YORBA LINDA, Calif., March 1, 2019 /PRNewswire/ -- Liveyon, the global leader in regenerative medicine, today announced the availability of Liveyon PURE® trial grade stem cell concentrate derived from umbilical cord blood. Manufactured at Liveyon Labs, the company's own FDA -registered and cGMP compliant facility, containing 2 ISO-7 certified cleanrooms, the PURE Product® sets a new industry standard for characterization and consistency in live total nucleated cell counts, viability, purity and safety.
Marketed for physicians treating patients suffering from orthopedic pain and injuries, the stem cells found in the Liveyon PURE Product® may help regenerate bone, muscle, and cartilage and release a host of reparative growth factors and proteins. PURE® is concentrated at 10 million live total nucleated cells and is recommended for a single joint injection or small area, while PURE PRO® contains 30 million live total nucleated cells and may be used for larger areas or for up to three joints in the same patient.
Liveyon CEO John W. Kosolcharoen believes that while the stem cell industry has made impressive strides in recent years, a key element in advancing regenerative applications for cord blood going forward will be thorough characterizations that describe the cell preparation and composition of products in greater detail.
"Surprisingly, only a small minority of clinical studies characterize the stem cells used," said Kosolcharoen. "One meta-analysis I read looked at studies where bone marrow aspirates were used in the clinic and less than 20 percent of the studies cited a cell count or characterization. In contrast, I'm proud that Liveyon provides a detailed description of cell viability, identity, growth factor expression, and safety testing."
Liveyon is able to provide better characterization than ever before due to its decision to move manufacturing from an outside vendor to its own laboratory, enabling it to have full control of the production process in a facility that exceeds current Good Tissue Practice (cGTP) requirements. The PURE Product® is the first product to come out of Liveyon Labs, which features two certified ISO 7 dynamically and statically monitored clean rooms, a series of ISO 5 biosafety cabinets, as well as the latest testing and measurement equipment.
"It has taken Liveyon more than two years to develop the PURE Product®," said Dr. Margaret Coutts, Senior Scientist at Liveyon Labs. "Standard operating procedures (SOPs) were put in place around the strict guidelines of the FDA and the direction the industry was taking. From donor screening and testing, to the sterile techniques applied during umbilical cord blood collection, as well as validation of laboratory processes, every step of the way is conducted following those strict standard operating procedures."
Safety has always been a primary concern for FDA compliance and Liveyon's culture has always been to go above and beyond every current guideline in order to ensure a clean and sterile product, free of contamination and cellular debris that can cause negative reactions in patients. Liveyon has placed tremendous effort to avoid this in the PURE Product®. For example, Liveyon has developed proprietary methods of removing red blood cells and blood matching proteins from cord blood to a minimally irrelevant number without damaging the rest of the cells.
"Many regenerative medicine manufacturers have overlooked the importance of high viability," said Coutts. "They claim that it does not matter if a high percentage of cells are not viable as long as the total number of live cells is large enough. However, research has shown that dead cells have the potential danger to trigger a serious inflammatory response. Liveyon has worked hard in order to achieve the highest viability seen in a regenerative medicine product."
Liveyon's stringent requirements mandate that all products pass USP 71 sterility testing, wherein cultures for bacteria, mold and fungi are incubated for 14 days. This is very significant, since some E. coli strains may not be detected before 7 days. With the PURE Product®, Liveyon is also introducing a new 1cc vial that incorporates a simple puncture top instead of a screw cap.
"With the introduction of the puncture top, we've been able to eliminate what we feel is a lot of risk in the field," added Coutts. "Recently a doctor opened a vial with the old screw top, set the vial down on the table, which he bumped, causing him to lose the whole thing. With the new top the doctor just has to pop off the plastic covering, clean the top of the rubber stopper with an alcohol swab, insert a hypodermic needle into the stopper and draw the cells."
In order to be considered suitable for clinical trials, a product must be consistent, which means it should have the same cell counts, viability and purity in every vial. The only way to achieve this is by creating and following strict protocols in every step of the manufacturing process. Every room, each piece of equipment, and all processes have been validated and certified for the production of the PURE Product®.
Liveyon's world-class team is composed of leading scientists, clinicians, and highly published Ph.D. cellular biologists with over 100 years of combined experience in primary cell culture, molecular biology, and cellular therapy product manufacturing. Liveyon Labs also has an experienced team of compliance and regulatory personnel who work closely as a unit to ensure seamless and compliant integration of the entire process.
"After years of achieving the highest levels of scientific research and development, we have succeeded in implementing an even more robust biological product to join the front line in helping injury and pain patients," said Kosolcharoen.
Liveyon has recently published a study [Pure® White Paper] that characterizes a heterogeneous population of cells in the PURE® and PURE PRO® cell suspension. Results showed that cell viability is high in all steps of the process: in the cord blood unit upon receipt, after product isolation, and after freezing and thawing (89.4 percent, 88.7 percent and 80.8 percent, respectively). While all cell types exposed to processing, freezing and thawing have loss -- which is true for all delicate cord blood cells -- Liveyon's proprietary isolation and cryopreservation process helped maintain high cell viability and reduce cell loss. Furthermore, the survival rate stayed high, even when the thawed cells were maintained in non-ideal conditions, i.e. at room temperature or in cryopreservative.
Liveyon also set out to characterize cell types present in the collected cord blood and in the finished PURE Product®. White blood cells from the cord blood were retained while the red blood cells were eliminated in Liveyon's proprietary processing method. RBC precursors like nucleated RBC and reticulocytes were also removed, while the hemoglobin levels dropped to undetectable levels. Flow cytometry indicated the presence of stem and progenitor cells (CD 34, 73 and 90); a variety of immune cells (CD 45 and 19) and endothelial cells (CD 31 and 34). An analysis of replicated samples showed that the PURE Product® has great lot-to-lot consistency in their production of growth factors and the potent anti-inflammatory IL-1RA.
"It's not enough for manufacturers to provide detailed characterizations, but also prove that they can produce those characterizations consistently," said Dr. Alan Gaveck, Liveyon's director of education. "The world of regenerative medicine is rapidly changing, so it's sometimes difficult to compare the cell counts, viability, purity and safety of one manufacturer's product over another's. With its documented and repeatable characterizations, Liveyon's PURE Product® greatly increases the probability for true, reliable and more effective healing for patients."
© 2019 Liveyon, LLC. . All rights reserved. These statements have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.