Clinical Research

Progenitor Cell Therapy’s capabilities enable investigators and developers to focus on high-value work while PCT assumes responsibility for cell production, regulatory design/compliance, quality control, and distribution.

In addition to having access to a large patient population base and a wide range of cell therapy clinical protocols, we also have extensive experience in designing and implementing cell therapy clinical protocols.

Our cGMP/cGTP facilities meet stringent regulatory requirements and are able to deliver large volumes of standardized, high quality, engineered cells for clinical trials.

Phase I & II
Leveraging our manufacturing expertise, we complement the scientific protocol. FDA requirements and guidances are constantly being updated and continue to require an increasing level of compliance at earlier time points of product development. PCT can assist investigators in meeting these current challenges in a cost-effective manner, thereby eliminating the investigators' requirement to create a product research/development infrastructure.

Phase III Pivotal Trials 
The value that PCT brings to Phase I/II research is applicable in Phase III, where more stringent regulatory requirements apply. In addition, we facilitate the accrual of large numbers of patients though the use of our network of hospitals and physician practices, while ensuring that the manufacturing process and product testing are being consistently performed to the highest regulatory and quality standards. We ensure that Phase III trials are performed in a manner that is consistent with the goal of a commercialized therapeutic by maximizing the effectiveness of trial design, processes, and product development in early patient-based safety and feasibility trials.