Stemedica International
Stemedica Cell Technologies, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing progenitor cell and protein therapeutics for underserved medical conditions. They utilize proprietary manufacturing technology to produce allogeneic progenitor cell products, with lead candidates including ischemia-tolerant mesenchymal stem cells and neural progenitor cells, currently in clinical development for conditions such as ischemic stroke, Alzheimer’s disease, and spinal cord injury. The company emphasizes innovative research, clinical trials, and strategic collaborations to advance regenerative medicine and stem cell therapies.
Industries
Stemedica International
Products
Ischemia-tolerant allogeneic mesenchymal progenitor cell therapeutic (intravenous)
Allogeneic mesenchymal progenitor cell product manufactured under ischemia-tolerant/hypoxic conditions and formulated for systemic (intravenous) administration in clinical studies for ischemic and neurodegenerative indications.
Ischemia-tolerant allogeneic neural progenitor cell therapeutic
Allogeneic neural progenitor cell product developed under ischemia-tolerant conditions for potential treatment of spinal cord injury and related indications.
Preserved allogeneic stem cell products
Preserved (storage-stable) allogeneic progenitor cell preparations intended for clinical use and distribution.
Cell-derived biologics (growth factors and exosomes)
Physiologically balanced growth factor preparations and exosome/secretome products derived from progenitor cell cultures, developed for therapeutic or research use.
Biodegradable microneedle delivery device
A patented biodegradable microneedle device intended to deliver proteins and large molecules into the dermis.
Ischemia-tolerant allogeneic mesenchymal progenitor cell therapeutic (intravenous)
Allogeneic mesenchymal progenitor cell product manufactured under ischemia-tolerant/hypoxic conditions and formulated for systemic (intravenous) administration in clinical studies for ischemic and neurodegenerative indications.
Ischemia-tolerant allogeneic neural progenitor cell therapeutic
Allogeneic neural progenitor cell product developed under ischemia-tolerant conditions for potential treatment of spinal cord injury and related indications.
Preserved allogeneic stem cell products
Preserved (storage-stable) allogeneic progenitor cell preparations intended for clinical use and distribution.
Cell-derived biologics (growth factors and exosomes)
Physiologically balanced growth factor preparations and exosome/secretome products derived from progenitor cell cultures, developed for therapeutic or research use.
Biodegradable microneedle delivery device
A patented biodegradable microneedle device intended to deliver proteins and large molecules into the dermis.
Services
Clinical-grade cell manufacturing (cGMP)
On-site production of clinical-grade allogeneic progenitor cell products under cGMP conditions to support clinical trials and scaled production.
Clinical trial sponsorship and program management
Sponsorship and operational management of Phase I through Phase III clinical trials for progenitor cell therapies, including randomized double-blind multicenter studies.
Clinical-grade cell manufacturing (cGMP)
On-site production of clinical-grade allogeneic progenitor cell products under cGMP conditions to support clinical trials and scaled production.
Clinical trial sponsorship and program management
Sponsorship and operational management of Phase I through Phase III clinical trials for progenitor cell therapies, including randomized double-blind multicenter studies.
Expertise Areas
- Cell therapy development
- cGMP manufacturing and scale-up for biologics
- Regulatory submissions and FDA IND processes
- Clinical trial management for neurological and ischemic indications
Key Technologies
- cGMP cell manufacturing
- Ischemia-tolerant (hypoxic) cell conditioning
- Allogeneic mesenchymal progenitor cell therapies
- Allogeneic neural progenitor cell therapies