The other day, I noted a www.Ilcellulartherapy.com (my web site) request from a patient seeking to schedule an appointment at my office. That phone call had been placed ten days earlier and my assistants failed to respond in a timely manner. When eventually returned, the potential patient indicated that she had decided to seek consultation elsewhere. I can understand her frustration and yet would her orthopedic needs have been better served by placing a second request? I share this with you and admit we are human; as hard as we try in achieving 100% patient satisfaction, at times the system doesn’t operate as intended. The ultimate question is where to seek Cellular Orthopedic consultation and treatment even if initially, the response is not as either side would like?
For almost five years of a Cellular Orthopedic, Regenerative Medicine practice, I have integrated patient care with clinical research. This is my contribution to the evolving discipline of Stem Cell therapy for arthritis; and is based on what I introduced into orthopedic surgery during my 37-year academic joint replacement career. It is only by monitoring outcomes that we continue to learn and improve results.
Listed below are my clinical research endeavors over the past five years and the basis for my clinical recommendations:
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)
6) A Lyophilized Amniotic Fluid Clinical Trial for Grades 2 and 3 Knee OA (supported by MiMedx) Ongoing
7) An Amniotic Fluid Cryopreserved Clinical Trial for Grades 2 and 3 Knee OA in 30 patients. (supported by MiMedx)
8) An Amniotic Fluid Cryopreserved Clinical Trial for Grades 2 and 3 Knee OA in 45 patients. (sponsored by Liventa)
We Have The Evidences for Cellular Orthopedics; ask the camp followers to show you theirs.
To schedule an office visit call 312 475 1893 and please be patient.
Tags: cellular orthopedics, Clinical Trial. Mitchell B. Sheinkop, regenerative medicine, stem cell treatment, stem cells, Subchondroplasty
“____ and I are doing well. Mitch administered stem cell therapy on my non-operative hip and things feel great. First time I’ve been pain free in 10 years. Can’t wait for ski season” “Mine are doing great”. This second quote from the mutual friend who is patient getting ready for the ski season who recently underwent a concentrated platelet rich plasma “tune up” in anticipation.
The above quotes are from a husband and wife who underwent stem cell intervention and the second is taken from an e-mail forwarded from the mutual friend who had initially referred the couple to me. Three years ago, the wife had been referred for the limitations in her knee produced by post traumatic arthritic progression. She and her husband were avid ski enthusiasts but the patient could not plan for an upcoming helicopter skiing that winter in western Canada, owing to limitations imposed by arthritis. In the fall of the year, I completed a Bone Marrow Concentrate intervention into her right knee and she returned to Heliskiing. Earlier this summer, the husband elected to undergo a right hip intervention so he might continue at the highest level of recreational skiing. According to his report, there is patient satisfaction from both sides.
Yet, I still strive to improve outcomes and patient satisfaction with the duration of effect. In order to improve results, benefit, and extend the success, I introduced the intraosseous alternative into my treatment protocol when deemed indicated. If the preoperative imaging is compatible with the potential to improve the end result by a subchondroplasty, as I did for a patient this past Wednesday, not only will Bone Marrow Concentrate be injected into the joint, a biologic implant will be injected into the bone adjacent to the joint. The additional procedure adds nothing to the cost of care nor does it require any alteration in the postoperative rehabilitation process. I have requested precertification to determine if indemnification will cover the intraosseous injection of the biologic implant.
On a scientific basis is the fact that it is the subchondral bone that supports the cartilage lining the joint surface. If there is an insufficiency or fragility of subchondral bone, the cartilage will eventually fail. It has been suggested that the pain of arthritis may be the result of alterations in the subchondral bone in addition to inflammation within the joint. Please remember that there are no nerves in cartilage.
To determine if you are a candidate for postponing or avoiding a Joint replacement for the pain and limited function attributable to arthritis and what treatment alternative will result in the most satisfactory and longest lasting end result, call for a consultation
Call (312)475 -893 or visit my web site and watch the webinar: www.ilcellulartherapy.com
Tags: arthritis, Bone Marrow Concentrate, cellular orthopedics, Concentrated Stem Cell Plasma, Interventional Orthopedics, stem cell treatment, stem cells, Subchondroplasty
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
Out is routine Medicare and insurance coverage indemnification of hyaluronic acid injections for osteoarthritic joints other than the knee. Additionally, several insurance carriers are now requiring pre-certification to determine if they will even cover hyaluronic acid injections of the knee. The phenomenon was first reported in Florida but now the reduction in coverage is spreading across the country including Illinois. A physician may decide to proceed with the single, thee part or at times five part injection series but it would be at the expense of the patient if insurance and Medicare deny coverage. The reason behind the decision has to do with long-term studies that fail to validate the claims of the many advertisements you may see on television or find in the newspaper concerning the various forms of hyaluronic acid as a gel.
Increasingly in is Amniotic Fluid Concentrate for Osteoarthritis even though not covered by Medicare or Insurance. The clinical trial regarding outcomes for said therapy are incomplete; and to the best of my knowledge, the only source of Amniotic Fluid Concentrate providers seriously investigating results is MiMedx, out of Marietta, Georgia. Nevertheless, there seems to be an ever-increasing presence of Amniotic Fluid Concentrate offerings in the medical marketplace; unfortunately with unsupported claims of a stem cell content. There does seem to be a benefit from amniotic fluid concentrate in relieving the symptoms of an osteoarthritic joint but we have to wait for completion of current clinical trials to understand proper dosage and the length of action.
If you are a regular reader of this Blog, you will have become familiar with the term Subchondroplasty, an adjunct that I have been offering on occasion in conjunction with Bone Marrow Concentrate/Stem cell procedures into the joint. The successes of Subchondroplasty are such that the attention to the bone supporting the joint when working inside the joint is a subject gaining increased attention on a national basis. It looks like the future will be an increasing combination of both intra-articular and extra-articular intervention. While no one is able to confirm why the decompression of the bone adjacent to a joint relieves pain and why the adjunct of biologics improves longer-term outcomes, attention to bone defects in the area around the joint is proving to make a major difference in outcomes for arthritis. The question now is whether the best approach is Bone Marrow Concentrate inside and outside the joint or Bone Marrow Concentrate inside the joint with a synthetic augment outside the joint?
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx-SD, stem cells, Subchondroplasty, 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