LIVEYON LABS HAS CREATED THE FIRST CLINICAL TRIAL GRADE STEM CELL CONCENTRATE IN THE U.S.A.  

Liveyon LLC is a distributor for the PURE® product line manufactured by Liveyon Labs Inc. Liveyon Labs Inc. has worked diligently over the past two years to design a stem cell concentrate that is manufactured under the strictest safety guidelines set forth by the FDA, in its own cGMP facility, focusing on the highest post thaw viability to achievie unparalleled potency through high live nucleated cell counts, all while following validation protocols that produce an extremely consistent product for the most efficacious outcomes when used in Liveyon’s clinical trials.
Safety has always been a primary concern for FDA compliance and for the end user, your patients. Liveyon Labs 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.

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. At Liveyon Labs every room, each piece of equipment , and all the processes have been validated and certified for the production of the Pure® Products.

Liveyon labs, certified manufacturer

A global leader in Regenerative Medicine
A global leader in Regenerative Medicine Liveyon Labs Inc. is the industry’s answer to the need for an FDA registered and compliant cGMP laboratory which operates under the highest regulator standards with the end goal of actively maintaining its biologics license and filing an investigational new drug (IND) application to manufacture our own product for clinical trials. The industry has been flooded with small startups more interested in the bottom line rather than the science of regenerative medicine. This industry has always been about science and Liveyon being a distributer of Liveyon Labs Inc. is into better science.

Liveyon Labs Inc. 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 and molecular biology. 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. From the time we collect the birth tissue, until the final product is delivered to your door you can always be assured you are receiving the industry’s highest grade regenerative medicine product.

Liveyon Labs has two certified IS07 dynamically and statically monitored clean rooms and a series of IS05 biosafety cabinets in which all of its products are manufactured, ensuring the highest quality control and safety standards in the industry.

Liveyon Labs Inc. PURE® cinema Commercial V.2.

From the PURE® product’s blueprint itself, to how it’s processed for manufacture at Liveyon Labs’ cGMP compliant laboratory, there was no doubt that Liveyon Labs would remain in the business of conducting BETTER science. So, it was obvious that decreasing the probability for potential contaminants and cellular debris in our cellular solution, commonly responsible for adverse immune reactions was always the top priority with the PURE® Product line.

Bio-Engineered to be the cleanest, most effective cellular product on the market.

Safe. It all starts at the source.

The Future of Regenerative Medicine
Liveyon Labs Inc. manufacturing process starts at the source. From donor screening and testing, to the sterile techniques applied during umbilical cord blood collection, as well as validated laboratory processing, every step of the way is conducted following strict standard operating procedures.

Liveyon Labs ensures proper methods are utilized to produce a clinical trial grade cellular therapy product. Learn more about the Pure® Products.

After two years of research and development, which included testing every product in the market and listening to the needs of our physicians, Liveyon Labs has created PURE®, a clinical trial grade stem cell product which will be made available to physicians as well as for use in Liveyon sponsored clinical trials. Liveyon Labs is compliant with the FDA’s Current Good Manufacturing Practice (cGMP) standards.

The Liveyon evolution

Liveyon entered the marketplace in 2016 with the ultimate goal of pushing the existing boundaries of regenerative medicine in all aspects of product research and development, and distribution. Liveyon's dynamic ability to adapt to changing market trends and execute on opportunities has allowed for our exponential growth giving Liveyon recognition on a global scale.
Liveyon is now the most recognized stem cell brand in the world with distribution in the Middle East, Asia, Central and South America as well as treatment centers and research agreements on nearly every continent, Liveyon has truly established itself as the global leader in the regenerative medicine space.
It has taken Liveyon Labs Inc. over two years to develop the first clinical trial grade stem cell product, the PURE® Products. 

STEM CELL OVERVIEW, FEATURING DR. ALAN GAVECK

There are many doctors wanting to practice regenerative medicine but have no access to the required training. Liveyon stands out as the industry leader in providing training and clinical protocols to follow. Whether you are brand new in the industry or a seasoned expert needing the latest trends and updates, Liveyon’s Director of Education, Dr. Alan Gaveck will make these programs available to you. Get to know how he operates and watch the overview video above. Read more about us.

 

 

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This site was intended for education purposes only and strictly for use by medical professionals. The FDA recently re-confirmed, there is only one registered stem cell product, and while there is enormous promise in stem cell therapies, and thousands of ongoing experimental applications trying to establish efficacy, these are not at the point where they would meet the scientific standard.
The FDA has stated:
Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm
This site is not intended for consumers.
If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.
“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body.” Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.
If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm
Stem cell therapies have enormous promise, but the science in each use is still in the developmental stage. Professional judgment and expertise is needed in using stem cells for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies to consult the national health data bases to evaluate current information from clinical trials and the FDA websites on human tissue should also be consulted to get its current evaluation of any therapy.