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We administer 300 million culturally expanded umbilical cord tissue-derived mesenchymal stem cells (MSCs)

Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug/biologic products by requiring that our partner lab in the United States adequately controls manufacturing operations.

Cell viability refers to the number of live, healthy cells in a sample. Cell viability assays are used to measure the physical and physiological health of cells in response to extracellular stimuli and ensure every patient receives the same dosage (300m MSCs).

A Certificate of Analysis (COA) is a document that communicates the results of scientific tests done on the cells prior to infusion. The COA is created to ensure all important regulations are met and complied with.

ISCT is the global leader focused on translational aspects of developing cell-based therapeutics, advancing scientific research into innovative treatments for patients. The ISCT definition dictates that MSCs should have ≥95% surface marker expression.

In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.