Regenerative Medicine

In partnership with the US Army Medical Research & Materiel Command (USAMRMC), the Medical Technology Enterprise Consortium (MTEC) is pleased to announce the selectees in the initial round of research project awards issued under its February 29, 2016 Regenerative Medicine Request for Project Proposals. The projects listed at the bottom of this page were selected by the USAMRMC to receive funding as indicated.

The project teams funded through these awards will focus their activities on support areas of regenerative medicine manufacturing and prototyping that require development and harmonization into reproducible, consistent procedures which could stand the test of FDA approval. This emerging area of medical technology and innovation suffers from the lack of standard manufacturing procedures that support a combination product line. Outcomes from the activities conducted under these awards are anticipated to result in well-defined and sufficiently advanced prototypes and manufacturing procedures that may be included in regulatory applications for regenerative medicine products seeking FDA approval.

The research project award recipients were selected from the Offerors who responded to MTEC’s Regenerative Medicine Request for Project Proposals (16-01-REGEN). This solicitation invited proposals in five categories identified by USAMRMC as potential areas of improvement within the regenerative medicine domain.

These areas included:

  • Development of universal, defined culture media for regenerative medicine;
  • Bioreactors to enable efficient and cost-effective cell and tissue expansion for regenerative medicine products;
  • Cell, tissue and product preservation for regenerative and personalized medicine;
  • Large scale manufacturing and quality control of regenerative medicine – based products; and
  • Dynamic and innovative quality control for regenerative medicine manufacturing.

Commercial Scale Up of Bone Marrow-Derived Mesenchymal Stem Cells for Regenerative Medicine

Project Team: BioBridge Global; Rooster Bio, Inc.; StemBioSys; US Army Institute for Surgical Research
Award Amount: $8,079,619
Project Duration: 36 Months
Project Objective: The technology area being investigated is the development of large scale manufacturing and quality control of Regenerative Medicine – based products. The specific goal of this project is to make adult human mesenchymal stem cells manufactured without the use of animal products (i.e. “xeno-free” stem cells) widely available. This will be accomplished by leveraging the partners’ complementary technologies and processes, and adapting, optimizing and validating them for use in xeno-free microcarrier-based bioreactors of increasing capacity (500 mL → 3-5 Liters → 40-80 Liters).  These efforts will yield manufacturing technologies capable of producing commercial-scale, Current Good Manufacturing Practices (cGMP)-compliant stem cells. These cells will benefit both military and civilian regenerative medicine applications by accelerating clinical translation of cell therapies and tissue engineering technologies.

Year One Accomplishments:

  • Commercialized RoosterReplenish™-MSC-XF, a xeno-free human stem cell growth media booster.
  • Optimized 500mL microcarrier bioreactor culture conditions, achieving 200% of stem cell growth efficiency goal – ahead of schedule (400K cells/mL vs. 200K/mL goal).
  • Developed and validated a unique media additive that significantly increases stem cell potency.
  • Established clinical-grade manufacturing processes for making human platelet lysate products from 3 different sources of human platelets.
  • Developed prototype safety and potency assays – to potentiate future clinical use of stem cells.
  • Successfully initiated scale-up of the bioreactor process to 3L – ahead of schedule.
  • Optimization of cell growth and cell harvesting processes ongoing.

Manufacture of a Settable Nanocrystalline Hydroxyapatite/Polymer Composite Bone Graft

Project Team: Vanderbilt University; Medtronic
Award Amount: $1,095,160 (does not include proposed cost share of $689,010)
Project Duration: 36 Months
Project Objective: The technology area being investigated is the development of an injectable, settable bone void filler. Proposed activities will support development of a Current Good Manufacturing Practices manufacturing process, validation of stability-indicating analytical methods, and defining animal studies for upcoming regulatory submission to the U.S. Food and Drug Administration (FDA).

Year One Accomplishments:

  • Developed commercial-scale manufacturing processes for raw materials
  • Manufactured kilogram quantities of raw materials
  • Identified preliminary packaging configurations for future testing
  • Demonstrated graft remodeling and new bone formation in a preclinical model of bone regeneration


Development of Universal Media for the Support and Expansion of Human Cells for Regenerative Medicine Manufacturing

Project Team: RegenMed Development Organization
Award Amount: $5,000,000 (does not include proposed cost share of $5,200,000)
Project Duration: 60 Months
Project Objective: The overall objective of this project is to develop a well-defined xeno-free basal medium that supports the growth and viability of human cells derived from each of the three germ layers, and that can be used in conjunction with three specific supplements, each of which has been optimized to support the expansion of cells derived from one of the three germ layers. These germ layer-specific formulations will then be augmented with additional factors tailored to support the growth and function of several specific human cell types commonly employed in regenerative medicine. Since all formulations will be derived from the same “universal” basal medium, review by domestic and regulatory agencies will be greatly simplified and manufacturing costs will be substantially lowered.

Development of a Universal Bioink with Tunable Mechanical Properties for Regenerative Medicine Additive Manufacturing of Clinical Products

Project Team: RegenMed Development Organization
Award Amount: $5,000,000 (does not include proposed cost share of $5,200,000)
Project Duration: 60 Months
Project Objective: The overall objective of this project is to formulate a base bioink with a modular cocktail of cross-linkers that can be used to tune the mechanical properties of the hydrogel, both for bioprinting, and for adjusting the final stiffness of the bioprinted construct to match the stiffness of native tissues, ensuring optimal cell survival and tissue construct function. A series of bioprinting experiments will be conducted using several representative human cell types, with various bioink formulations and across a range of printing resolutions, to confirm that the greatest bioprinting speed is attainable while maintaining construct ultrastructure, cell viability, and function. A library of formulations using the standardized components will then be generated to provide reference points for fine tuning bioinks for additional applications. The development of this almost infinitely tunable bioink formulation will make it possible to achieve cost efficient manufacturing of a wide range of bioprinted regenerative medicine products.