with the hip feeling much more fluid. At this point, her hip is just beginning to feel less fluid with more stiffness, so she would like an updated injection. She was very good at growing stem cells in culture (some patients aren’t as prolific a cell grower as CM), so she has cells in cryo preservation (“on ice”), which can be used for this next injection (without having to draw more cells and re-culture). CM brings up an important point in our hip data. First, hip patients tend to have less relief on average than knee arthritis patients. This will be part of an upcoming publication, but we believe this may be caused by technical issues with getting stem cells to attach to the right areas of the hip when cells are placed through injection. CM had great range of motion when she was injected (often not the case with hip arthritis patients) and as a result, we got excellent placement of cells. The second observation in our data is that hip patients have less duration of effect than knee patients. This is likely due to the reasons above. Finally, since we only have 3-4 year follow-up data on a reasonable number of patients, any or all of our patients may need re-injections at some point in the future as a stem cell “booster shot”. You may read more at
Tissue Genesis awarded joint repair grant
www.xcell-center.com/patient-stories/arthritis
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More about rejenerative cellular medicine
Posted by Mitchell B. Sheinkop, M.D. in Platelet Rich Plasma, Regenerative Pain Center, Stem Cells, Uncategorized on February 22, 2011
Centrifugal force is used to create platelet-rich plasma. Solid blood elements (white blood cells, red blood cells, and platelets) are separated via centrifugation due to variations in size and density.
Because of the FDA mandated prohibition on the maximal manipulation of stem cells and the rigorous enforcement crackdown this past September, those clinical propnents of autologous bone marrow derived adults mesenchymal stem cells have not been able to continue with their respective therapeutic initiatives. As a result, poorly informed patients are seeking Platlet Rich Plasma.
PRP an unproven options, say experts
An international group of orthopaedic surgeons, clinician scientists, and researchers concluded during the American Academy of Orthopedic Surgeons annual meeting this past week that, for many orthopaedic conditions, administration of platelet-rich plasma (PRP) may be an option, but its efficacy is unproven. The participants of the 2011 PRP Forum also endorsed the development of standards in the manufacture of PRP, noted that PRP may be contraindicated in some conditions, and called for the establishment of a study group to follow up on the other recommendations resulting from the session.
Attendees discussed the applicability of PRP in the following areas:
- treatment of acute soft-tissue injuries, such as Achilles tendon rupture and rotator cuff repair
- chronic tendinopathies such as plantar fasciitis or medial/lateral epicondylitis
- augmentation of soft tissue or bone such as in spinal fusion
- treatment of cartilage defects such as those resulting from osteochondral lesions or osteoarthritis.
All PRPs are not the same
All PRPs are not the same and the treating physicians may not be aware of what they are putting in the patient. Although PRP is a concentrated, autologous preparation developed from your own blood, some concentrations may contain double the number of platelets while others may contain five or ten times the number of platelets. The proportion of white blood cells, growth factors, and other compounds such as thrombin can also affect the compound.
If the truth be told, we don’t know how PRP works.. Most of the published literature on the efficacy of PRP in treating orthopaedic conditions that range from acute rotator cuff repair.
More on Rejuvenative Cellular Medicine
Posted by Mitchell B. Sheinkop, M.D. in Regenerative Pain Center, Stem Cells, Uncategorized on February 7, 2011
Musculoskeletal Care of the Mature Patient
Might stem cell management offer breakthrough, non-surgical treatment options for people suffering from moderate to severe joint, tendon, ligament, or bone pain due to injury and other conditions? That’s the promise of those worldwide with experience. Is the time right to pursue stem cell therapy in orthopedic injuries and arthritis closer to home in terms of research presentations, publications, and academic achievements? Let me put things in perspective for your consideration.
You may become better informed by looking over my weekly blog postings for the past six weeks (http://www.sheinkopmd.com/archives) Rejuvenation cellular therapy is being offered around the world including here in the US. The restriction in the US has to do with “minimal manipulation” of the cells. Since bone marrow derived stem cells are insufficient in concentration, they have to be maximally manipulated via growth in culture and treatment with growth factors. The leader in orthopedic technology has been Regenexx out of Colorado but the FDA stopped their maximal manipulation of aspirate from the posterior superior iliac spine region, manipulation and subsequent injection after a four to six week delay. That delay necessitates a second visit.
Regenexx has about a thousand case experience over the last several years but can no longer operate as such in the USA. The company is looking to license operations outside of the USA. (http://www.regenexx.com/) The same holds for Celling Technologies in Texas (http://www.cellingtechnologies.com/). Like Regenexx, they are looking to relocate outside of the USA because of oversight by the FDA concerning their bone marrow aspirate program.
Enter adipose derived stem cells. While less is known about adipose derived stem cells and arthritis, the advantage of adipose derived stem cells is the stromal vascular fraction (SVF) which has concentrated growth factors in addition to the stem cells. Second, the adipose tissue that is derived from liposuction contains unlimited quantities of cells and hence, need not be manipulated. What Cytori (http://www.cytoritissue.com/) (San Diego) and Tissue (http://www.tissuegenesis.com/) (Honolulu) have in common is the absence of a need to manipulate cells other than concentrating in a centrifuge for an hour and immediate introduction into the joint of concern. Incidentally, adipose derived stem cells are very applicable to wound healing and diabetic revascularization of a limb as well, according to published accounts. While the cost of the stem cell harvesting and processing is a patient out of pocket expense, the cost of the facility use, the fluoroscope or ultrasound assisted injection procedure and the payer covers the injection. The cellular rejuvenation procedures could be used to treat and avoid surgery for rotator cuff injuries, intractable lateral epicondylitis, osteoarthritis of the hip, avascular necrosis of the hip, labral hip injuries, knee ligament injuries, avascular necrosis around the knee, degenerative arthritis of the knee, osteochondral injury of the knee, non-union of fractures and osteotomies, osteochondral lesions of the talus, hallux rigidus, etc., etc., etc.
My questions for the reader, if you have an arthritic condition that will require a joint replacement in the next two to five years, for the potential of delaying or possibly avoiding that surgery, would you invest for rejuvenative cellular care? Is it time for me to establish a treatment program-clinical trial?
Off-label use of orthopedic drugs and devices
Posted by Mitchell B. Sheinkop, M.D. in Regenerative Pain Center on September 20, 2010
Musculoskeletal Care of the Mature Patient
A patient came in to my office this past week and asked me about a series of visco-supplementation injections for her hip. She had responded reasonably well last year to a series of such injections in her arthritic knee and wanted to enjoy relief of arthritic hip symptoms by a similar treatment protocol. I explained to the patient that visco-supplementation for the hip had not as yet been approved by the FDA, though it is a standard of care for the arthritic knee in many clinical settings. I have to make a decision between what is in the best interest of my patient and the regulatory medical device oversight dictates of the United States Food and Drug Administration. Is the standard of patient care out in front of regulatory device approval?
My conflict as to whether to cross the line between approved indications and patient needs is not new. If you have practiced as long as I have, there is little that I haven’t experienced as so much of what is marketed as new falls under the category“ been there, done that”. In 1979, I was involved in the first clinical study in the United States along with two other co-investigators of a new type of hip prosthesis, the cement-less hip. Now the standard of care in 95% of hip replacements done in the U.S., in 1979 we navigated uncharted waters as the 1976 Safe Medical Device Act did not regulate physician-directed off-label use that is in the best interest of the patient. The primary determinant I believe is ethical in that If I feel I can achieve a better result with the use of an off-label device or drug when contrasted to one that is FDA approved, with informed consent of the patient and a full scientific knowledge of the possible complications of the yet unproved treatment modality, I will make the decision with the patient.
