Significant degeneration of a joint surface typically leads to a total joint replacement. However, because of wear and loosening in active patients, surgery may not be a permanent solution. There is ample scientific evidence that Cell-based treatment has the ability to achieve superior structural regeneration when compared to a mechanical prosthesis.

 Regenerative medicine is an emerging field that seeks to repair or restore lost or damaged tissue function due to the effects of injury, disease, and aging.  I have declared an ongoing commitment to explore the potential of adult derived regenerative cells and identify those who have positioned themselves as global leaders in regenerative medicine.

Advances in understanding of the biology of adult stem cells have attracted the attention of the biomedical research and clinical community, including those studying osteoarthritis (OA). Autologous adult stem cells are immunologically compatible, can be harvested from a variety of sources, including bone marrow and adipose tissue, and have no ethical issues related to their use. Mesenchymal stem cells derived from bone marrow and adipose tissue are the most highly characterized and are considered comparable. Both have demonstrated broad multipotency with differentiation into a number of cell lineages, including adipose, osteo-, and chondrocytic lineages. However, the easy and repeatable access to subcutaneous adipose tissue, the relatively simple isolation procedure, and the approximately 500-fold greater numbers of fresh MSCs derived from equivalent amounts of fat versus bone marrow provide a clear advantage in using Adipose-Mesenchymal Stem Cells over Bone marrow-Mesenchymal Stem Cells.

 Adipose-derived regenerative cells                        Acronym:            ADRC 

 A population of cells derived from adipose tissue with stem cell and wound repair activities. Adipose-derived regenerative cells (ADRC) consist of several cell types, such as adult stem cells, vascular endothelial cells, and vascular smooth muscle cells, among others. These cells contribute to wound repair through a variety of mechanisms by promoting blood vessel growth and blocking programmed cell death (apoptosis). In addition, ADRC can differentiate into several tissue types, such as bone, cartilage, fat, skeletal muscle, smooth muscle and cardiac muscle.

 Isolation of cells from adipose tissue entails mincing and washing, followed by collagenase digestion and centrifugation. The pellet formed from centrifugation is deemed the Stromal Vascular Fraction (SVF), which is resuspended and used as the treatment modality. The SVF contains a heterogeneous mixture of cells including fibroblasts, pericytes, endothelial cells, circulating blood cells, and AD-MSCs. As I understand it and as a result of the cells’ “minimally manipulated” nature, many autologous stem cell therapies do not require an FDA drug approval application.

 While the knowledge of cellular and molecular mechanisms of Regenerative Stromal Vascular Fraction Cells has been increasing at an exponential rate, clinical progress in the management of arthritis has been minimal. An easily accessible byproduct of plastic surgery, the adipose stromal vascular fraction, contains elements directly capable of promoting regenerative potential and decrease ongoing inflammation.

 While there are ongoing clinical efforts to heal small geographic cartilaginous defects using stem cells as an adjunct in the United States, to the best of my knowledge, treatment of arthritis with Adipose-derived regenerative mesenchymal cells alone to heal lesions in cartilage or alter the natural history of degenerative arthritis in the hip, knee and shoulder is not available. One would have to travel elsewhere at a substantial cost for said treatment.

The stats helper monkeys at WordPress.com mulled over how this blog did in 2010, and here’s a high level summary of its overall blog health:

The Blog-Health-o-Meter™ reads This blog is doing awesome!.

Crunchy numbers

A Boeing 747-400 passenger jet can hold 416 passengers. This blog was viewed about 5,000 times in 2010. That’s about 12 full 747s.

In 2010, there were 40 new posts, growing the total archive of this blog to 72 posts. There were 70 pictures uploaded, taking up a total of 3mb. That’s about 1 pictures per week.

The busiest day of the year was November 2nd with 128 views. The most popular post that day was Another Prosthetic Recall.

Where did they come from?

The top referring sites in 2010 were drsheinkop.com, mail.yahoo.com, surfacehippy.info, healthfitnesstherapy.com, and mail.live.com.

Some visitors came searching, mostly for hip prosthesis recall, prosthetic hip recall, sheinkop, knee replacement blog, and dr. mitchell sheinkop.

Attractions in 2010

These are the posts and pages that got the most views in 2010.

Another Prosthetic Recall August 2010

The Cutting Edge? September 2010

About April 2010

Off-label use of orthopedic drugs and devices September 2010

Sex after a total joint replacement June 2010

 Musculoskeletal Care of the Mature Patient

 FROM THE INTERNATIONAL CELLULAR MEDICINE WORKSHOP

Warning: stem cells are not FDA approved for use in orthopedic surgery unless the application is in conjunction with a surgical procedure. Strictly forbidden are staged expansion and any form of “pushing”. Be aware that experimentation is not necessarily research.

When might stem cells be indicated in orthopedics?

Stem cells from Platelet Rich Plasma

Stem Cells from Adipose Tissue

Stem cells from Bone marrow

Stem cells from Aphaeresis (hematopoietic stem cells)

 At this time, there is a paucity of published, statistically based evidence to support the use of stem cells in lieu of established safe and successful treatment modalities. The claims for clinical success are anecdotal or published in foreign medical literature. At the same time patients are going offshore and abroad for stem cell management of ligaments, tendons, bone and cartilage. The process involves autologous, adult cell harvesting, separation, activation, and return. If the aforementioned can be accomplished within 45 minutes and as an adjunct to a surgical procedure, I believe the use of autologous stem cells is approved in the United States. While in the described setting, adipose tissue would produce the largest number of stem cells and present machinery would make the application come closer to meeting FDA requirements, the manner of “pushing” is still a concern. Bone marrow by producing less stem cells and thus necessitating a subsequent procedure has little application in the US under FDA standards as now written. Platelet rich plasma may provide some growth factors but a paucity of cells. 

 Fracture healing

Several clinical researchers have been able to use stem cells to heal non-unions. Autologous Mesenchymal Stem Cells have been used to heal segmental defects (> 4 cm) in limited numbers of patients.

 Intervertebral disk

When autologous MSCs were transplanted into an animal research model of degenerative disk disease, the treated achieved 91 percent of the height of their disks 24 weeks after transplantation; the control group achieved only 67 percent of disk height

Sports medicine

Injuries related to disruption of ligaments or tendons are common and healing of these disrupted tissues results in an inferior-quality tissue. Cell-based therapy is actively being investigated as a new method of treating these injuries.

 MSCs have been studied in the repair of meniscal injuries. Tears in the inner third of the avascular region of the meniscus have a limited capability to heal. New studies are beginning to examine whether these same techniques can be used to improve the results of human meniscal repair.

 Arthritis

The hope is that stem cells placed near a damaged joint surface will stimulate hyaline cartilage growth.

 Tissue engineering procedures are still at an experimental stage. Most tissue engineering is performed at research centers in the United States as part of clinical trials.

 Offshore operations: a dangerous scam or are we behind the curve?

 Musculoskeletal Care of the Mature Patient

 FROM THE INTERNATIONAL CELLULAR MEDICINE WORKSHOP

Warning: stem cells are not FDA approved for use in orthopedic surgery unless the application is in conjunction with a surgical procedure. Strictly forbidden are staged expansion and any form of “pushing”. Be aware that experimentation is not necessarily research.

What are stem cells?

Stem cells help to create new cells in existing healthy tissues, and may help repair tissues in areas that are injured or damaged. They are the basis for the specific cell types that make up each organ in the body. 

Stem cells are distinguished from other cells by a few important characteristics: they have the ability to self-renew; they have the ability to divide for a long period of time; and, under certain conditions, they can be induced to differentiate into specialized cells with distinct functions (phenotypes) including, but not limited to, cardiac cells, liver cells, fat cells, bone cells, cartilage cells, nerve cells, and connective tissue cells. The ability of cells to differentiate into a variety of other cells is termed multipotency.

 The delivery of stem cells may have a therapeutic benefit by accelerating the repair of injured tissue or by slowing the degenerative process that occurs in OA. The goal is biologic repair rather than a prosthetic implant.

While it is true that stem cells are multipotent, in order to make them functional, there has to be harvesting, then separation from other cell lines, next comes specific organ or tissue activation followed by return to the patient. 

Stem cells in Platelet Rich Plasma

It is the nucleated cell portion where the stem cells live. While platelets have growth factors, mesenchymal stem cells from centrifuged platelets with immediate reinfusion are too few in number and underperform

Stem Cells from Adipose Tissue

Adult mesenchymal stem cells are exceedingly numerous here, so much so that they need not be expanded but they still need to be pushed (activated) in order to differentiate into stromal tissue and secrete growth factors while promoting angiogenesis. 

Stem cells from Bone marrow

The bone marrow needs to be recovered by needle aspiration, concentrated, expanded and pushed before reinfusion to a joint at some later time. It is a two step process and apparently adversely affected by many commonly used pharmaceuticals. 

 Stem cells from Aphoresis (hematopoietic stem cells)

Whole blood is collected from a vein and placed in a centrifuge. The mononuclear cells where the stem cells reside are filtered out. Everything else is returned to the patient. It takes four hours for the collection of whole blood and that whole blood is re-administered at about the same time. It is a process preceded by agents that mobilize bone marrow and infusion or freezing of the stem cell must take place in 48hours

 To be continued

Musculoskeletal Care of the Mature Patient 

The Basic Science of Aging :Implications for the Male and Female Master Athletes In March, I introduced the continuum of blogs focusing on the Musculoskeletal Care of the Mature Athlete. In my introductory blog, I stated that I would analyze with my reader multiple subjects including cartilage generation techniques.

In keeping with that commitment, I will be attending the 2nd Annual International Congress on Regenerative and Cell Based Medicine, to be held on November 11-12, 2010 in Las Vegas, Nevada. Sponsored by the International Cellular Medicine Society (ICMS), a global nonprofit organization dedicated to physician education and patient safety, and co-hosted by the Age Management Medicine Group (AMMG), this unique conference is focusing on the latest developments in cell based medicine featuring expert speakers who are driving research and using these technologies as part of their everyday practice of medicine. The event will showcase presentations made by internationally acclaimed physicians on the use of platelet rich plasma; adipose tissue, bone marrow, and peripheral blood derived stem cells; as well as data on the application of these promising therapies in providing orthopedic treatment to patients today. Guided by experts, I will have the opportunity to update my knowledge in the field, and receive valuable take-home information that will allow me to optimize my patient care and treatment efficacy.

This year, in conjunction with the International Congress, the ICMS will also hold a one day training course: Essential Knowledge in the Collection of Stem Cells. This workshop will bring together global experts to aid me in understanding the basic skills—from patient candidacy to the collection of stem cells from bone marrow, peripheral blood, and adipose tissue—required of cell based medical techniques. It is my ultimate goal to provide you with the information needed to optimize patient safety and to educate you on current cell based technologies and evolutions. My mission is to offer my patients treatment modalities that are current, approved and safe. The evolving discipline of cellular medicine is so promising that there is at present, hesitation of orthopedic industry investment in creating a new generation of prosthetic implants for our hips and knees. Is a biologic arthroplasty on the horizon? The stem cell is the promise for the future treatment of arthritis. My mission is to determine when is the right time to add these options to my treatment alternatives and I will let you know my plans next week.

Musculoskeletal Care of the Mature Patient

 What’s the best hip or knee prosthesis? More importantly, do you really need surgery? What about the type or length of that surgical incision? Is a 23-hour hospital stay for a joint replacement the best option?

While I have been personally involved in data collection and clinical studies for over 35 years, it wasn’t until April of 2009, that a sincere global initiative was introduced within the American joint replacement community to create a United States total joint registry.

Scientific outcomes, patient satisfaction, and prosthetic performance studies leading to publications after total hip and total knee replacement continually provides me with information concerning what works and what doesn’t work. The problem is an inherent potential bias in the reporting process. That bias is eliminated with a joint replacement registry. Recently, other criteria for prosthetic performance have been established by way of Product Recall announcements from the several orthopedic manufacturers. The latter is a retrospective announcement when a prosthesis fails to perform after FDA approval and the company is sent a warning letter by the government agency. Until 2008, orthopedic companies have been preempted from legal redress for product liability but that protection has taken away by the Congress.

The reasons for considering hip or replacement surgery are to relieve pain, restore motion, correct deformity, and improve the quality of life. Whether at age 45 or 85, published studies have documented patients with arthritis of the hip and knee, who have undergone joint replacement surgery, in over 95% of those studied recorded a very high degree of immediate as well as long term satisfaction with the results of surgery.    Published long term satisfaction rates have allegedly remained not too different; but recent product recalls and s sudden spike in the occurrence of revision surgery maybe reason for re-evaluation of our thinking.

Is this tendency toward increased revision numbers the result of less bone resection and minimally invasive surgery with the promise of rapid recovery. Shorter hospitalization and less pain? Is the increase in revision surgery because of our introduction of new technologies that aren’t living up to the manufacturers’ promise? From the patient’s standpoint, be discerning about where you get your decision making input.

A second opinion is worth the time and effort before deciding on the need for surgery, the surgeon and the type of implant.

 Musculoskeletal Care of the Mature Patient

Is there an approach to treatment of symptomatic osteoarthritis of the knee for patients who aren’t ready for a knee replacement and who would prefer postponement by several years? What is to be done for the patient with altered quality of life who has been cautioned against joint replacement surgery because of systemic illness such as heart disease?

 The combination of pulsed electrical stimulation with a brace to reduce the load on the affected compartment may be the answer to reducing pain and increasing a patient’s function. The concept of pulsed electrical stimulation for treating symptomatic patients experiencing debilitation form osteoarthritis is not new, the FDA has cleared the device as an adjunctive therapy for osteoarthritis of the knee based on clinical studies in 2006 and 2007. The efficacy of an unloading knee brace has also been examined in depth. That information has been available since 1999 as an addition to standard medical treatment for osteoarthritis of the knee.

Enter the combination of an unloading brace coupled with a pulsed electrical system and there is the potential to postpone knee replacement surgery for years and to manage arthritic patients wherein a co-morbidity, systemic illness, will not allow a patient to safely undergo a knee replacement. Will it work? To answer the question a multicenter clinical study has been developed and I have been recruited to serve as one of the centers for the FDA study. Medicare is sufficiently enthusiastic about the potential success of this form of management for osteoarthritis of the knee that it will pay for the device.

Should you decide to avail yourself of this method of management for an osteoarthritic knee because you are not ready for surgery or because you have been advised that surgery carries too great a risk, after a physical examination and review of your X-ray, should you meet the study criteria, you will be measured for the device. Full informed consent will be executed at the time of the office intake. The participant’s burden is to wear the unit eight hours a day for four months. The eight hours of mandatory usage need not be continuous. Follow-up visits are not burdensome but will be required over the ensuing five years.

Part two

 Why the Caymans for a hip or knee replacement? Several years ago, I was invited to the Grand Cayman Island to evaluate its potential as a destination for medical tourism. Patients who could not enjoy the option at the time for hip resurfacing in the United States were traveling to India because of a delay in FDA approval. For those unfamiliar, hip resurfacing is an alternative to hip replacement and of great interest to a younger, active patient population. The promise is a more functional outcome when compared to that of a standard hip prosthesis. Medical tourism also was and still is of interest to the uninsured and the payer because of cost savings when health care is delivered outside of the United States. The question remains about the safety and outcomes of health care delivered without all of the safeguards we take for granted in the United States? Aware or the concerns about safety and access and with my experience in teaching orthopedic surgery around the world, I decided to investigate the potential of the Caymans as a destination close to the U.S., in a country that is a continuum of the British Commonwealth with all of the enticement of the Caribbean. English is the primary language, crime is at a minimum, the majority of physicians have been trained in the United States or Canada and the people are friendly.

What I have discovered is the potential for an optimum environment in which to access orthopedic surgery. Up until now, the expatriates who live in the Caymans have returned home for joint replacement and the Caymanians themselves have traveled to Florida for care. With further investigation, I learned that the principal reason for the medical tourism away from the Island was the lack of surgical subspecialty expertise. Three months ago, I found a contemporary design-imaging center with all of the services needed to provide clinical support to a surgical subspecialist. I learned of the growing number of fellowship trained, Board Certified surgeons and related medical services developing under the umbrella of Harmonic Health Consultants including hip and knee replacement. I have helped develop an intense and personally supervised rehabilitation/recovery program revolving around an integration of the physical, mental and minimum pain components. It makes sense to take a time out from your daily life and travel to the Caymans for your hip or knee replacement and dedicate a full week or two to recovery for the best possible outcome.

         To learn more about orthopedic surgery in the Caymans, contact

    The Harmonic Health Group :       info@harmonichealthgroup.com