Non-Surgical Regeneration of Joints
Before Joint Regeneration the last major innovation in the specialty of Orthopedic Medicine was the arthroscope. This innovation allowed surgeons to use less invasive procedures to address diseases and injuries of the joint. As a result, joint replacements declined and ligamentous and other soft tissue injuries within and around the joints were more efficiently treated. In recent years the medical community has begun to realize the benefits of biologics for of orthopedic conditions. Arthritic joints that are currently managed by short term medication relief or surgical treatments may be more effectively and economically addressed with markedly less invasive procedures.
At Advanced Joint Replacement Center of Southern Oregon, through our regenerative medicine division, our ultimate goal is to reduce pain and help as many arthritic patients as possible to achieve substantially improved functionality and quality of life. For patients where surgical intervention may not be the best option, we offer therapies using human cell and tissue products (HCT/P). These therapies work by harnessing the body’s ability to heal itself. This is not new science as it has been investigated and applied to practices internationally for over 15 years.
What is Regenerative Medicine?
Regenerative Medicine is a branch of translational research in tissue engineering and molecular biology which deals with the “process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function” (www.wikipedia.org/wiki/Regenerative_medicine). Regenerative medicine therapies arose to explore new therapeutic treatments. Reports of people with horribly debilitating disorders improving after receiving these therapies are being reported almost daily on the local news channels. Regenerative medicine therapy using HCT/Ps has the potential to replace damaged tissues and restore function. These therapies an additional option for people whose joint pain is intractable.
Regenerative medicine therapies using both biologics and HCT/Ps involves delivering specific cells to the exact location to ultimately restore tissue and function. The specific injections given are full of mesenchymal stem cells (MSCs) and other important growth factors to promote regeneration and healing. Multiple research and clinical trials have endorsed the use of stem cell therapy as a safe and effective way of treating arthritis and other joint disorders.
What is a Mesenchymal Stem Cell?
The general perception is that therapies using stem cells must involve some “super science” and is financially unattainable. The fact is, it does involve “super science” but that doesn’t mean it can’t be explained simply. Basically, a stem cell is different from other cells for two important reasons. First, it is an unspecialized cell that is capable of renewing itself. It is a cell waiting to become something. Second, it is a cell that can be induced to become a variety of different cells. This is a property called pluripotent or multipotent. Pluripotent being able to become any tissue and multipotent being able to become most tissue. This serves as an internal repair system. However, as we age so do our stem cells. The consequence is a decreased ability to do the repair that we demand. Therefore, the cartilage in our joints lose their compressive resistance and start to fissure and fail. The exciting news is that we can now add stem cells back into the system which will stimulate new growth.
How Does a Stem Cell Work?
As mentioned earlier, a stem cell, specifically mesenchymal stem cells, are pluripotent (able to turn into all other cells). When stem cells divide, they can become another type of tissue or stay stem cells. Stem cells basically work in two ways. The first is by replacing the damaged cell by engrafting and differentiating into the required cell type. The second way is through a process called the Paracrine Effect. In this process the donor cells secrete factors that signal the host cell to repair without being physically in touch. Many pre-clinical studies have observed damaged tissue being repaired after stem cell transplant with a noticeable absence of donor cells. This paracrine effect is observed to have a long term effect on tissue regeneration.
The Sources of Stem Cells
Embryonic – Embryonic stem cells are obtained from the inner cell mass of the blastocyst, a mainly hollow ball of cells that, in the human, forms three to five days after an egg cell is fertilized by a sperm. Human embryonic stem cells are generated mainly from blastocysts that are the result of in vitro (the lab) fertilization for assisted reproduction, but are not needed for implantation into the mother. In some countries, such as Britain and the United States, the parents can donate these ‘spare’ blastocysts for medical research. The embryo is sacrificed after harvest which raises ethical issues. The main issue being the philosophic question, “When does life begin?”. The FDA does not allow embryonic stem cells to be used in the United States.
The other sources of stem cells come from a category called Hematopoietic. This is blood derived. These are all Mesenchymal Stem Cells and are pluripotent. There are 4 areas where stem cells are collected:
Venous – Blood is collected prior to chemotherapy and radiation and then processed through a process called apheresis to isolate the stem cells. These are then reinfused intravenously after the patient undergoes treatment to reestablish hematopoietic function where bone marrow or the immune system has been damaged or defective.
Bone Marrow – This is the most well known source of stem cells. Blood is aspirated from the pelvis bone marrow which is a rich source for stem cells. This is an invasive procedure that requires a minor surgical procedure. Once the blood is collected it is placed in a centrifuge to isolate the stem cells. These are then reinjected into the patient. The efficacy or quality, of the stem cells are dependent on the age of the patient. Unfortunately, the efficacy of the stem cell decreases with the donors age.
Adipose – Unlike bone marrow-derived mesenchymal stem cells, adipose stem cells can be obtained from abundant adipose tissue by a minimally invasive procedure, which results in a high number of cells. This too is an invasive procedure but less painful than Bone Marrow aspirate. Again, the efficacy of the stem cells is they are dependent on the age of the patient.
Umbilical Cord – This has been shown to be the best source of stem cells. These cells are collected from the umbilical cord after live cesarean birth and are cryopreserved for later use. At this stage there are no antigens so there is no rejection from donor to host. The cells are Day 0 in life and are the most potent that they can be.
What We Do
At Advanced Joint Replacement Center of Southern Oregon we use umbilical cord stem cells and amniotic products. This source for mesenchymal stem cells is selected because we believe that this is currently the best source of stem cells and growth factors available. This choice is based on exhaustive examination of the available research that has been performed throughout the world.
We obtain our HCT/Ps from Predictive Biotech, a Salt Lake City Utah based company that harvests and prepare these products for homologus use. These products have been certified using flow cytometry to contain 1 million+ viable stem cells for implantation. The products we use are:
Corecyte – Minimally manipulated stem cells derived from the umbilical cord. It is intended to repair and regenerate damaged tissue. The umbilical cords are donated from healthy mothers who have had a c-section and follow all the FDA guidelines regarding tissue procurement.
Polycyte – Minimally manipulated tissue suspension derived from Wharton’s Jelly of the umbilical cord. This contains a higher concentration of hyaluronic acid up to 50x.
Amniocyte – minimally manipulated amniotic fluid matrix that is a match for joint fluid. It exhibits anti-scarring, anti-adhesion and anti-inflammatory properties.
On December 23, 2014, the FDA announced a new draft guidance document entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products”. The draft guidance document advises manufacturers of human cells, tissues, and cellular and tissue-based product (HCT/P) products and healthcare providers of the FDA’s current policy on the minimal manipulation criterion of 21 C.F.R. § 1271.10(a)(1).
- For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; and
- For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
Whether a HCT/P is more than minimally manipulated is of utmost importance when assessing the regulatory status of a HCT/P product. Under 21 C.F.R. § 1271.10(a), for an allogeneic HCT/P product to qualify as a HCT/P that does not require a biologics license application or new drug approval, the product must meet four criteria: (1) it must be minimally manipulated, (2) it must be intended for homologous use, (3) the manufacturing, with some exceptions, “does not involve the combination of the cells or tissues with another article,” and (4) the product “does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function.”
Getting stem cells injected into the joint is a very fast and typically a painless procedure. It is as simple as getting any other injection. No blood collection is involved. No machines are involved. The products are taken out of cryopreservation and thawed in a specialized warmer for 5 minutes at which time they are ready for use.
- The joint to be injected is isolated, prepped in a sterile fashion and draped to keep the area sterile.
- An anesthetic is injected into the area to decrease needle penetration pain.
- A small gauge needle is guided ultrasound into the joint.
- The HCT/P products are then injected
- An elastic bandage is place over the penetration site if necessary
- This whole process takes approximately 20 minutes. The patient leaves immediately after the procedure with little to no down time.
Cost of Procedures
This cost is significantly less than the cost for surgeries, not to mention the cost often associated with the prolonged recovery periods and inability to work. A stark contrast can be appreciated when comparing the average cost of a knee replacement in the United States, $31,124, with the cost of our procedure. This is only for the surgery. Also, many people don’t have insurance, their insurance plans don’t cover many of the potential surgeries, or they have high deductibles that haven’t been met. Unfortunately, at this time most insurance companies still won’t cover regenerative medicine treatments that Advanced Joint Replacement Center of Southern Oregon provides. This will likely change in the future when the insurance companies recognize the significant savings that they can reap with our procedures compared with the cost of surgery, and the excellent success rates and patient satisfaction that is currently being seen.