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At Pure MSC (Mesenchymal Stem Cell), we embrace the dynamic nature of regenerative medicine, where advancements and discoveries are continuously evolving. As a trusted nationwide distributor, with 10 years of clinical experience, we've cultivated partnerships with the industry's leading manufacturers committed to pioneering innovation & enhancing existing technologies. Together, we remain steadfast in our commitment to staying at the forefront of emerging biological technologies, ensuring that patients benefit from the latest breakthroughs in the field.
Pure MSC is a pioneering company in the field of regenerative medicine, specializing in the production and distribution of high-quality human umbilical cord-derived mesenchymal stem cells (hUC-MSC).
. We look forward to embarking on this journey together and making a meaningful impact in the lives of patients worldwide.
To Deliver a New Class of Living Therapeutics with Greater Potential to Treat Incurable Diseases: Our established platforms enable us to deliver clinical-grade "off-the-shelf" Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC) from the unlimited source cord tissues that are traditionally regarded as medical waste. We embrace the advantages of hUC-MSC over MSC derived from other adult issues including non-invasive procedure to the donor, robust proliferation, high ex vivo scalability and superior biological activities, etc. Our product is made fresh to order in a cGMP lab. With over a decade of clinical experience, Pure MSC has established partnerships with leading manufacturers in the industry, focusing on innovation, technological enhancement, and the delivery of clinical-grade "off-the-shelf" hUC-MSC. Their products, known for their potent therapeutic potential, aim to regulate the immune system, reduce inflammation, and promote the recovery of injured and diseased tissues.
Our product DOES NOT contain harmful or dangerous Preservatives unlike those found in frozen stem cells. By avoiding freezing altogether, we kindly request orders to be placed one week in advance to ensure fresh production with overnight delivery. Coordination is crucial as the fresh cells must be administered within 24 hours of arrival.
Our clinical-grade Mesenchymal Stem Cell products are IND registered. They have been extensively studied in preclinical and clinical research for their ability to promote healing and modulate immune responses in conditions such as orthopedic injuries, autoimmune diseases, and inflammatory disorders & more.
To maintain the utmost potency, we exclusively utilize allograft tissue cells sourced from human umbilical cord blood; donated & screened healthy mothers, delivering babies via cesarean sections. MSC's are considered more potent than PRP & adult stem cells due to their unique properties & their ability to differentiate into multiple cell types and their immunomodulatory effects.
Our stem cell product boasts an impressive 95-100% viability (the percentage of surviving cells), optimizing its efficacy for your patients. This stands in contrast to the post-thaw 70% or less reported in other frozen stem cell products. Our established technology enables us to manufacture clinical-grade "off-the-shelf" Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC).
Manufacturing occurs at a state-of-the-art cGMP facility equipped with FDA-certified clean rooms, a flow cytometry core, and ultra-centrifuges to our esteemed physicians and patients. Vigorous screening & processes to ensure the highest standards of quality and safety.
Undergoing meticulous processing, testing, and certification procedures before distribution. Regulated by the FDA under 21 CFR Part 1271 and Section 361 of the Public Health Service Act. Placental donors go through a rigorous screening qualification process that are tested for infectious diseases.
High-quality human umbilical cord-derived mesenchymal stem cells (hUC-MSC), produced from our proprietary technology platforms, possess superior therapeutic potential to regulate immune system, inhibit inflammation and promote the recovery of injured and diseased tissues. Our hUC-MSC drug delivery system utilizes the precise targeting ability of hUC-MSC to increase the delivery efficiency while reduce the off-target side effects of systemically administrated medicines. Our technology platform has the potential to address multiple incurable diseases with significant unmet market needs.
Discover the future of regenerative medicine with our innovative stem cell product. Our fresh, never frozen mesenchymal stem cells are revolutionizing the field, offering new possibilities for patient care and treatment plans.
Our cGMP facility offers globally harmonized GMP-compliant cell therapy manufacturing infrastructure with controlled flow of personnel and materials and environmental monitoring, ensuring the highest level of quality control and risk mitigation for product manufacturing.
Features of our clean room include:
We have a patent portfolio covering hUC-MSC based technologies and other proprietary regenerative product candidates and technologies, as well as for elements of our GMP manufacturing processes. We will continue to protect and expand our extensive estate of patent rights and trade secrets. We believe this enables us to deliver commercial advantages and long-term protection for our product candidates based on our proprietary technologies.
PURE LLC
Cells@PureMsc.com
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