Cytomatrix

212 West Cummings Park
Woburn, MA 01801

Phone: 781-939-0995

Unique Biomaterial for Long-Term Culturing
of Hematopoietic Stem Cells In Vitro
National Science Foundation, Phase IIB SBIR

Through the company's NSF Phase I and II SBIR work, Cytomatrix has developed a novel three-dimensional culture matrix termed Cellfoam that enables the long-term survival and multipotency of primitive HPCs in the absence of exogenous cytokines and enhances the ability to transduce HPCs with gene-carrying vectors at high efficiency.  Phase II has capitalized on these abilities toward two commercial clinical endpoints: 1) expansion of multipotent HPCs for stem cell transplantation and 2) genetic transduction of HPCs for purposes of gene therapy.  We have met and exceeded all of its Phase I and II objectives and achieved the following:

1) Pre-clinical optimization of a moderate-scale Cellfoam-HPC culture systems supporting a 3-5 fold expansion of HPCs under serum-free, cytokine-free condition.

2) Demonstration in a SCID mouse animal model of superior in vivo engraftment capabilities of HPCs cultured in Cellfoam systems compared to the gold standard, cryopreservation, and

3)Optimization of transduction and in vivo engraftment of HPCs transduced in Cellfoam.

To our knowledge, these capabilities are unique. In positioning the system for commercialization, we have extended the scope of Phase II to include several tangible business milestones as well, including:

  • Development of the baseline culture device into a clinical prototype system,
  • Manufacturing and assembly of the clinical system,
  • Development and licensing of a clinical serum-free, cytokine-free stem cell medium,
  • Submission of an FDA device master file, and
  • Drafting and submission of clinical trials protocols through investigator INDs being coordinated through multiple academic collaborators.