Table I. Changes in the regulation of cellular therapies Before 2007 (top), cell therapies were registered and activities were accomplished in hospital standard laboratories following a linear pathway for clinical trial approval. Since 2007 (bottom), administrative and quality control measures (legal, technical and medical) along with new pathways and infrastructure (GCP and cGMP) have been necessary for cell therapy use in the clinic and have thus created a complex pathway before new techniques can finally be implemented for patient use. Double control of clinical trials has been introduced by both State and Federal agencies, and pathways for hospital environments are the same as for large pharmaceutical companies.