Trial Profile
A Phase III pivotal trial of Mesenchymal stem cell therapy in both adults and children
Status:
Planning
Phase of Trial:
Phase III
Latest Information Update: 15 Mar 2023
Price :
$35
*
At a glance
- Drugs Mesenchymal-stem-cell-therapy NextCell-Pharma (Primary)
- Indications Type 1 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms ProTrans-3
- Sponsors NextCell Pharma
Most Recent Events
- 18 Jan 2023 According to a NextCell Pharma media release, the plan also includes preclinical studies of biodistribution and toxicology and the company is reviewing the recommendations by the PDCO and amending the proposal prior to submitting for approval.
- 18 Jan 2023 According to a NextCell Pharma media release, the company has received positive comments and recommendations for the pediatric investigational plan (PIP) submitted to the Europeans Medicines Agency's (EMA) pediatric committee (PDCO) that aiming to ensure that children younger than 7 years old can also receive treatment in the future. The changes do not affect the study design.
- 28 Sep 2022 According to a NextCell Pharma media release, a pediatric development plan (Pediatric Investigation Plan, PIP) is required for drug development for the treatment of children. The company has submitted an application, which will be considered by the European Medicines Agency's expert committee at the end of the year 2022. The application includes ProTrans-3, a pivotal phase III study for both adults and children that, if positive, can give ProTrans marketing approval.