Background and purpose – The value of core decrompression for treatment of osteonecrosis of the femoral head (ONFH) is unclear. We investigated by a literature review whether implantation of autologous bone marrow aspirate, containing high concentrations of pluripotent mesenchymal stem cells, into the core decompression track would improve the clinical and radiological results compared with the classical method of core decompression alone. The primary outcomes of interest were structural failure (collapse) of the femoral head and conversion to total hip replacement (THR). Patients and methods – All randomized and non-randomized control trials comparing simple core decompression with autologous bone marrow cell implantation into the femoral head for the treatment of ONFH were considered eligible for inclusion. The methodological quality of the studies included was assessed independently by 2 reviewers using the Cochrane Collaboration tool for assessing risk of bias in randomized studies. Of 496 relevant citations identified, 7 studies formed the basis of this review. Results – The pooled estimate of effect size for structural failure of the femoral head favored the cell therapy group, as, in this treatment group, the odds of progression of the femoral head to the collapse stage were reduced by a factor of 5 compared to the CD group (odds ratio (OR) = 0.2, 95% CI: 0.08-0.6; p = 0.02). The respective summarized estimate of effect size yielded halved odds for conversion to THR in the cell therapy group compared to CD group (OR = 0.6, 95% CI: 0.3-1.02; p = 0.06). Interpretation – Our findings suggest that implantation of autologous mesenchymal stem cells (MSCs) into the core decompression track, particularly when employed at early (pre-collapse) stages of ONFH, would improve the survivorship of femoral heads and reduce the need for hip arthroplasty.
: Mesenchymal stromal cells (MSCs) have been investigated as a treatment for various inflammatory diseases because of their immunomodulatory and reparative properties. However, many basic questions concerning their mechanisms of action after systemic infusion remain unanswered. We performed a detailed analysis of the immunomodulatory properties and proteomic profile of MSCs systemically administered to two patients with severe refractory acute respiratory distress syndrome (ARDS) on a compassionate use basis and attempted to correlate these with in vivo anti-inflammatory actions. Both patients received 2 × 106 cells per kilogram, and each subsequently improved with resolution of respiratory, hemodynamic, and multiorgan failure. In parallel, a decrease was seen in multiple pulmonary and systemic markers of inflammation, including epithelial apoptosis, alveolar-capillary fluid leakage, and proinflammatory cytokines, microRNAs, and chemokines. In vitro studies of the MSCs demonstrated a broad anti-inflammatory capacity, including suppression of T-cell responses and induction of regulatory phenotypes in T cells, monocytes, and neutrophils. Some of these in vitro potency assessments correlated with, and were relevant to, the observed in vivo actions. These experiences highlight both the mechanistic information that can be gained from clinical experience and the value of correlating in vitro potency assessments with clinical effects. The findings also suggest, but do not prove, a beneficial effect of lung protective strategies using adoptively transferred MSCs in ARDS. Appropriate randomized clinical trials are required to further assess any potential clinical efficacy and investigate the effects on in vivo inflammation.
This article describes the cases of two patients with severe refractory adult respiratory syndrome (ARDS) who failed to improve after both standard life support measures, including mechanical ventilation, and additional measures, including extracorporeal ventilation (i.e., in a heart-lung machine). Unlike acute forms of ARDS (such in the current NIH-sponsored study of mesenchymal stromal cells in ARDS), recovery does not generally occur in such patients.
If you suffer from chronic knee pain due to arthritis or an old injury, or you’ve recently injured your knee meniscus, cartilage or ligaments (ACL, MCL) you may benefit from non-surgical stem cell injections or stem cell-enhanced surgery.
About the Knee
The knee is the joint where the bones of the upper leg meet the bones of the lower leg, allowing hinge-like movement while providing stability and strength to support the weight of the body. Flexibility, strength, and stability are needed for standing and for motions like walking, running, crouching, jumping, and turning.
Several kinds of supporting and moving parts, including bones, cartilage, muscles, ligaments, and tendons, help the knees do their job. Each of these structures is subject to disease and injury. When a knee problem affects your ability to do things, it can have a big impact on your life. Knee problems can interfere with many things, from participation in sports to simply getting up from a chair and walking.
Stemnexa combines a patient’s own bone marrow stem cells with AlphaGEMS amniotic membrane tissue to treat bone, muscle, tendon, ligament and cartilage damage in the knee. AlphaGEMS is composed of collagens and other structural proteins, which provide a biologic matrix that supports angiogenesis, tissue growth and new collagen production during tissue regeneration and repair.
Learn more about which conditions RMI can offer treatment for.
UCLA wide receiver and Canadian decathlon standout Zach Bornstein suffered a hamstring tear 18 months ago. Conventional treatment and therapy were not working so Zach decided to undergo stem cell therapy at Riordan-McKenna Institute in late June 2015. Dr. McKenna treated Zack with precisely guided injections of bone marrow aspirate concentrate (BMAC) harvested with the patented BioMAC bone marrow aspiration cannula and *AlphGEMS amniotic tissue product.
Complete healing was confirmed by MRI 8 weeks after treatment:
1) No evidence for hamstring strain or denervation and no evidence for tendon tear.
2) No evidence for focal atrophy or hematoma.
3) No osseous abnormalities seen.
After receiving the MRI results, Zack’s father Dean said, “I am not a doctor but looks like you and your procedure has performed a medical miracle! …Thanks for all of your efforts.”
Zack is currently a red shirt freshman at UCLA. He played football at Oaks Christian High School from 2011-’14 and lettered 3 years in football and all 4 years in track. In 2013, Zack was named to the All-Marmonte 2nd team. He played in the FBU Youth All-American game in 2010. In track, he is considered to be one of the top decathletes in the country. Zack competed at the 2013 Pan American Junior Championships in Medellin, Columbia, finishing in 5th place with 7,097 points. In July of 2013, he became the Canadian Junior National Champion (6,918 pts). Zack won the silver medal at the 2013 Arcadia Invitational Decathlon, scoring 6,967 points to set a new California state record for juniors (2nd highest score in California state history). Zack is a 12-time National Champion, 44-time All-American and a member of three National Championship cross country teams.
*Amniotic tissue is donated after normal, healthy births.
Authors Neil H Riordan, Ben A George, Troy B Chandler, Randall W McKenna
Non-healing wounds can pose a medical challenge as in the case of vasculopathic venostasis resulting in a surgical ulcer. When traditional approaches to wound care fail, an amniotic patch (a dehydrated tissue allograft derived from human amnion) can function as a biologic scaffold to facilitate and enhance tissue regeneration and rehabilitation.
Amniotic AlphaPatches contain concentrated molecules of PGE2, WNT4, and GDF-11 which have angiogenic, trophic, and anti-inflammatory effects on tissues that may be useful in enhancing wound healing.
We present a case of a severe non-healing surgical wound in a 78-year-old male 17 days post right total knee arthroplasty. The full-thickness wound exhibited a mobile flap, measured 4 cm long × 3 cm wide, and showed undermining down to patellar tissue. We treated the wound conservatively for 6 weeks with no evidence of wound healing. Upon failure of the conservative treatment, two amniotic AlphaPatch (Amniotic Therapies, Dallas, TX, USA) were applied to the wound, and the wound healed completely in 10 weeks.
In the OR, the wound was irrigated with three liters of double antibiotic solution under pulse lavage. Two dry amniotic AlphaPatch (4 cm × 4 cm) were placed over the wound with Acticoat applied on top.
At the two-week follow-up visit (following the incision and drainage of the wound dehiscence and application of the amniotic AlphaPatch), a central scab had formed centrally in the wound dehiscence area. At the four-week follow-up visit, the wound dehiscence area had completely scabbed over with no open areas left. At the eight-week follow-up visit, the scab had just fallen off, and the wound was healing well with immature skin representing the size of a penny. At the ten-week follow-up visit, the wound was completely healed.
Sterile, dehydrated amniotic tissue AlphaPatches (containing trophic factors known to enhance wound healing) have proven effective in completely healing an otherwise non-healing wound in a 78-year-old male who failed six weeks of conservative wound care treatment.
“As many of you know I had stem cell therapy for MS in 2012. In 2014 I had platelet rich plasma injections in my heel for plantar fasciitis with a full recovery! This past year I had an ACL injury after a skiing accident. Traditional surgery offered me a 9 month recovery time. NOT ACCEPTABLE! I’m a busy girl! Using a bone marrow aspirate taken from my hip and AlphaGems, Dr. McKenna had me hiking, biking, walking and enjoying life after 1 month! Total recovery in 6 weeks! This is my doctor, Dr. R Wade Mckenna talking about the increasing use of Stem Cell Therapy changing the way orthopedic surgeons treat patients. As we age, the wheels do start to fall off! HA! So if you have a knee injury, back problems, or an orthopedic condition of any kind, I can’t recommend the Riordan-McKenna Institute in Southlake, Tx. enough! I’ve chosen my own cells 3 times now! It’s a total #NoBrainer! #ChooseYourOwnCells every time!” –Jennifer Wininger Ziegler
Over the last five years, R. Wade McKenna, DO, founder of North Central Texas Orthopedics and Sports Medicine of Decatur, Texas and McKenna Orthopedics of Trophy Club, Texas, has treated over 3,000 patients with point-of-care Autologous Biologic Therapy (ABT). ABT is the use of a patient’s own regenerative cells and other growth factors to promote and accelerate the body’s natural healing cascade. With the recent news of high profile athletes such as Alex Rodriguez, Kobe Bryant, Tiger Woods and Peyton Manning traveling overseas for similar treatment, we asked Dr. McKenna if this technology is unavailable or unapproved in the United States.
Dr. McKenna replies with a chuckle, “Neither of those assumptions is true. In fact, I began using point-of-care Autologous Biologic Therapy to aid in the healing of rotator cuff surgeries more than five years ago. My initial use of ABT was directed toward improving surgical results only in rotator cuff surgery. However, the positive effect the addition of this biologic therapy had on rotator cuff surgical outcomes was so impressive I began to expand the use of this novel treatment to other difficult-to-treat injuries and conditions. The only reason I can think of as to why these athletes went overseas is because they’ve never heard of my practice in Decatur, Texas.”
The use of a patient’s own growth factors derived from platelet-rich plasma (PRP) has been a popular treatment for sports related ligament and tendon injuries. McKenna adds, “Initially the focus centered on the wound care market where PRP showed promising results. We began to understand the healing powers found in whole blood, and early adaptors such as myself incorporated the therapy into our patient care protocols. For Kobe Bryant and Alex Rodriguez, their treatments contained stem cells not found in whole blood. Most of the physicians in the U.S. don’t have experience in point-of-care Autologous Biologic Therapy so high-profile athletes such as these seek treatment with cultured stem cells in Europe.”
Both Bryant and Rodriguez were seeking a clinical culturing process of their own stem cells to achieve a desired number of these regenerative cells that would produce a positive outcome. In the U.S., the FDA has yet to approve stem cell culturing for the purpose of treating these injuries, causing most Americans to seeking this treatment to travel overseas.
In Decatur, Texas, Dr. McKenna uses a centrifuge to achieve similar large numbers of regenerative cells and administers them to his patients in an FDA approved point-of-care procedure. The processing is done while the patient is undergoing treatment for his/her injury and takes less than 25 minutes. In Europe the cells are cultured in a laboratory and administered to the patient two to three days later, which is a procedure that is not FDA approved.
The method Dr. McKenna uses to acquire a patient’s regenerative cells from his/her bone marrow does not require culturing. “I began utilizing regenerative cells in point-of-care treatments for orthopedic related complications over five years ago. Back then I was limited to surgical applications due to the archaic method of bone marrow harvest and the lack of a sophisticated processing device. The new Bio-MAC bone marrow aspiration cannula from Biologic Therapies changes all that,” says McKenna.
Previous to recent advances in technology by Biologic Therapies, Inc. (BTI), obtaining bone marrow aspirate was a difficult and painful process using a hammer-driven cannula (needle). “I was fortunate to have a business contact that was focused on bringing marrow harvesting and processing out of the dark ages. Together, we collaborated on designing a state-of-the-art harvesting device, the Bio-MAC Bone Marrow Aspiration Cannula, as well as developing a centrifuge system capable of concentrating millions of regenerative cells from the blood products in the harvested marrow. I’m very proud of our development and feel BTI’s Bio-MAC will revolutionize the emerging point-of-care Autologous Biologic Therapy market,” said McKenna.
Dr. McKenna has joined forces with Biologic Therapies of Ocala, Florida. “Biologic Therapies is our medical think tank,” explains McKenna. “We are now able to further the advancement of Autologous Biologic Therapy while promoting the business of point-of-care regenerative medicine. No other company I’m aware of combines the two.” Point-of-care refers to the process of harvesting regenerative cells from bone marrow and reintroducing those cells back into the patient is one, quick procedure without any culturing of the cells.
With the use of technology he developed with Biologic Therapies, Dr. McKenna has successfully drawn regenerative cells from the bone marrow of his patients in an in-office setting. These new advancements have made obtaining bone marrow aspirate and the use of regenerative cells a much easier and cost efficient point-of-care process.
One of the most innovative uses of bone marrow aspirate concentrate, which was pioneered by Dr. McKenna, involves treating arthritic knees. “Arthritis is technically just the absence of articular cartilage covering the joint surfaces. Many times small arthritic lesions develop which are called osteochondral defects. These defects often progress to severe changes involving the entire joint,” explains McKenna.
Currently, the standard of care for these osteochondral defects or arthritic lesions is a surgery called microfracture. In microfracture surgery an arthroscopic procedure is performed to create small fractures through the underlining cancellous bone to treat the defect. These small holes help promote healing by the liberation of small amounts of bone marrow within the joint.
“My initial thought involving this process was that if small drops of liberated bone marrow aided in healing of these lesions, what would the addition of active regenerative cells from concentrated bone marrow aspirate be capable of doing?” states McKenna. This thinking led to the development of a protocol to treat patients with not only isolated osteochondral lesions, but also to treat patients with more severe osteoarthritis.
Dr. McKenna adds, “The growth of articular cartilage is common in children as they develop into adults and cartilage volume increases. Unfortunately, the growth of articular cartilage in adults is rare and treatment for the loss of cartilage has been focused on replacing or fusing these arthritic joints.”
The use of Autologous Biologic Therapy in a solution of concentrated growth factors has brought new hope to patients suffering from worn out arthritic joints. “The procedures we are developing are very similar to the stem cell therapy procedure Kobe Bryant, Tiger Woods and Alex Rodriguez received in Europe. Our clinical results are showing a rejuvenation of the knee’s overall function. MRI and standing x-rays confirm the space between the bones (cartilage area) is increasing. It’s early in the development stage, but if my use of regenerative cells continues to produce such positive outcomes, it’s quite possible we will have developed a new standard of care for millions suffering from arthritis,” says McKenna.
I also wanted to know if high-profile athletes, or those dreaming of being one (weekend warriors), were the only people who will benefit from this emerging point-of-care regenerative medicine?
McKenna answers, “I believe that almost any patient undergoing surgery can expect improved surgical results with this technology. This is evidenced by the fact that the most frequent application of regenerative cells is found in spine surgery. Surgeons utilize the phenomenal healing characteristics of regenerative cells to increase the formation of bone and aid in the formation of the fusion mass. The results of spinal fusions have been dramatically improved with the use of regenerative cells derived from bone marrow aspirate concentrate.”
McKenna goes on to explain, “Fractures that fail to heal are called non-union fractures and this is one of the most challenging issues in orthopedic surgery. The use of regenerative cells to heal these fracture non-unions continues to evolve. I have used mesenchymal stem cells with great success to aid in the healing of non-union fractures involving the clavicle, tibia and metatarsal bones of the foot.”
As a trained Trauma specialist, Dr. McKenna takes Emergency Room calls and sees many broken hips. Most of these fractures occur in elderly women who suffer from osteoporosis. “The introduction of bone marrow aspirate concentrate to augment the fixation of hip fractures has, in my clinical experience, increased the viability of the femoral head. I have seen 80-year-old patients walk into my office following hip fracture surgery with a femoral head that, on x-ray, looks unaffected by their previous fracture. Prior to the use of bone marrow aspirate concentrate this result would be uncommon,” states McKenna.
As we concluded the interview Dr. McKenna added with a great voice of confidence, “Certainly the future of orthopedics and all the surgical subspecialties will involve the use of regenerative biologics like stem cells. Unlocking the body’s ability to heal itself is the real future of patient care. I am proud to be involved as an innovator in this emerging technology.”
Ocala, FL (May 12, 2015) – Biologic Therapies, a medical device company specializing in the design and development of products for regenerative medicine, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Bio-MAC and Bio-CORE cannulas. The Bio-MAC Bone Marrow Aspiration Cannula and Bio-CORE Bone Marrow Biopsy Cannula are minimally invasive devices that are inserted into bone with any standard surgical drill.
Bio-MAC Bone Marrow Aspiration Cannulas Bio-CORE Bone Marrow Biopsy Cannulas
Dr. Wade McKenna, Biologic Therapies’ Chief Medical Director, said, “Unlike traditional bone marrow aspiration cannulas, which are pounded into bone with a mallet or pushed in with brute force, the power driven Bio-MAC and Bio-CORE do not cause microfractures in the bone that can result in pain for the patient. Plus, the Bio-MAC and Bio-CORE are available in multiple lengths, which allow for fast and easy bone marrow draws throughout the anatomy. In addition to the iliac crest and lumbar vertebral body, the tibia, humerus and calcaneus are now viable sites for bone marrow aspiration.
“Our products enable physicians to aspirate bone marrow in their own office with only local anesthesia, which is revolutionary. The ability to aspirate a patient’s marrow, concentrate the marrow in a centrifuge to derive the maximum number of regenerative cells and growth factors, and then give the concentrated cells and growth factors back to the patient in a physician’s office makes regenerative cell therapy a much easier, more available and less costly procedure. The entire point-of-care procedure takes less than 30 minutes. Of course, the Bio-MAC and Bio-CORE are also used in hospitals and surgery centers.”
AUTOSPIN Centrifuge AUTOSPIN BMAC Convenience Kit
For concentrating bone marrow Biologic Therapies offers its AUTOSPIN centrifuge and convenience kits. The AUTOSPIN is a fully automated dual spin centrifuge that can be programmed to deliver a volume of 3 to 10 ml from each processing cycle. It is a closed system, which dramatically reduces the chance for contamination. Two separate AUTOSPIN Convenience Kits contain all the components needed to process Bone Marrow Aspirate Concentrate (BMAC) or Platelet-Rich Plasma (PRP).
Luke Whalen, Biologic Therapies’ CEO, said, “My team and I are very pleased to receive 510(k) clearance for our Bio-MAC and Bio-CORE cannulas. We are currently expanding our business throughout the United States, Europe, India, China and South Africa. Biologic Therapies is improving the health of patients around the world by making our products the standard of care for regenerative medicine.”
About Biologic Therapies
Based in Ocala, Florida, Biologic Therapies, Inc. (www.biologictherapies.com) (www.amniotictherapies.com) develops innovative technologies to meet the needs of the emerging regenerative medicine segment of the healthcare market. Biologic Therapies’ mission is to provide groundbreaking medical technologies and procedures that significantly enhance the body’s natural healing ability, thereby providing patients with improved outcomes and quicker restoration of function.
Board-certified, fellowship-trained orthopedic trauma surgeon, Wade McKenna discusses how to decide whether a stem cell injection or stem cell-enhanced minimally-invasive surgery is the best course of action for an orthopedic patient