Archive for category Regenerative Pain Center

 

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:

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

Condition

Intervention

Hip and Knee Osteoarthritis Other: Procedural, Bone Marrow concentrate injection

 

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

 

Groups/Cohorts

Assigned Interventions

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

Contact: Mary Langhenry, PT 312-475-1896 mlanghenry@yahoo.com
Contact: Jennifer Kelly 312-475-2958 jkelly@weil4feet.com

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.

847-390-7666 or 312-475-1893
1565 N. LaSalle Street .  Chicago . Illinois . 60610

 

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Total hip replacement, what can go wrong

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.

847-390-7666 or 312-475-1893

1565 N. LaSalle Street

Chicago, Illinois 60610

 

 

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This Week’s Top Stories

 

British Hip Society recommends against use of stemmed, large diameter, metal-on-metal implants in primary total hip replacements.

Based on discussions held at its annual meeting, the British Hip Society (BHS) has issued a statement on the use of large diameter metal-on-metal bearing total hip replacements. BHS advises that stemmed, large diameter metal-on-metal primary total hip replacements using bearings of 36 mm or greater should no longer be performed until more evidence is available, except in properly conducted and ethically approved research studies. The advice does not apply to hip resurfacing. In addition, BHS endorsed guidance recently issued by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), calling for annual monitoring for the life of the implant, as a precautionary measure.

Other News 

FDA committee to discuss reports of joint destruction associated with anti-NGF drugs.

The U.S. Food and Drug Administration (FDA) plans to hold a meeting next week to discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development, along with safety issues possibly related to the drugs. Anti-NGF drugs are being developed for the treatment of chronic painful conditions such as osteoarthritis, chronic lower back pain, cancer pain, and other conditions. An advisory committee will be asked to determine whether reports of joint destruction represent a safety signal related to the anti-NGF class of drugs, and whether the risk-benefit balance for these drugs favors their continued development as analgesics.

Sheinkop meets with Regenexx in Colorado to evaluate new office based needle arthroscopic system

While it is true that I was skiing last week in Vail, while I vacationed, I still worked on assuming a leadership position in the new world of regenerative medicine. What I as an individual am able to contribute is my background and experience in research and clinical practice of treating arthritis with joint replacement surgery. Now I am dedicating myself as an orthopedic surgeon to avoiding or postponing joint replacement. When arthritis is debilitating and the X-ray is that of bone on bone, there is still an indication for a new hip or a new knee. But patient beware, there are restrictions inherent in a new joint. My life-long biking, skiing and fly fishing buddy, has relatively severe arthritis of his left knee. Yet he still can bike faster and ski better than me-I out fish him-because he has taken my counsel and postponed, maybe avoid a knee replacement via Regenerative Medicine.

To learn if you are a candidate for regenerative medicine, feel free to call

Mitchell B. Sheinkop, M.D.

847-390-7666 or 312-475-1893

1565 N. LaSalle St, Chicago, IL 60610

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Announcement!

We are pleased to announce that Dr. Sheinkop is a  member of the Regenexx Physician Network. 

Dr. Sheinkop is taking this week off so stay tuned for more information March 25, 2012

For an appointment please call

847-390-7666

1565 N. LaSalle St., Chicago, Illinois, 60610

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Saving umbilical cord blood

                                               

In the beginning, there was an umbilical cord. The blood in that cord was and is an invaluable source of stem cells that is unique to your body and family. These cells may be used to treat nearly 80 serious medical conditions at last count including leukemia, other cancers, and blood disorders. Cord blood stem cells are showing significant potential to treat conditions that have no cure today as juvenile diabetes and brain injury. Saving your baby’s or your grandchild’s cord blood secures the best treatment option for a healthy future.

According to the U.S. Department of Health and Human Services, “This revolutionary technology (regenerative medicine) has the potential to develop therapies for previously untreatable conditions. Examples of diseases regenerative medicine can cure include diabetes, heart disease, renal failure, osteoporosis, and spinal cord injuries. I am now ready to announce my personal entry into the new world of regenerative medicine in conjunction with the Regenerative pain Center by having joined the Regenexx network of physicians. I will start screening patients for bone marrow concentrate pilot study as of March 25th. The actual clinical process will be introduced at the beginning of May at the Regenerative Pain Center. There is as yet no assurance that bone marrow concentrate rich with autologous mesenchymal adult stem cells administered in to an arthritic joint will reverse arthritis or even stop progression but with the anecdotal observations around the country, I believe that as an orthopedic surgeon, I might or could be able to delay or avoid a joint replacement. Our pilot study will be the first step. In order to qualify, a patient will need to meet certain criteria determined by history, physical examination, X-ray and MRI. At times, a diagnostic out patient arthroscopic examination or prior treatment may be part of the program. For those who don’t qualify for the study, the patient may still seek treatment with a self-pay alternative.

Transplant medicine uses stem cells to help treat serious diseases, such as cancers and blood disorders. Regenerative medicine is a new and rapidly advancing area of medicine focusing on developing treatments using stem cells to repair damaged tissues and organs. The estimates to date that someone in your family will use stem cells in a lifetime include:

Transplant Medicine: 1 in 217

Regenerative Medicine: 1 in 3

I am thrilled to announce my entry in to the emerging stem cell application regenerative process. To learn more or see if you qualify, call the number listed below.

Mitchell B. Sheinkop, M.D.

847-390-7666

1565 N. LaSalle St., Chicago, Illinois, 60610

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Bone Marrow Concentrate for Arthritis; the potential benefits and risks

      

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.

847-390-7666

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.

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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Stem Cell Crier

Musculoskeletal Care of the Mature Patient

I’m back from a short Blog sabbatical, refreshed and with much to discuss. During the time away, I spent a week skiing in Colorado with my wife, read a book, The Immortal Life of Henrietta Lacks, a must read for anyone interested in or considering regenerative medical care, and kept up on issues that I believe would be of interest to readers. While I was gone, my staff continued to work and both finalized and submitted the request to The Institutional Review Board that will enable us to begin The Bone marrow Aspirate Concentrate Stem Cell (BMAC) management of osteoarthritis.  I will share with you what I read, watched and observed.

From the American Medical Association Morning Rounds of Tuesday, January 24, Leading the News “Stem cell treatment may help patients with macular degeneration”

On NBC’s The Doctors-Jan 25, a Regenexx stem cell procedure is featured for a patient with a failed microfracture in a woman with an arthritic knee seeking return to an active life style.

The Immortal Life of Henrietta Lacks , written by Rebecca Skloot is the fascinating biography of a woman whose cells were harvested without her knowledge in 1956 at Johns Hopkins; and ultimately became responsible for the world of regenerative medicine today. Along with the factual history of how the first cell cultures of human cells has evolved into the practice of medicine as we know it today, one learns about the evolution of medical ethics, government mandated patient protection and informed consent processes that govern contemporary medicine. You will better understand my approach to regenerative medicine when you finish this book named by more than 60 critics as one of the best books of 2010.

We arrived in Vail on Saturday afternoon, January 21, just as a snowstorm was starting. By time we ventured out on Sunday morning, there was 12 inches of fresh powder at the top of Rivas Ridge. It snowed again two more times during the week with another 14 inches of fresh powder by time we headed down Shangri-La in China Bowl. During the week, a friend came over from Breckenridge with his snow- board. By the end of our Wednesday skiing, I needed regenerative care for my entire body; almost no one was on the slopes besides us.

Over the next two weeks, I am scheduled to do site visits to observe and compare notes with centers involved in BMAC. If you want to move forward with learning whether you might be a candidate for regenerative medical care of your arthritis before scheduling that joint replacement, make an appointment or make a call. While no authority can promise success, there is an accumulating body of global information suggesting autogenous, autologous, adult bone marrow derived mesenchymal cells my be an effective, long term, anti-inflammatory and perhaps alter the natural history of degenerative arthritis.

Mitchell B. Sheinkop

1565 N. LaSalle Street

Chicago, Illinois 60610

847-390-7666

 

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FDA Warning on Stem Cells

Because of the 60 Minute Television program exposing fraud in the marketing of Stem Cells last Sunday, I feel it necessary to preempt the previously announced blog for this week with a word or more of caution.  Sometimes called the body’s “master cells,” stem cells are the precursor cells that develop into blood, brain, bones and all of your organs. When used as a medical treatment, there is the potential to repair, restore, replace and regenerate cells and thereby treat many medical conditions and diseases including arthritis.

But the Food and Drug Administration (FDA) is concerned that the hope, which patients have for cures not yet available, may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.  Witness the Sunday night episode of 60 Minutes.

FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

Regulation of Stem Cells

FDA regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use.

Stem Cells that come from bone marrow or blood are routinely used in transplant procedures to treat patients with cancer and other disorders of the blood and immune system.

Why my Pilot Study and then Clinical Trial? As part of these studies, I must show how the product will be harvested and prepared so that FDA can make certain appropriate steps are being taken to help assure the product’s safety, purity and potency.

Consumers need to be aware that at present—other than cord blood for certain specified indications—there are no approved stem cell products.

Advice for Consumers

  • If you are considering stem cell treatment in the U.S.,  ask your physician if the necessary FDA approval has been obtained or if  you will be part of an FDA-regulated clinical study. This also applies if  the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their  original location in the body. Cells in a different environment may  multiply, form tumors, or may leave the site you put them in and migrate  somewhere else.
  • If you are considering having stem cell treatment in  another country,  learn all you can about regulations covering the products  in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require  clinical studies designed to demonstrate that the product is safe and  effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little   information about foreign establishments or their stem cell products.  China has recently announced a governmental mandated regulation of a prior  free for all in the stem cell market.
  • To reemphasize my approach to realizing the promise of  stem cell management of arthritis; treatment at the Regenerative Pain  Center will only be offered via Pilot Study or Clinical Trial under FDA  governance and IRB regulation. Your cells will be harvested from your own bone marrow, concentrated, and administered to your arthritic joint.

Mitchell B. Sheinkop, M.D.

1565 N. LaSalle Street

Chicago, Illinois 60610

847-390-7666

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On Proteins, PRP, Bone Marrow Concentrate, Stem Cells and Orthokine

 

The difference between platelet-rich plasma therapy, also known as PRP, and the Orthokine treatment that Alex Rodriguez, Kobe Bryant and other athletes have received in recent months in Germany is fairly straight forward. I personally treat athletic injuries and arthritis with PRP; but, do not use the Orthokine procedure because it is not approved in the United States or Canada.

With PRP, I withdraw 20 cc blood, spin it in a special kit and inject plasma that is rich in platelets and lymphocytes into joints, thereby introducing growth factor and hopefully helping the body to heal itself. In the Orthokine procedure, 20 ccs of a patient’s blood are mixed in a tube with ‘factors,’ incubated for a time , the blood is spun down, and the substance is injected much in the same way as PRP.

The theory of Orthokine, which has also been used by Alex Rodriguez, Kobe Bryant and golfers Vijay Singh and Fred Couples, among other athletes, is that Orthokine addresses one of the possible triggers of joint disease; thought to be the protein interleukin. The theory is an attack on one of the culprits behind arthritis. The protein is an important part of the body’s immune system and has the ability to alter the function of other cells. IL-1 can be positive when it allows the body’s ‘repair troops’ to move in quickly to fight infection or other kinds of damage; but it can also trigger inflammatory processes that lead to degeneration and breakdown of cartilage.  These negative effects are primarily responsible for the pain and stiffness of osteoarthritis.

The Germans say that another protein that counteracts the effects of IL-1 is a ‘good protein’ in the body called anti-IL(1) produced by blood cells that protects cartilage by keeping the pro-inflammatory proteins in check. It is the body’s own natural anti-inflammatory and that is what gets mixed in prior to incubation.

In none of these treatments, PRP, stem-cell therapy Yankee pitcher Bartolo Colon had performed in the Dominican Republic. Is there good published research readily available that confirms they are effective, although it could turn out to be so. Individual anecdotes suggest they work. The procedures are not banned by the World Anti-Doping Agency or by Major League Baseball. However, Rodriguez was given the go-ahead by MLB and the Yankees to have it done in Germany. While PRP is available throughout the United States, the Regenerative Pain Clinic Bone Marrow Concentrate Stem Cell Pilot is now open for enrollment. Bone Marrow Concentrate has all the right proteins but does it work? Why am I advocating Bone Marrow Concentrate?

What’s in Bone Marrow Concentrate: Both pro- and anti-inflammatory cytokines and the factors: Fibroblast Growth Factor-b, PDGF-AB, TGF-B, and VEGF.

 Call to see if you might qualify for the clinical pilot trial.

Mitchell B. Sheinkop, M.D.

1565 N LaSalle Street

Chicago, Illinois 60622

847-390-7666

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