Clinics in Denver, Colorado

Colorado cellular therapy clinics are governed by 21 CFR Part 1271. Section 361 covers minimally manipulated HCT/Ps used for homologous use without need for premarket approval. Section 351 covers products that are more than minimally manipulated, used non-homologously, or combined with another article, and these require an IND for clinical use or a BLA for marketing. Most stem cell, stromal vascular fraction, and exosome therapies marketed for orthopedic, cosmetic, or neurologic conditions in Colorado are Section 351 biologics. The FDA expects compliance regardless of whether the cells are autologous.

• Colorado Medical Practice Act, CRS Title 12, Article 240
  Establishes physician licensure and the Colorado Medical Board's authority over scope of practice and discipline.
• Colorado Naturopathic Doctor Act, CRS Title 12, Article 250
  Defines registered naturopathic doctor scope, which excludes most injectable cellular procedures.
• Colorado Pharmacy Practice Act, CRS Title 12, Article 280
  Regulates compounding pharmacies, including 503A standards relevant to biologic preparation.

The FDA has issued warning letters and inspectional observations to Colorado clinics marketing unapproved stem cell and exosome therapies. The Colorado Medical Board has disciplined physicians for unprofessional conduct related to misleading advertising and substandard care in regenerative procedures. Colorado has not produced a high-profile injunction comparable to the California SVF case, but federal scrutiny of Front Range and resort-area clinics has been steady. The Colorado Attorney General has authority under the Colorado Consumer Protection Act to pursue deceptive trade practice claims against providers making unsupported clinical claims.