Stem Cell, Ortho-Biologics and Regenerative Medicine Program

All supposedly cutting edge arthritis treatments are not the same. Some arthritis treatments are frankly scams—current day "Snake Oil".  These "arthritis remedies" play on the known variability of arthritis symptoms. If you have knee arthritis, you have noticed that you have some good days, some bad days and some very bad days—with NO change in your treatment. This is the normal course of knee arthritis symptoms—and life for that matter! You can put “Super Salve XX” on your knee or take “Triple Strength Total Arthritis Cure” tablets and, if these bogus “treatments” happen to correspond with the normal cyclic improvement in comfort and function, you might conclude that they work—while, in reality, the improvement is nothing more than the cyclic nature of arthritis symptoms.

Science attempts to separate random chance from real treatment effects. Through rigorous analysis, science attempts to remove the cyclic changes of arthritis symptoms and the variability of patient specific response from the equation. However, in the early days of any treatment, rigorous science lags as long-term outcomes, by definition, take time. Nevertheless, patients are willing to seek improvements in function and pain with new treatments, if the risks are low and the rewards are promising. That is a fundamental goal of the Knee Restoration Stem Cell, Ortho-Biologics and Regenerative Medicine Program.  The program is an evolution of the Cartilage Restoration Center that was conceptualized in 1995 and has grown to involve complete knee restoration including articular cartilage, ligaments and menisci. Patients often present for cartilage restoration, but unfortunately the knee is no longer a candidate for knee restoration. However, we now can offer a potential “bridge” between biologic knee restoration and (artificial) total knee replacement. The Stem Cell, Ortho-Biologics and Regenerative Medicine Program offers state of the art biologic treatment options. To be clear, MOST INSURANCE PROGRAMS, MEDICARE AND MEDICAID label these treatments as “experimental/investigational” and with that designation; they DO NOT pay for these treatments. Consult with your Health Savings Account (HAS) adviser, as prescribed medical treatments may be allowed for payments from your HSA account.

After extensive review of the available stem cell and biologic options, the Knee Restoration Center specialists have developed the Stem Cell, Ortho-Biologics and Regenerative Medicine Program. For those who want biologic treatment, the Stem Cell, Ortho-Biologics and Regenerative Medicine Program offers most internationally recognized and US allowed treatments. All options have been vetted by our team. As these are in the early stages of use, if you elect to participate, we request (not require) that you complete surveys to understand how you respond (or don’t respond) to the treatment. (These are NOT paid surveys. They are voluntary to aid in understanding how to best help future patients.)

Available Program Treatment Options:

  • Stem Cells from Amniotic Fluid and Amniotic Membrane
  • Stem Cells from Bone Marrow Aspirate
  • Stem Cells from Adipose Tissue (Fat)
  • PRP (Platelet Rich Plasma)

Note: Cultured Stem Cells are not allowed for patient use in the US at present per FDA.

These are NOT research studies or clinical trials. Research studies, including those at our center, may be found on the Research page or at clinicaltrials.gov.

Stem Cells

What are stem cells?

Stem cells are a classification of one group of cells in the human body. Unlike specialized, differentiated cells such as cartilage cells, bone cells, fat cells, etc., stem cells are undifferentiated. Responding to various stimuli, they can differentiate into specialized cells. That capacity represents the common public conception: stem cells can regenerate damaged or lost tissues. In the proper setting, this can occur.  However, in most current applications, they are “modulating” cells that help to re-balance the imbalance of pro-inflammation/anti-inflammation and/or tear down/regrowth that may exist, for example, in an arthritic knee.

There are two main types of stem cells: adult stem cells and embryonic stem cells. We DO NOT USE Embryonic stem cells. Embryonic cells are pluripotent meaning they can develop into almost any type of cell in the body.

We use only Non-Embryonic stem cells.  One type is amniotic fluid stem cells, which are cells floating in the amniotic fluid and usually discarded at birth. Adult stem cells are more tissue-specific than embryonic and the most commonly studied are hematopoietic (blood forming cells) and mesenchymal stem cells (MSCs), which form cartilage, bone, muscle, fat, etc. For orthopedics, we are interested the latter, the MSCs, as they form the tissues of interest to us. Once again, at present, the “organ modulation” properties are currently of more interest for managing osteoarthritis symptoms than tissue regeneration though preclinical studies are ongoing and we are in communication with researchers outside the US involved in stem cell cartilage regeneration.

Do stem cells decrease arthritis symptoms? A work in progress...

Our center has been involved with two recent studies investigating stem cells in arthritis and the outcomes are promising. The orthopedic literature is rapidly evolving in this area.

  • Journal of Bone and Joint Surgery (American). 2014. Authors: Vangsness, Farr, et al.
    Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study

    “Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control, on the basis of visual analog scale assessments.”    “…..clinical outcomes at intervals through two years’”
     
  • Journal of Knee Surgery. 2015. Authors: Vines, Aliprantis, Gomoll and Farr
    Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis.
    “Patient-reported outcomes including International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome, and Single Assessment Numeric Evaluation scores were collected throughout the study and evaluated for up to 12 months. Overall, this study demonstrates the feasibility of a single intra-articular injection of ASA for the treatment of knee OA and provides the foundation for a large placebo-controlled trial of intra-articular ASA for symptomatic knee OA.”

Stem Cell Preparations Available:

  • Stem Cells within Amniotic Fluid and Amniotic Membrane
    Cryopreserved and available for same day injection upon rapid thawing.
  • Stem Cells within Bone Marrow Aspirate
    Aspiration from the bone marrow under local anesthetic is separated into a concentrate for injection.
  • Stem Cells within Adipose Tissue (Fat)
    Lipoaspiration under local anesthetic is followed by preparation for injection using Lipogems® system.

Platelet Rich Plasma (PRP)

What is platelet rich plasma?

Blood is composed of a fluid component called plasma that can be separated from the small, solid components (red cells, white cells, and platelets). During tissue injury the platelets aid in clotting blood and as the “first responders” to injury, they contain over a 1,000  proteins called growth factors. These growth factors aid in initiating the healing response.

Platelet Rich Plasma simply means the prepared plasma has many more platelets per volume than the patient’s own whole blood. The concentration of platelets  can be 2 to 10 times greater (or richer) than the patient’s blood and thus more of the growth (and healing) factors.

To prepare PRP, blood is drawn from the patient. The platelets are separated from other blood cells and are concentrated by spinning at high speeds in a centrifuge. The concentrated platelets are then available with the plasma portion for injection.

Does PRP decrease arthritis symptoms? A work in progress...

British Journal of  Sports Medicine. 2015. Authors: Laudy ABBakker EWRekers MMoen MH.
Efficacy of platelet-rich plasma injections in osteoarthritis of the knee: a systematic review and meta-analysis.

  • Comprehensive, systematic literature review.
  • Ten trials were included.
  • In these, intra-articular PRP injections were more effective for pain reduction compared with placebo at 6 months post-injection.
  • Intra-articular PRP injections were compared with hyaluronic acid and showed a statistically significant difference in favour of PRP on pain.
  • Almost all trials revealed a high risk of bias.

"On the basis of the current evidence, PRP injections reduced pain more effectively than did placebo injections in OA of the knee (level of evidence: limited due to a high risk of bias). This significant effect on pain was also seen when PRP injections were compared with hyaluronic acid injections (level of evidence: moderate due to a generally high risk of bias). More large randomized studies of good quality and low risk of bias are needed to test whether PRP injections should be a routine part of management of patients with OA of the knee."