A recent discovery in the use of stem cells could revolutionize both the diagnosis and treatment of an extremely common knee injury and the first set of human trials has shown very promising results. Scientists from the Universities of Bristol and Liverpool in England have developed what they have named the “living bandage,” which is created from the patient’s own living cells. This cell membrane is then surgically implanted into the center of a meniscal tear, allowing repair cell delivery to the injured site and rapid recovery from the injury.

While this procedure is currently in the prototype phase, researchers are confident that with further research the living bandage could provide relief to millions of knee-injury sufferer and prevent osteoarthritis for future generations of young athletes.

Anterior view of a knee injury which shows a torn cruciate ligament

Background

The meniscus is ostensibly a cushioning wedge of cartilage between the femur (thighbone) and tibia (shinbone). Each healthy knee joint has two menisci. Any activity that puts pressure on (or requires rotation of) the knee joint can potentially damage or tear these delicate but essential pieces of connective tissue. While around 10% of meniscal tears occur in the vascular or “red zone” where adequate blood flow exists, more than 80% of meniscal tearing occurs in the avascular “white zone” of the meniscus, meaning it has practically no blood supply. Without the blood supply, it is nearly impossible for the meniscus to repair itself. This fact makes the process of repairing white zone meniscus injuries a growing market with sizable unmet needs.

The Problem

Meniscal tears are one of the most common knee injuries, especially among athletes. According to Boston’s Children’s Hospital, over 500,000 new cases of meniscal tears are diagnosed every year in the United States alone. High contact sports such as football, rugby, and martial arts increase the risk for this type of injury, but you don’t have to be a professional athlete to be affected. Any activity requiring heavy lifting, squatting or walking can apply sheer forces, which can cause weakening or tearing of the meniscus. Getting up too quickly from a squatting or sitting position or twisting can cause or exacerbate a meniscal tear. This means that a seemingly harmless activity like gardening carries a similar risk of meniscal injury and tear; and a sudden pivot on a basketball court or a hard tackle on the football field.

Meniscal tears are increasingly common in children as well. This is partially due to the fact that children are participating in organized, competitive sports at an earlier age. Children who focus solely on one sport are even more likely to experience a tear, due to the repetitive performance of unnatural body movements that sheer the menisci. Further, the meniscus, like other stressed joint components, degenerates over time and its ability for repair diminishes. And since one’s physical performance declines with age, participation in organized sport as a child or teenager puts adults at a greater risk for meniscal tearing. Individuals with osteoarthritis, a common joint disorder involving pain and stiffness, are also at a greater risk of a knee injury with tearing of the meniscus. So it is apparent that osteoarthritis can contribute to meniscal injury or can be a consequence of the tear.

Vascularized-zone meniscal tears, which represent only a small portion of overall injuries, can be easily repaired by closing the injury site with absorbable sutures, the injury will heal due to an adequate blood flow to the area. Yet, because of the non-regenerative nature of the avascular meniscus due to inadequate blood flow, many sufferers opt to simply have the loose, damaged tissue removed by arthroscopic surgery. While this provides a temporary solution and decreases pain in the short-term, there is an inherent risk associated with the procedure. The two menisci in each knee work as an effective team. The risk of a second tear increases when one is removed since the wedge-shaped menisci shift with the movement of the femur on the tibia to take up the slack and fill the gaps that result from movement. Thus, increased wear and tear on the remaining, overstressed meniscus may cause early onset arthritis, stiffness, and re-emergence of pain. The typical recovery time for an arthroscopic procedure is around six weeks and requires the use of crutches, a knee brace, and extensive physical therapy. It is well-documented that within six years following meniscectomy (full or partial removal of meniscal tissue), arthritic changes are apparent to the patient. This increase of pain and stiffness can often lead to further surgeries, and even a partial or full knee replacement. Almost everyone who chose this treatment option suffered from crippling osteoarthritis in later life.

The Solution

Another treatment option is to simply fix the damaged tissue more effectively. To accomplish this, university researchers collaborated with Azellon Cell Therapeutics, the creators of the living bandage prototype. Azellon is a spin-off company from the University of Bristol focused on research, development, and commercialization of adult autologous (patient’s own) mesenchymal stem cells. These highly-adaptive cells are able to develop into vascular (lymphatic and blood vessels), connective and skeletal (bone and cartilage) tissues. Because the living bandage is created from the patient’s own cells, there is minimal risk of rejection or other implantation-related issues. The procedure involves taking stem cells harvested from the patient’s own bone marrow. The cells are lab cultured (expanded to increase their numbers) for two weeks and then seeded into a “membrane scaffold” which forms the living bandage. This structure helps deliver the cells directly to the injured site. This manufactured bandage of stem cells is surgically implanted at the meniscal cartilage tear and is fixed at the site with sutures to keep it in place during movement to enhance meniscal mending. In spite of the tear being in the meniscal “white zone” area, the living bandage “manufactures” adequate blood supply to facilitate healing and a full recovery from injury by a process of angiogenesis. Further, stem cells can extract enough nutrients from the surrounding tissues.

The Trials

While the living bandage is still in the prototype stage and further research and testing are needed to validate the results of this pilot study, it could provide a solution to the millions of serious knee injury sufferers. Azellon and the University of Bristol recently completed a trial of the living cell bandage technology, with promising results. Five individuals between the ages of 18 and 45 with active avascular meniscal tears were treated. All five patients had intact meniscal structures twelve months following implantation of the membrane with a full range of motion- an uncommon feat with meniscal surgery. Three of the five patients had returned to normal knee functionality within the first twenty-four months following the implantation. These results, proving that full restoration of existing avascular meniscus tissue is possible, were published in the journal: Stem Cells Translational Medicine in its issue of December, 2016.

Future Directions

The Living Bandage stem cell treatment is undergoing future research and development as part of the Innovate UK grant funding project. Azellon is currently exploring options for a modified version of the cell bandage utilizing donor stem cells, which could serve to reduce the overall cost of the procedure and reduce the need for two separate operations and be immediately available for implantation. Once the procedure becomes available to the general public, it could potentially not only improve the quality of life for current knee injury sufferers but prevent younger athletes from crippling osteoarthritic degeneration in later life by addressing the tear itself, rather than undergo costly, potentially destructive meniscectomy surgeries. A spokesperson for Innovate UK said, “Turning stem cell research into clinical and commercial reality requires close collaboration between businesses, universities, and hospitals. It’s great to see this inter-disciplinary approach has lead to such an exciting outcome”.

At Gulf Coast Stem Cell & Regenerative Medicine Center, we applaud the innovative work done by the Universities of Bristol and Liverpool, and pledge to be at the forefront of the interdisciplinary collaboration to bring new and effective treatments to our patients as soon as they become readily available. We are especially interested in the use of adipose-derived (originating in the patient’s pre-existing fat cells) stem cell therapies, which can be directly deployed to the injured site and do not require culturing – hence, a great advantage. We can provide relief of pain, reduce stiffness and improve functionality and quality-of-life from through exceedingly low-risk procedures. Indeed, there is published literature that indicates benefit in patients with meniscal tears. Employing this method, we perform the entire procedure of harvest (by mini-liposuction under local anesthetic) and stem cell deployment into the knee joint (under strict sterile conditions) in less than three hours. The stem-cell-containing stromal vascular fraction (SVF), which is anti-inflammatory, immunomodulatory and regenerative, finds its way into every nook and cranny of the knee joint effecting healing and improvement.

Our talented team of professionals will personalize your treatment. As proud members of the Cell Surgical Network (CSN), you can be assured that we provide top-of-the-line care while helping our patients increase mobility and functionality. We help provide solutions for everything inflammatory, autoimmune or degenerative, ranging from Alopecia to Scleroderma, provide stroke recovery options, relief from Rheumatoid Arthritis, Parkinson’s, and Neuropathy, in addition to a host of degenerative joint complaints. We are part of a giant research project, through the CSN that first addresses the safety, then the benefit, efficacy and predictability of stem cell deployment and outcomes in various disease entities. Our safety record has been published in a peer-review journal, which shows an excellent safety record to the procedure.

Contact Gulf Coast Stem Cell and Regenerative Medicine Center and let us show you what “Excellence with a Human Touch” means. For more information on the full list of diseases and disorders that we currently address, please call (866) 865-4823. Our facility is located at 1153 Ocean Springs Rd., Ocean Springs, MS 39564. Or visit our website at www.gulfcoaststemcell.com.