Jul 19, 2012
Patrick Henry in 1775? No, Dr Mitchell Sheinkop in 2012. Last Monday, I evaluated a new patient, a 32 year old woman with steroid related avascular necrosis of her humeral head. On Wednesday, I did a bone marrow aspirated stem cell concentrate procedure in an attempt to prevent the dead femoral of a 31 year old male from collapsing and going on to secondary arthritis. In the second scenario, steroids again were the culprit. The young woman had required steroids as part of a chemotheraputic protocol for ovarian cancer.
The young man had been using steroids long term for asthma. Alcohol abuse, trauma( fracture in proximity to a joint or dislocation of a joint), and high dose steroids are the most common reasons for loss of blood supply to a femoral head, humeral head or lower end of the femur. Until the advent of Regenerative Medicine, with little exception, management of avascular necrosis basically consisted of measures to provide comfort until progression of the disease leads to a joint replacement. Enter the possibilities of stem cell adjunct to stimulate new blood supply, prevent progression , and stimulate healing.
As in all of Regenerative Medicine, the statistical evidence for successful outcomes using stem cells to influence creeping substitution is not available to provide guidance. On the other hand, there is animal based evidence that it works. We know that stem cells affect bone healing after fracture nonunion and improve success following spinal fusion by promoting the Ingrowth of new blood supply. I think it is worth clinical investigation. Actually, there are published reports regarding core decompression and bone grafting in humans. What about core decompression and stem cells?
My approach in attempting to influence the natural history of avascular necrosis with adult mesenchymal bone marrow derived autogenous stem cells is based on appropriate patient selection. The X-ray and MRI must confirm the joint has maintained its geographic kconfiguration and the cartilage joint space must be maintained. Whereas in arthritis, the bone marrow concentrate first and foremost relieves pain by controlling the chronic inflammation. In avascular necrosis, we are attempting to influence angiogenesis ( new blood supply) and influence bony healing. As concluded in an article published in the Journal of Bone and Joint Surgery,implantation of autologous bone marrow derived mononuclear cells appears a safe and effective treatment for early stages of osteonecrosis of the femoral head.
Mitchell B. Sheinkop, M.D.
847 . 390.7666
1565 N. LaSalle Street . Chicago . Illinois . 60622
Jun 28, 2012
This past weekend, I had chance social encounters with two patients, not mine, unhappy with the outcome of their joint replacements. Their painful prostheses behaved no different than the patient with chronic osteoarthritis: swelling, limited motion, limp. Might stem cell management with an appropriate postoperative rehabilitation regimen have given the joint a better chance at remodeling and avoided a painful total joint?
We continually seek better mechanical and biologic approaches to osteoarthritis prevention and treatment. It is now known that following high-energy joint injury, articular remodeling can be promoted through distraction and motion of cartilage surfaces. Papers presented at the International Cartilage Repair Society -Montreal-May 12-15 confirmed that altered motion and loading might really make a difference in treating end stage osteoarthritis. Equally important though, what about the pain generators in OA?
- Loss of articular cartilage (bone on bone)
- Synovitis (chronic inflammation)
- Flexion contractures (loss of motion/capsular compliance)
It is paramount that the physician managing your arthritis try to understand all pain generators in a joint and optimize the joint environment prior to surgery, during the surgery or using stem cells in lieu of surgery. First, the joint volume and capsular compliance need be addressed. Second, the inflammatory burden need be minimized. Last, mal-alignment need be neutralized. I will stress over and over that the data to support my treatment algorithm must be increased via outcome surveillance. That data can only be gathered through clinical practice. Based on what we have learned in managing arthritis with stem cells over five years, there is data to support the reversal in loss of articlular cartilage, eliminate inflammation and increase range of motion.
Prior to undergoing a bone marrow aspirate concentrate procedure, the patient is directed to physical therapy. In the case of a knee, an offloading brace is prescribed. After the procedure, protected weight-bearing, range of motion exercising and gradual strengthening is introduced. The stem cells altering the bio-immune environment inside the joint might be the alternative at eliminating pain generators and postponing or even avoiding the joint replacement
Mitchell B. Sheinkop, M.D.
312-475-1893 or 312-475-1893
1565 N. La Salle Street . Chicago . Illinois . 60610
Tags: Hip Replacement, Interventional Orthopedics, Microfracture surgery, Orthopedic Surgeon, Orthopedics, Regenerative Pain Center, stem cells
Jun 12, 2012
Orthopedic Care of the Mature Athlete
Will stem cells work in relieving the pain from an arthritic joint; that is the question? A patient read my blog and called to discuss his experience with the orthopedic surgical community. Since his is not the first time I came across opposition to Regenerative Medicine, I thought I would focus on that resistance this week.
An orthopedic surgeon is just that, a surgeon. Usually trained with a major emphasis on surgical technique and evidenced based medicine, it is difficult to foster change within the orthopedic community. I should know as I practiced orthopedic surgery for 38 years developing that surgical technique in the joint replacement sub specialty and doing the clinical research that led to the evidence forming the basis of modern hip and knee replacement surgery. During that era, I also noted the failures of joint replacement and other adverse outcomes so I started seeking an alternative to joint replacement, basically a biological arthroplasty.You better believe the orthopedic community has not rapidly adopted this latter concept in theory. Yet, orthopedic surgeons have been attempting cartilage restoration for over seven years and actually informing the surgical candidate about stem cell treatment of arthritis every time they performed an arthroscopic micro fracture. The Arthroscopic Package for the injured or arthritic joint includes micro fracture. The explanation behind the technique of micro fracture is that one is allowing a patent’s own adult mesenchymal stem cells to migrate from within the bone marrow to the joint by creating multiple small holes in the diseased cartilage communicating with the marrow. The only problem with the hypothesis, no matter how enticing, is that by time a patient reaches the age of 40 to 50, there is no active marrow remaining near the knee and very little remaining at the hip or the shoulder. Why not then, harvest bone marrow from the pelvis where it is plentiful at any age, filter out the stem cells and concentrate them followed by reinjection after the micro fracture? It makes all the sense in the world, is worthy of clinical trial and outcomes surveillance, and does not make the Arthroscopic Package much more complex.
In my attempt to overcome the negative reaction of the orthopedic clinical community to my Regenerative Medicine initiative increasingly made known to my patients, I sought the guidance of the leader of a think tank and a mentor, Chef.
Dr Sheinkop: “How do I overcome resistance to my procedure of the future when the orthopedic surgeon has been using it for over five years?”
Chef: ” Forget all that genetic engineer whoosa-fudge…….if you want to combine a pig and an elephant, just get them to make sweet love”
Dr Sheinkop: “The orthopedic surgical community will never accept a non operative approach to the management of arthritis if it threatens a decrease in the number of procedures.”
Chef: “Sure they would but you’re gonna have to get’em in the mood”
In August, I have been invited to speak before an orthopedic audience for the first time to share my earliest observations regarding response to stem cell management of arthritis. Two weeks ago, I did my first case; last Wednesday, I did three. It won’t be a series on which to report but I certainly will have something new to share. The Reality show to be continued.
Tags: Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Hip, Interventional Orthopedics, Knee, medicine, Orthopedic Surgeon, Orthopedics, Pain Management, Regenerative Pain Center, stem cells
Jun 5, 2012
Orthopaedic Care of the Mature Athlete
I had not heard from the hip patient I had written about last week, the “First Time “, so I asked my assistant to call him fearing the worst. “I am doing really great.” “My pain was at 90% and now is 10%” “My back is still a little sore but I am moving around without a problem and back to work”. “I am very happy”. (To be continued)
This past Monday night, my wife and I attended the pre-opening of a new Italian restaurant in our neighborhood sponsored by The MidNorth Organization. We sat down next to a longtime neighbor and his wife, the former, a tax and zoning attorney.
Question: “So are you retired from Orthopedics?”
Answer: “I retired from surgery almost three years ago, but I continued my outpatient practice while I envisioned, studied and trained for a new approach to orthopedic disease, Regenerative Medicine”.
Question: “What’s that.”
Answer: “It is a minimally invasive approach, in my case, to the management of arthritis with stem cells taken from your own body. After all those years of doing joint replacement, I am working at postponing that need, maybe eliminating that need for a joint replacement”.
Question: I watched a piece on 60 minutes about stem cells and schemes, is it ethical?”
Answer: “What you saw on 60 Minutes was about charlatans, criminal opportunists victimizing desperate families.”
Question: “Is it legal?”
The procedure is compliant with CFR 21 Part 1271
Question: “What do you think about this? My client was a big time real estate developer flying high and building to the sky in Chicago until the crash of the real estate market and now he is almost broke. He has a very arthritic hip because of which he had to quit his passion for bike riding. He no longer had insurance and could not afford the approximately $50,000 out of pocket cost of a joint replacement. He went on line, found a stem cell program in Colorado and last year, underwent a concentrated bone marrow aspirate procedure for his hip at a relatively low cost. I thought it was a hoax, a scam”
Answer: “What was the result?”
Question: “He had always biked the Outer Drive in Chicago, the Sunday of Memorial Day weekend when they hold “Bike The Drive”. Last year he had to quit because of his hip. This year he was able to ride for 15 miles. I don’t know what to think?”
Agony or ecstasy, scam or the future, Yin or Yang? That is why my clinical approach is under the auspices of an FDA approved Clinical Pilot
Mitchell B. Sheinkop, M.D.
312-475-1893
1565 N. LaSalle Street
Chicago, Illinois 60610
May 22, 2012
Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis
This study is currently recruiting participants.
Verified May 2012 by Regenerative Pain Center, Illinois
First Received on May 14, 2012. Last Updated on May 16, 2012 History of Changes
|
Sponsor:
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Regenerative Pain Center, Illinois |
|
Information provided by (Responsible Party):
|
Regenerative Pain Center, Illinois |
|
ClinicalTrials.gov Identifier:
|
NCT01601951 |
Purpose
The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have “regenerative” properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.
Inclusion Criteria:
- Subjects must be scheduled for an autologous bone marrow hip or knee injection
- Subjects must have a diagnosis of hip or knee osteoarthritis
- Subjects must be between the ages of 18 and 85
- Subjects must be willing and able to sign Informed Consent
- Subjects must be willing and able to return for scheduled follow-up evaluations
-
Exclusion Criteria:
- Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
- Subjects for whom baseline data is not available
| Study Type: |
Observational |
| Study Design: |
Observational Model: Cohort
Time Perspective: Prospective |
| Official Title: |
Autologous Bone Marrow Concentrate Database Outcomes Research Project |
Resource links provided by NLM:
MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources
Further study details as provided by Regenerative Pain Center, Illinois:
Primary Outcome Measures:
- Visual Analog Pain Scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
Change in subjective pain measure
- Harris Hip Score or Knee Society Score [ Time Frame: Baeline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
Change in subjective pain, function, functional activity measurement and a clinical physical exam
- Physician Global Assessment [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
Change in physician rated disease activity measurement
Secondary Outcome Measures:
- Radiologic [ Time Frame: Baseline, 1 year ] [ Designated as safety issue: No ]
Radiographic changes of the hip or knee
| Estimated Enrollment: |
15 |
| Study Start Date: |
April 2012 |
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Groups/Cohorts
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Assigned Interventions
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| Hip Osteoarthritis |
Other: Procedural, Bone Marrow concentrate injection
This is strictly data collection and outcomes based. The procedure is not part of this study |
| Knee Osteoarthritis |
Other: Procedural, Bone Marrow concentrate injection
This is strictly data collection and outcomes based. The procedure is not part of this study |
Eligibility
| Ages Eligible for Study: |
18 Years to 85 Years |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
| Sampling Method: |
Non-Probability Sample |
Study Population
Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection
Criteria
Inclusion Criteria:
- Subjects must be scheduled for an autologous bone marrow hip or knee injection
- Subjects must have a diagnosis of hip or knee osteoarthritis
- Subjects must be between the ages of 18 and 85
- Subjects must be willing and able to sign Informed Consent
- Subjects must be willing and able to return for scheduled follow-up evaluations
Exclusion Criteria:
- Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
- Subjects for whom baseline data is not available
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601951
Contacts
Locations
| United States, Illinois |
| Regenerative Pain Center |
Recruiting |
| Des Plaines, Illinois, United States, 60016 |
| Principal Investigator: Mitchell Sheinkop, M.D. |
Sponsors and Collaborators
Regenerative Pain Center, Illinois
Investigators
| Principal Investigator: |
Mitchell Sheinkop, M.D. |
Regenerative Pain Center |
More Information
No publications provided
| Responsible Party: |
Regenerative Pain Center, Illinois |
| ClinicalTrials.gov Identifier: |
NCT01601951 History of Changes |
| Other Study ID Numbers: |
MM-01 |
| Study First Received: |
May 14, 2012 |
| Last Updated: |
May 16, 2012 |
| Health Authority: |
United States: Institutional Review Board |
Keywords provided by Regenerative Pain Center, Illinois:
Osteoarthritis
Stem Cell Injections
Bone Marrow
Autologous |
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis |
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 20, 2012
Mitchell B. Sheinkop, M.D.
312-475-1893 or 312-475-1893
1565 N. LaSalle Street . Chicago . Illinois . 60610
May 9, 2012
Introduction and background
While the benefits of total hip replacements are numerous, there is a known incidence of associated pain leading to early revision. Have attempts at improving the prosthetic implant, shortened lengths of hospital stay, minimally invasive procedures and metal on metal bearings been a process of revolution or as in the case of Gulliver, devolution?
The goal of the surgeon has historically been pain relief and a 20-year plus satisfactory outcome when performing a total hip. More recently, survivorship prioritization seems to have been replaced by restoration of hip anatomical geometry, thereby optimizing muscle tension and strength, equalization of leg lengths, and enhancement of hip stability all via modularity. The newer generations of prostheses have been designed in an attempt to facilitate and accommodate the latest fads in surgical approaches so as to lessen the scar length, perhaps minimize muscle damage-still a matter of debate-and return the patient to full activity status in days or weeks rather than months.
I just received an AMA alert that by 2030, 42% of Americans will be obese. Short incision, less hospital stay, prompt return to activity, who are we kidding? Lets look more closely at the cost of supposed progress in the newest prosthetic designs.
Metal Fretting and Corrosion. This has been reported with cobalt chrome and cobalt chrome- titanium junctions. The more modularity and junctions between metals, the more potential metal debris generation. Metal on metal bearings produce small metallic wear debris. Furthermore, elevated blood serum ion levels and metal hypersensitivity resulting in an adverse local tissue reaction may occur with metal-metal articulate surface bearings causing premature failure due to osteolysis, aseptic loosening and pseudo tumor formation.
So what should you do and look for whether or not you are in pain after a total hip replacement?
Evaluation for infection-a screening serum ESR, C-Reactive Protein, and WBC. If any of these are abnormal, a hip aspiration need be performed.
Serum metal ion levels-serum chromium ion levels above 17ug/L and cobalt ion levels above 19ug/L suggest metallosis within the joint. Pseudotumors have been found at lower levels and are identified by ultrasound and CT scans. In the United Kingdom, the cut off level is 7 parts per billion (7ppb) chromium or cobalt.
Metal hypersensitivity-Nickel is the worst offender but chromium and cobalt may play a role. The problem is the area is still poorly understood with the only available testing including patch testing and the lymphocyte transformation test.
Radiographic analysis-Your physician will look for signs of loosening, osteolysis and pseudotumor formation
If you have a painful total hip replacement, you need an evaluation.
There is another consideration, postpone or avoid the replacement. Might Regenerative medicine and stem cell management, help control you pain and possibly postpone or even help avoid a total joint replacement?
Mitchell B. Sheinkop, M.D.
312-475-1893 or 312-475-1893
1565 N. LaSalle Street
Chicago, Illinois 60610
Tags: Hip Replacement, Osteoarthritis, Regenerative Pain Center, stem cells
