Stem Cell Formulation for Superficial Ocular Pathologies

Case Studies >>

“Research Innovation to Clinic” Support for Stem Cell Formulation for Superficial Ocular Pathologies

A premier ophthalmic Institute in India has invented an innovative allogeneic stem cell formulation intended for treating superficial corneal pathologies. The Institute sought Nextvel’s support for the clinical development of this promising therapy and for obtaining the regulatory clearances. There were two stem cell formulations finalised by the Institute.

Nextvel was initially associated with helping in the validation and ensuring the regulatory compliance of the Institute’s cGMP (good Manufacturing Practice) facility and support in obtaining the necessary manufacturing licenses. Subsequently, Nextvel, provided support in obtaining regulatory approvals for conducting the clinical trials. Nextvel has offered regulatory compliance and project management oversight support for the clinical trials and assisted in post-approval regulatory compliance data management oversight and report writing.

Given the sensitive nature of stem cell products, the clinical trial required close management and monitoring. Nextvel utilized the latest Regulatory Compliant EDC Solution for data management, ensuring efficient and accurate data collection while maintaining the highest levels of data integrity.

Enrolment for the study was completed within the stipulated time frame, and the study itself was concluded within the given budget and timeline. The successful completion of this study has positioned the Institute at the forefront of stem cell research in India, with the potential to revolutionize the treatment of superficial corneal pathologies and alleviate the suffering of numerous patients.