Clinical Development

Lead Program

Lead indication: Ischemic stroke with persistent neurologic impairment.

Development status: CBER IND 33055 submitted to FDA through ESG NextGen / USP as eCTD sequence 0000. The package includes signed Form FDA 1571, initial IND materials, RMAT designation request, Type B meeting request, CMC/manufacturing readiness letter, and supporting Stemedica-originated clinical/regulatory background materials.

Pipeline Line

Program

SanoMSC

Modality

Allogeneic MSC cell therapy

Indication

Ischemic stroke with persistent neurologic impairment

Stage
FDA IND-submitted

Phase IIb/III-ready development positioning