Pluristem's Therapy for Muscle and Tendon Regeneration May Revolutionize Sports Medicine

Los Angeles, CA / ACCESSWIRE / October 17, 2014 / With football season underway, my thoughts run to player injury and how it keeps good athletes off the field with few options for recovery except the stale advice and medicine doctors offer. Rotator cuff damage is a good example. Surgery is invasive and has serious consequences. Rest and recovery takes months. Whether or not talent will be restored is always a question. Enter the questionable treatments: Regenexx, is a privately-held company pandering to sports superstars with promises of stem cell therapy that can't be substantiated. However, there is an answer - Pluristem (NASDAQ:PSTI - News), a leader in cell therapy, will soon conduct Phase I clinical trials for rotator cuff muscle and tendon regeneration that could bring sports medicine, already a $21 billion industry growing faster than the US GNP, into a new era. Pluristem's cell therapy has already shown efficacy in orthopedic medicine. In a successfully completed Phase I/II trial conducted at Germany's Charite University in Berlin under the auspices of Germany's Paul-Ehrlich Institut, the German equivalent of the FDA, Pluristem's PLX cells showed a 500% improvement over placebo in healing gluteal muscle injury.

The background to Pluristem's human clinicals in orthopedic medicine is impressive. Preclinicals for rotator cuff injury were done by Dr. Scott Rodeo of New York's Hospital of Special Surgery, who is also physician to the New York Giants and US Olympic Swimming Team. Results were successful enough for him to announce that PLX cells have a very good chance of accelerating tendon healing. Pluristem has assembled a very impressive Scientific Advisory Board comprised of Orthopedic Key Opinion Leaders, Doctors who are at the top of their field from institutions including the University of Oxford, Charite Hospital in Berlin, Boston University and Cornell University.

Almost 2 million Americans need surgery each year to repair rotator cuffs, the most common damage to the shoulder in active people. About one-third of patients are dissatisfied with results. Rotator cuff operations aren't cheap and normal activity cannot be resumed for four to six months. Surgery on large tears often cause muscle atrophy that is many times irreversible. Because of these drawbacks, professional athletes, regular recipients of rotator cuff injury, are leading the search for better options.

Stem cells appeal to sports luminaries because they penetrate the swollen wound of a torn muscle or ligament and their anti-inflammatory properties promote faster healing of injuries that keep them out of the game. However, FDA regulations condone only the use of autologous (from the individual) cells with strict procedural limitations, forcing most athletes to seek treatment overseas, where rules are more lax.

Los Angeles Angel Bartolo Colón received one of professional baseball's top honors, the Cy Young Award in 2005, but due to rips in the ligaments of his shoulder nearly quit in 2009, driving him to the Dominican Republic for a stem cell procedure. A few months later Colon was pitching at the top of his game for the New York Yankees with a 93-mile-per-hour fastball. Other professionals have followed his lead, reasoning that even if the treatment didn't work any health risks would be small because the cells involved are autologous.

Kobe Bryant, one of the NBA's best players and Olympian, sought stem cell treatment in Germany for a torn knee. Rehabilitation was quick, and Bryant went on to play a stellar 2012 season praising the power of cell therapy.

Bart Oates, center for the New York Giants during their Super Bowl XXI and XXV wins, sought stem cell treatment in Mexico, as did Peyton Manning, one of the greatest quarterbacks in football history, and Terrell Owens. Oates stated that many players leave the gridiron with lingering injuries that plague them for life, looking desperately for medical treatment that improves joint mobility. Stem cell therapy seemed like a good answer. However, US-based orthopedic surgeons have no control over the quality of stem cells given in other countries and worry about the legality of the clinics.

Whether injected stem cells rejuvenated Colon's arm or restored joint flexibility to others is an open question. Science takes a different view, citing FDA warnings that unapproved autologous stem cell treatment given to athletes could form tumors as the cells multiply and roam to other parts of the body. Animal studies show regenerated tissue from the body's own source is not durable. Scar tissue could develop and cause tendons or ligaments to stick to skin, pulling an even bigger tear in an already serious wound. There is a strong call for more clinical research.

Stem cell charlatans give false hope to professional athletes who respond to pressure from owners, coaches and team sponsors demanding top performance. Ignored is the importance of a thorough review process for safety and effectiveness, and proof that manufacturing is in line with regulations. In 2011 three men were arrested in the US and charged with 15 counts of criminal activity related to making, selling and using stem cells without FDA approval. The three defendants allegedly received more than $1.5 million from patients seeking treatment. Scandals like this only support Pluristem's integrity to follow proper regulatory channels.

Regenexx is an outspoken company promoting sports injury healing through alternative methods, including a popular procedure named PRP (platelet rich plasma) where a player's blood is processed and re-injected hoping that concentrated platelets stimulate stem cells to help the body's natural ability to repair itself. The downside is possible inflammation in the joint following reinjection of the platelets. Regenexx's other offering involves extracting stem cells from bone marrow by poking a long needle into the ileac crest of the pelvis, culturing the cells for two weeks, and re-injecting them at the site of injury in an autologous procedure. This is not FDA approved and occurs only outside of the US, away from the FDA's jurisdiction. My research did not turn up any testimony to Regenexx's long-term durability of results.

Dozens of orthopedic stem cell institutes are sprouting up across the country and more orthopedic doctors are embracing cell therapy, treating hundreds of major sports figures. Believing in the healing properties of stem cells, the Jets' Chris Johnson earlier this year visited the Andrews Institute in Gulf Breeze, FL for treatment to help rebuild a torn meniscus. Bone marrow was extracted but because the FDA forbids any additional processing of cells they were immediately injected into the knee, limiting the number of stem cells to maybe 100,000 - far lower than the amount Pluristem could deliver - and apt to produce poorer results.

Pluristem's allogenic cells are an off-the-shelf treatment derived from human placentas. This means patients don't have to go through the painful process of extracting stem cells from their bones. What makes Pluristem's cells unique is that because they are from the placenta they are immuno-privileged. The placenta is designed by nature to not create an immune reaction in the mother. Therefore, it also does not trigger an unwanted immune response in the patient receiving the cells. When approved, Pluristem's PLX cells should make an already flourishing sports medicine industry skyrocket.

PLX cells from a world-class, multi-country approved manufacturing facility would be easy to get, store, and use. Injections are done intramuscularly so pain and inconvenience is minimized. Clinical data backing up claims and the simplicity of the procedure would grab the attention of every orthopedic surgeon answering requests from their athlete patients. The fear of sketchy treatment will be eliminated. Best yet, players wouldn't have to undergo painful bone marrow extraction, avoiding a procedure that has a lot in common with treating leukemia.

For a $210 million market cap company on track to enter a multi-billion dollar market with explosive growth, Pluristem is a steal. This is in addition to the many other indications addressed by their vast pipeline, also targeting big medical money. PLX cell therapy is far superior to what top athletes now have at their disposal to fix sports injuries; further, players would reap the benefits of fast, durable healing without fear of unpleasant after-effects. Valuation is ridiculously low. By my estimates, shares should be trading between $20-$25 with a present-day market cap of up to $1.7 billion, still far below peers who sport thinner pipelines and lots of 'me-too' drugs that adds nothing to medicine's progress. In light of this, it is my opinion to aggressively accumulate Pluristem shares.

SOURCE: BioMedReports