Dec 13, 2018
You may recall from my last several Blogs that The American Journal of Orthopedics published my paper in November: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis. While surfing the internet this morning, I noted that many physicians are labeling the procedure a source of stem cells; it is not.
Lipogems is now U.S. Food and Drug Administration (FDA) approved for use in Orthopedics. The proprietary name is applied to a Micro-fragmented Adipose Tissue Transplant System that was the technology I introduced and monitored in a scientific clinical trial dating back three years leading to the publication. Federal regulators have now cleared the way for the device and technology that uses a patient’s own body fat (known clinically as adipose tissue) to assist in the healing process. Lipogems is attractive to orthopedic physicians because it is compliant with the latest FDA guidelines and is cleared for use in orthopedics. Unfortunately, clinics and physicians are erroneously, describing the procedure as a source of stem cells; I will emphasize again it is not. Even the Lipogems company uses term reparative and not regenerative.
The Power of Fat
When I grew up, my grandmother and mother fed me chicken soup for whatever ailed me. Many patients are looking for another option to major invasive surgery. Fat has many important cells and is easy to get from the patient’s body. Micro fragmented adipose tissue may be an option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.
In November 2017, the FDA finalized its rules guiding the use of Human Cellular and Tissue Products. The Agency reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue, and that it is intended for homologous use. “Fat has been used for many years in support of the repair or replacement of damaged or injured tissue,” according to Dr. Arnold Caplan of Case Western Reserve University in Cleveland, Ohio. “Fat has a high concentration of reparative cells and is a very powerful tissue. How the fat is processed makes a huge difference on the quality of the tissue and if it meets the new FDA guidelines.”
To schedule an evidence-based consultation for your arthritic joint, call (312) 475-1893.
You may access my website at www.sheinkopmd.com
If you schedule before the end of the year, I will share my wife’s chicken soup recipe on request
Tags: arthritis, athletes, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, FDA, Interventional Orthopedics, knee pain, lipogems, Micro-fragmented Adipose Tissue Transplant, Osteoarthritis, stem cells
Dec 5, 2018
As interest in biologic therapies for arthritis-a needle, not a knife-continues to expand; patients increasingly are turning to the ads in newspapers or searching the Internet to gather information on this topic. While there is still a lack of scientific consensus on the use of biologics, it is most important for those seeking information not to be misled. My own analysis of resources for patients seeking on line information about biologic therapies for arthritis is that the overall quality is very poor and anything but scientific. Even worse, is a seminar, neither a reliable or credible source of scientific evidence.
Biologic therapies consist of stem cells, platelet rich plasma product and bone marrow aspirate concentrate. New research, I co-authored and that was published last month in The American Journal of Orthopedics: Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Arthritis, is indicative of the ever-evolving nature of Regenerative Medicine. Biologic therapies and their use in arthritis or musculoskeletal injury in general are an area of vast research and interest within the medical field. Understanding the information online and the misinformation provided at seminars pertaining to biologics allows me to tailor my conversation and address commonly found inaccuracies.
The use of Biologic Therapies is expected to significantly increase in the coming years as our knowledge advances on the use of such. That initiative will be led by well informed, well-educated Board Certified, and Fellowship trained specialists. Unfortunately owing to the relative lack of oversite at present, every type of charlatan, parasite and camp follower can buy an ad for a seminar or produce a web site on the internet. How then should a patient with pain and limited function from arthritis seek to postpone or avoid surgery without becoming a victim of the cord blood or amniotic fluid hoax?
- Your physician must complete a comprehensive medical history, physical examination and review of diagnostic studies.
- Explain the disease process and grade of progression,
- Discuss possible treatment options,
- Present a balanced assessment of the current scientific evidence.
Woe, while writing this Blog, I was just notified about acceptance of yet another scientific article by a peer reviewed medical journal in which I am the senior author: A Specific Protocol of Autologous Bone Marrow Concentrate and Platelet Products Versus Exercise Therapy for Symptomatic Knee Osteoarthritis; a Randomized Control Trial with 2 Year Follow-up.
Hopefully some time soon, a Biologic Arthroplasty will be possible; but until then, a Total Joint Replacement is still a necessary option for those not meeting specified inclusion criteria for biologics. To see what treatments may be possible for your arthritic generated pain call (312) 475-1893 to schedule a consultation. Visit my website www.SheinkopMD.com for additional information.
Tags: Adult Mesenchymal Stem Cells, amniotic fluid, ankle pain, arthritic pain, autologous bone marrow concentrate, biologic, biologics, cellular orthopedics, Cord blood, Hip pain, injury, joint pain, knee pain, lipogems, Osteoarthritis, PRP, regenerative medicine, rupture, shoulder pain, sports injury, stem cell, tear, tendinitis
Nov 29, 2018
My Blog has frequently addressed the false ads claiming Amniotic Fluid, Chord Blood, Wharton’s Jelly and the like contain living stem cells emphasizing that the processes of preservation and sterilization followed by freezing kills off any living cells. Sylvia Perez first addressed the issue on Fox News’ Conversation in Health, January 29, 2018 and Pam Zekman posted her investigative report on WBBM-TV, the week before Thanksgiving. Yet patients continue falling for the hoax.
In contrast, let’s address the positive, cellular orthopedics; the ongoing practice of evidence- based medicine. Below are two statistically significant scientific studies that play a role in helping determine the best possible outcomes to a regenerative intervention
November 21, 2018
Safety and Efficacy of Micro-Fractured Adipose Tissue for Knee Osteoarthritis
New research published by TOBI Faculty suggests autologous, micro-fractured, minimally manipulated adipose tissue may represent a nonsurgical treatment option for knee osteoarthritis patients seeking alternatives to total knee replacement.
Congratulations Jay Panchal, MD, Gerard Malanga, MD, Mitchell Sheinkop, MD on this new publication in The American Journal of Orthopedics.
Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees
To download or read the publication: https://www.amjorthopedics.com/article/safety-and-efficacy-percutaneous-injection-lipogems-micro-fractured-adipose-tissue
Treatment of Knee Osteoarthritis with Autologous Bone Marrow Concentrate and Cytokine Concentrate – A Prospective Clinical Case Series Study
Abstract submitted to the Orthopedic Research Society Annual Meeting, 2019
Mitchell B. Sheinkop1 , Marry Langhenry2 , Jizong Gao3 1. Orthopedic Surgery, Rush University, Chicago, IL.2. Cellular Orthopedics, Chicago, IL 3. Celling Biosciences, Austin, Texas.
INTRODUCTION: Osteoarthritis (OA) is an organ disease that affects most structures of the joints including cartilage, synovium and subchondral bone. The pathophysiology of knee osteoarthritis can be broken down into pathoanatomy, cell biology, and genetics. Although fibrillation of articular cartilage is regarded as the primary changes and potential cause of clinical symptoms, the synovium and capsule undergo progressively inflammatory changes and secrete proteolytic enzymes that may contribute to the progression of OA. Meanwhile, the subchondral bone tissue develops lytic lesions with edema, sclerosis, and cyst formation. Therefore, it has been recommended that the treatment of OA should be a comprehensive approach to create a homeostatic environment to facilitate the OA treatment with a long-lasting outcome. Bone marrow contains mesenchymal stem cells (MSCs). Different cytokines such as alpha 2-macroglobulin (A2M) (Wang et al) and growth factors have been identified in the blood and bone marrow aspirate. Either bone marrow concentrate (BMC) or MSCs have been injected into the knee joint to treat OA with promising clinical outcomes. Hernigou et al reported that injection of BMC into the subchondral bone area was able to delay or eliminate the need for total knee arthroplasty (TKA) and clinical outcome was comparable to TKA in the contralateral knee. Cytokines and growth factors in the blood or bone marrow aspirate were concentrated by filtering method to prepare autologous therapeutic biologics. In the current study, a consecutive series of patients with moderate to severe OA were treated by intra-articular and intra-subchondral bone injection of BMC and autologous concentrated cytokines/growth factors. The quantity of representative cytokines and growth factors in the concentrate were also measured. Patients were evaluated for the improvement of systems and knee functions by following up to 6 months after injection. METHODS: This prospective case series study was approved by the Institutional Review Board.
To learn more or to schedule an evidence-based consultation call (312) 475-1893
You may visit my web site and read my blogs at www.sheinkopmd.com
Regenerative Medicine is an option for those with arthritis but don’t be fleeced by the hucksters and camp followers.
Tags: autologous bone marrow concentrate, biologics, BMC, cellular orthopedics, cytokine concentrate, Growth Factors, knee pain, lipogems, Micro-Fractured Adipose, MSC, OA, Orthopedic Surgeon, Osteoarthritis, PRP, regenerative medicine, stem cells, suchondral, TOBI
Sep 27, 2018
Until 2002, the patient seeking a joint replacement consultation would ask me “how long will new joint last”? Then came the era of minimally invasive surgery -I played a major role in the introduction-and now the question became “how long is the incision?” and “how long will I stay in the hospital?” While the number of “Regenerative Medicine” options for the treatment of osteoarthritis continues to increase, in the current medical marketplace, it is via direct to consumer advertising that “breakthroughs” are brought to the attention of those impacted by the symptoms and limitations of Degenerative Joint Disease. Whereas patients historically would base their personal medial decision making on consultation and guidance from the medical community, such is no longer the case. Media marketing is now the primary reason a patient makes the decision for which Regenerative option to choose. The problem is there is little if any scientific evidence to support the ad claims. In the one or two approaches where there is a paucity of evidence, the latter is on a handful of subjects at less than six months. Witness the recent reversal on insurance reimbursement for several placental derived products because of the absence of benefit at six months in clinical trials.
Included among the reasons featured in ads promoting Stem cells for arthritis, you will find,” it worked for me”. More recently it is a product that “recruits” your Stem Cells. On it goes with promotions for Stem Cells in cord blood, Stem Cells in Wharton’s Jelly, and Stem cells derived from your adipose tissue (fat). Missing from the entire marketing campaign in almost every scenario is outcomes data. I am an orthopedic surgeon who, prior to my Cellular Orthopedic initiative, played a major role in joint replacement surgery as Professor of Orthopedics and head of a prominent joint replacement program at a large Medical Center in Chicago. While performing clinical trials with new generations of hip and knee implants, it was well accepted in the orthopedic community that a minimum of two year follow up would be required before a scientific paper would be considered for publication. When I entered the emerging specialty of Cellular Orthopedics, I continued the integration of clinical practice with clinical research so that my interventional recommendations would be evidence based. Below are two of the manuscripts I co-authored; one having been accepted for publication and the other recently submitted for publication.
Safety and Efficacy of Percutaneous Injection of Lipogems Micro fragmented Adipose Tissue for Severe Osteoarthritic Knees
A Specific Protocol of Autologous Bone Marrow Concentrate and Platelet Products Versus Exercise Therapy for Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial with 2 Year Follow-Up
What I won’t promote is anything wherein there is not two years minimum of evidence concerning safety, efficacy and satisfactory clinical outcomes. I am not opposed to progress but best practices demand clinical trials of new options and those trials should be underwritten by the pharmaceutical company; not by a patient paying relatively large sums without meeting inclusion criteria and without follow-up leading to minimum two-year outcomes evidence.
To learn more, schedule an appointment (312) 475-1893. You may visit my website www.Sheinkopmd.com
Tags: adipose tissue, Bone Marrow Concentrate, cellular orthopedic, lipogems, OA, PRP, stem cells
Feb 16, 2018
I am sitting at my computer this morning writing the weekly Blog posting and not attending the IOF meeting taking place today in Broomfield, Colorado; yet I am reporting about the meeting. Instead of attending, I am preparing for a week-long ski adventure with my family next week in Vail, Colorado while trying to catch up in my practice. How is it than possible that I know what is taking place at the meeting? Listed below are five of the 10 ongoing or completed cellular orthopedic clinical trials in which I am a principal investigator or co-researcher. The preliminary and final data resulting from these clinical research initiatives is the outcomes foundation for what is being presented at the IOF podium today and tomorrow.
1) Stem Cell Counts and the Outcome of Bone Marrow Concentrate intra-articular and intra-osseous (subchondroplasty) interventions at the knee for grades 2 and 3 OA. (supported in part by Celling). Ongoing
2) Outcomes of Bone Marrow Concentrate (stem cell, platelet and growth factor) Intervention at the Knee for Grades 2 and 3 OA in 50 patients at 2 to 4 years. (supported in part by Regenexx)
3) Outcomes of Intra-articular Bone Marrow Concentrate versus those of combined Intraarticular and Intraosseous interventions for grades 2 and 3 OA at the knee at one year. (self-funded). Ongoing
4) How does the PRP and Mononucleated cell count affect the outcome of a BMC intervention for grades 2 and 3 Knee OA? (a joint project with Greyledge) Ongoing
5) Safety and Efficacy of Percutaneous Injection of Micro-Fractured Adipose Tissue for grade 4 Osteoarthritic Knees, minimum follow-up of 18 months in 30 patients (supported in part by Lipogems)
I had to prioritize; and since most of the arthritis data being presented is all or in part mine, I already know the subject matter. By staying home, I also found the opportunity to browse “stem cell” websites as suggested by ads in today’s newspapers or introduced by email blasts this week. Wow, a patient acting more like a consumer is really at risk for succumbing to Regenerative Medicine “false news”.
If you want to learn more about the difference between the stem cell purveyors and a legitimate, FDA compliant, evidence based, cellular orthopedics initiative, call to schedule a consultation or to get a second opinion.
You may schedule a visit at (312) 475-1893
You may access my website and watch a webinar at www.ilcellulartherapy.com
Tags: arthritis, bone marrow, Celling, cellular orthopedics, Growth Factors, Hip pain, International Orthopedics Foundation, joint pain, knee arthritis, knee intervention, knee pain, lipogems, Micro-Fractured Adipose, Osteoarthritis, PRP, regenerative medicine, Regenexx, stem cells, Subchondroplasty
