Stem Cell Activator (SCA) Protein

1. Overview

Brief Description: Stem Cell Activator (SCA) is a novel, synthetic, codon‑optimized protein expressed from synthetic DNA designed specifically for mammalian cells. It acts as a potent stem cell activator that triggers multiple survival and stemness pathways, including PI3K, Erk, GSK3, Wnt signaling, and Yamanaka factors (Oct3/4, Sox2, Klf4, c‑Myc). By doing so, it promotes cell survival, sustains proliferation, and enhances or maintains stemness, with potential to generate adult stem cells in large quantities without viral vectors or permanent genetic manipulation.

Development Stage: The technology is at the TRL - 4 stage, experimentally validated in vitro with detailed sequence information, methods of production, and in vitro experimental validation (cell lines, primary mouse embryonic fibroblasts, reporter assays, iPSC reprogramming experiments). It has been demonstrated in cell culture and 3D tissue models.

2. Key Features

• Synthetic, Codon-Optimized Protein: Fully synthetic DNA construct for efficient expression in mammalian cells and E. coli, ensuring controlled and scalable production.
• Multi-Pathway Activation: Simultaneously activates PI3K, Erk, GSK3, Wnt signaling, and Yamanaka factors, promoting cell survival, proliferation, and stemness without multiple growth factors or viral transgenes.
• Built-In Variability and Customizable Variants: A variable region allows for tailored SCA variants for diverse applications and cell types, uniquely combining Wnt and Yamanaka activation for efficient, non-viral stemness induction.

3. Benefits:

• Economic Impact: Reduced production costs and simplified processes due to recombinant bacterial production of SCA, leading to lower cell therapy manufacturing expenses.
• Social Impact: Enhanced access to stem cell-based therapies, fostering regenerative medicine development, enabling safer reprogramming methods, and accelerating scientific discovery.
• Environmental Impact: Lower resource consumption (media, plastics, reagents) and potential for defined, xeno-reduced media systems due to SCA's fully synthetic design.

4. Applications:

• Regenerative Medicine and Cell Therapy
• Drug Discovery, Toxicology, and Research Tools

Research Opportunities:  

• In Vivo Proof‑of‑Concept: Evaluating safety, biodistribution, immunogenicity, and efficacy of SCA in animal models for tissue regeneration.
• Bioprocess & Formulation Development: Optimizing recombinant production, purification, stability, and formulation of SCA for scalable manufacturing.

5. Case Studies:

• Activation of Survival Pathways and Proliferation in Epithelial Cells and 3D Models: Demonstrates SCA's role as a general survival and proliferation enhancer that can support high‑density cell and tissue culture.
• Wnt Pathway Activation, Yamanaka Factor Induction, and Enhanced iPSC Generation in MEFs: Provides strong in vitro proof that SCA is a potent Wnt and Yamanaka activator, and a powerful enhancer of somatic cell reprogramming to iPSCs.

6. IP Status:

• Intellectual Property: Filed Indian patent vide application number 202341056900 dated 24 August, 2023.

7. Support Offered:

• Licensing Options:Exclusive or Non Exclusive Licenses for companies or institutions interested in therapeutic, diagnostic, or research tool development.
• Technical Support: Experimental protocols and optimization guidance and assistance in setting up SCA based assays or reprogramming workflows.
• Collaboration Opportunities: Co-development of therapeutic applications (e.g., combining SCA with specific stem cell types, scaffolds, or delivery systems), Research collaborations to explore new cell types, in vivo models, or variant optimization and Industry partnerships for scaling up recombinant production and moving toward regulatory development.

8. Contact Information:

Contact Person: Dr. Karthika Rajeeve, Scientist, BRIC-RGCB

Email Address: karaj@rgcb.res.in, techventures@rgcb.res.in

Phone Number: +91-471-2529-521