Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.

Background: Cardiosphere-derived cells (CDCs) ameliorate skeletal and cardiac muscle deterioration in experimental models of Duchenne muscular dystrophy. The HOPE-2 trial examined the safety and efficacy of sequential intravenous infusions of human allogeneic CDCs in late-stage Duchenne muscular dystrophy.

Methods: In this multicentre, randomised, double-blind, placebo-controlled, phase 2 trial, patients with Duchenne muscular dystrophy, aged 10 years or older with moderate upper limb impairment, were enrolled at seven centres in the USA.

In-practice evaluation of OraVerse for the reversal of soft-tissue anesthesia after dental procedures.

This study investigated the pattern of use, dentist evaluation, and patient assessment of OraVerse (OV), a solution of phentolamine mesylate formulated for intraoral submucosal injection and used for the reversal of soft anesthesia after dental procedures. Participants were provided the drug for treatment of up to 10 patients each and agreed to complete a 26-item evaluation questionnaire at the end of the clinical assessment. Data were available from 51 dentists reporting on 390 patients 4 to 90 years of age.

Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients.

Background: The authors evaluated the safety and efficacy of a formulation of phentolamine mesylate (PM) as a local anesthesia reversal agent for pediatric patients.

Methods: A total of 152 pediatric subjects received injections of local anesthetic with 2 percent lidocaine and 1:100,000 epinephrine before undergoing dental procedures. The authors then randomized subjects to receive a PM injection or a control injection (sham injection in which a needle does not penetrate the tissue) in the same sites as the local anesthetic was administered in a 1:1 cartridge ratio after the procedure was completed.

Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults.

Background: The authors conducted two multicenter, randomized, double-blinded, controlled Phase III clinical trials to study the efficacy and safety of phentolamine mesylate (PM) in shortening the duration and burden of soft-tissue anesthesia. The study involved 484 subjects who received one of four commercially available local anesthetic solutions containing vasoconstrictors for restorative or scaling procedures.

Methods: On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection.