The study showed that hypoxic culturing improves mesenchymal stem cell properties and positively influences whole genome expression profiles in reference to the development of cellular therapies targeting the microenvironment of the intervertebral disc.
The FDA authorized BioRestorative to move forward with a phase two clinical trial using hypoxic cultured bone marrow-derived mesenchymal stem cells in its lead candidate, BRTX-100, to treat chronic lower back pain.
BRTX-100 is cell therapy product formulated from autologous cultured mesenchymal stem cells collected from the patient’s bone marrow. The cells would then be isolated, cultured and cryopreserved before being injected into the patient’s damaged disc in an outpatient procedure.
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