Clinical Stem Cell Services

Developing cellular therapies requires strict adherence to manufacturing and regulatory standards that are different for each national regulatory agency. REPROCELL can help you through all stages of your regenerative medicine project.

Cell-based therapies have significant potential to provide patient relief in a broad range of disease areas, from cancer to degenerative disorders. Many of these projects start with iPSCs (induced pluripotent stem cells) or with MSCs (mesenchymal stem cells). Master cell banks (MCBs) can be effectively generated from these stem cells, ensuring product consistency while managing risk by eliminating contamination and genetic instability.

Our clinical stem cell services:

Specifically, iPSCs are straightforward to manipulate genetically, and the modified iPSCs open the path for innovative therapeutics. Some examples include gene correction for the therapeutic rescue of genetic diseases, the addition of genes at precise genome sites, and the creation of hypoimmune lines that can overcome HLA mismatches.

Whether your project starts with iPSCs or MSCs as the source for your stem cell-based therapeutic project, or if you are interested in clinical gene editing, REPROCELL can assist you!

REPROCELL is a global company that serves customers all around the world. Our worldwide presence ensures that our client's cell therapy projects are compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA. We will provide the necessary quality and regulatory documents including donor eligibility, CoAs, batch records, traceability documentation, and quality technical agreements for your GMP Master Cell Bank or Cell Therapy product.

Review article (offsite)

How to find the right end-to-end developer for manufacturing your cGMP-compatible iPSCs

From β-islets for diabetes to dopaminergic neurons for Parkinson’s disease, induced pluripotent stem cell (iPSC)-derived, haplotyped, and multiplex-engineered allogeneic cell therapeutics empower the development of effective and safe Cell and Gene Therapy Products (CGTs) that could be manufactured on a large scale in a cost-effective manner and provide a functional cure for diseases that plague humankind today.

Bioinformant

Review article (offsite)

Making iPSC-derived therapies a clinical reality

Since their invention in 2006, induced pluripotent stem cells (iPSCs) have revolutionized how researchers approach disease modelling, drug discovery research, and drug development. Derived from adult somatic stem cells rather than embryos, iPSCs have allowed scientists to study human biology with increased depth, reproducibility, scalability, and translatability. This is especially true for diseases where animal models lack clinical relevance, and where primary tissues are difficult to access.

Stem Cell Research and Technology