A Colorado company and the Food & Drug Administration may finally be headed to court for a showdown the firm calls a referendum on the watchdog agency’s stance on stem cell regulation.

The FDA wants an injunction against Broomfield, Colo.-based Regenerative Sciences LLC to stop it from using a cultured stem cell product as part of a procedure the clinic uses to treat patients with acute orthopedic ailments, which the agency said is “not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.”