Axolotl Ambient™ (Investigational New Drug Product)
Axolotl AmbientTM (Clinical Ambient, CA20) is limited by Federal Law to Investigational Use. CA20 an allogeneic amniotic therapy consisting of a growth factor and cytokine-rich fluid, derived from human amnion cells. CA20 is manufactured through in-vitro culture of human amniotic cells, extracted from human amniotic tissue. During culture, the media is conditioned with the secreted factors from the amnion cells, which are comprised of multiple growth factors and cytokines that are key mediators in tissue healing, regeneration, and anti-inflammatory pathways. The conditioned media is collected, frozen and terminally irradiated to ensure no viable cells are included in the final product. Currently, this intra-articular orthopedic therapy is being Investigated by the FDA as a new biologic drug, IND Study #27607. Additional Information can be found at ClinicalTrials.gov NCT05092646.
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