Clinical Trials
4RMED
A new company, 4RMED LLC , was formed to direct and manage clinical trials and regulatory needs for INCELL and its clients. This will include designing and writing human subjects research protocols, managing new Investigational New Drug Applications (INDs) for drugs and biological products, and preparing the documents and support for medical device and combination products applications. Support will be provided for the content of the “CMC” (Chemistry Manufacturing and Control) sections. INCELL will continue as the GMP products manufacturer and contract services provider. INCELL technology use in the manufactured products is represented by the INCELL Inside™ trademark tagline.
Regenerative Medicine Products:
Clinical Studies and Trials in Development to Use the Following Tissue and Cell Products
- Perinatal tissue products
- Amniotic fluid tissue products
- Adipose tissue products
- Autologous adipose tissue-derived stromal vascular fraction cells
- Cell-enriched fat grafting: autologous; allogeneic
- Adipose-derived mesenchymal stem/stromal cells (Ad-MSCs): culture-expanded
- Microvascular tissue products
- Tissue and cell scaffolds
- Anti-inflammatory cells and exosomes
- Liver-derived cell products
- Tools, reagents, kits, media
Targeted Areas
INCELL’s on-going work and collaborations are multi-disciplinary and targeted to many areas of medicine. Most of the work on INCELL-owned clinical products is in the development or discovery phases, but INCELL is a contract manufacturer and developing many products for its clients.
Designated unmet medical needs are being pursued for trauma, non-healing wounds, orthopedic and surgical repair, inflammation, cancer, pain, orphan diseases and chronic disease.
Microbiology and Vaccines:
Clinical Studies and Trials in Development
- Acute pneumonia
- New anti-microbials vs. drug-resistant bacteria
- Enterocolitis
- Infected wound healing formulations
- New diagnostics
- Vaccines
- Tools, reagents, antibodies