Preclinical Data | Biomerix 3D Scaffold™

Numerous studies conducted in collaboration with leading university-based researchers have demonstrated successful results with hematopoietic stem cell niches, adipose-derived mesenchymal stem cells, co-cultured cord blood and mesenchymal stem cells, induced pluripotent stem cells, and numerous other cell lines.

Study Highlights

A Novel Flow-Perfusion Bioreactor Supports 3D Dynamic Cell Culture

Stephen M. Warren, M.D., New York University Medical Center, NY

Murine preosteoblastic cells were seeded onto large Biomerix 3D Scaffold discs (24 x 6 mm) and loaded into a custom flow-perfusion bioreactor. Viable cellular density and metabolic activity were successfully demonstrated through eight days in-vitro.1

Result: The Biomerix 3D Scaffold may support prefabrication of biological constructs large enough to solve clinical problems.

Ectopic Human Mesenchymal Stem Cell-Coated Scaffolds in NOD/SCID Mice: An In Vivo Model of the Leukemia Niche

Sarah Vaiselbuh, M.D., The Feinstein Institute for Medical Research, NY

Human mesenchymal stem cells were seeded onto Biomerix 3D Scaffold constructs and implanted in NOD/SCID mice. Histological analysis at eight weeks showed that the scaffold successfully supported creation of an ectopic human bone marrow microenvironment. Implanted scaffolds were then inoculated with acute myeloid leukemia cells. Histological analysis at five months demonstrated that the in-vivo stromal microenvironment supported leukemic hematopoiesis. Finally, a known leukemia antagonist, AMD3100, was shown to disrupt formation of subcutaneous leukemic tumors.2

Result: The Biomerix 3D Scaffold provides an excellent platform to create in-vivo disease models that can be used for targeted drug discovery.

Use of the Biomerix 3D Scaffold to Enable Creation of a Bone Marrow Hematopoietic Niche

Daniel Kraft, M.D., Stanford University, CA

Murine bone marrow cells were isolated and suspended within Biomerix 3D Scaffold constructs and implanted into the renal capsule of GFP+ transgenic mice. Donor cells were tracked in-vivo for eight months. Biorix 3D Scaffold allowed transplanted hematopoietic stem cells to establish and expand, and formed an osteogenic niche from the fetal cells.

Results: The Biomerix 3D Scaffold is an excellent platform for bone marrow niche formation and expansion of hematopoetic stem cells.

Comparison of Biosynthetic Activity of Biomerix 3D Scaffold Vs. Engineered Biologic Scaffolds Using Murine Fibroblasts

Dr. Anuradha Subramanian, Ph.D., University of Nebraska, NE

Murine fibroblasts cells were seeded onto 4 different scaffolds: (A) freeze-dried chitosan, (B) Biomerix 3D Scaffold, (C) electrospun gelatin scaffolds, and (D) templated electrospun gelatin scaffolds.  Scaffolds harvested at 14 days and analyzed by SEMs, confocal microscopy, and assays.  The Biomerix 3D Scaffold demonstrated superior biosynthetic activity with maximum cell viability, greatest depth of cellular infiltration, and a preferential rounded cell morphology.

Result:  The Biomerix 3D Scaffold offers the potential to serve as a superior platform for a wide range of tissue engineering applications.

Culturing of Meniscal Fibrochondrocytes on Coated Biomerix 3D Scaffold Constructs

Daniel Grande, Ph.D., The Feinstein Institute for Medical Research, NY

Meniscal fibrochondrocytes were seeded onto Biomerix 3D Scaffold discs coated with either fibronectin or collagen gel and successfully maintained in static culture for up to 28 days. The scaffold supported deposition of ECM with high collagen content within the pore structure; meniscal cells retained their desired rounded morphology.

Result: The Biomerix 3D Scaffold supports fibrochondrocyte adhesion and proliferation and demonstrates potential as a scaffold for tissue engineering.

Culturing of Human Osteoblasts on Degradable Biomerix 3D Scaffold Constructs

Amit Bandyopadhyay, Ph.D., University of Washington, WA

Highly porous, degradable Biomerix 3D Scaffolds using degradable polycaprolactone were seeded with 1.5 x 105 human osteoblast cells and maintained in static culture for 7 days.  Scaffolds were harvested at Days 3 and 7 and analyzed via SEM analysis.  Scaffolds showed excellent bone cell attachment after 7 days in culture with good cell-cell interactions.

Result:  New degradable Biomerix 3D Scaffolds offer the potential to serve as a tissue scaffold for bone tissue engineering applications.

Creation of a Bioartificial Niche for the Expansion of Umbilical Cord Blood Stem Cells in a Rotating Bioreactor

Stephen Navran, Ph.D., Synthecon Inc., TX

Bone marrow stromal cells (MSC) were cultured on Biomerix 3D Scaffold discs in a rotary cell culture system (Synthecon, TX). Umbilical Cord Blood (UCB) cells introduced into the bioreactor homed to the stroma/scaffold niche and were maintained for two weeks.

Results: The Biomerix 3D Scaffold can create a bioartificial niche for the expansion of rare UCB stem cells.

Culturing of Human Adipose-Derived Stem Cells on Uncoated and Coated Biomerix 3D Scaffold Constructs

Peter Rubin, M.D., University of Pittsburgh, PA

Human adipose derived stem cells (ASCs) were seeded onto Biomerix 3D Scaffold discs both with and without fibronectin coating. Robust attachment of human ASCs was demonstrated on the Biomerix 3D Scaffold both with and without fibronectin coating for 72 hours in static culture.

Result: The Biomerix 3D Scaffold supports human ASC attachment and proliferation and demonstrates potential as a scaffold for tissue engineering.

1Sailon AM et. al. A novel flow-perfusion bioreactor supports 3D dynamic cell culture. J Biomed Biotechnol. 2009;2009;873816. Epub 2009 Dec 9.
2Vaiselbuh SR et. al. Ectopic Human Mesenchymal Stem Cell-Coated Scaffolds in NOD/SCID Mice: An In Vivo Model of the Leukemia Niche.Tissue Eng Part C Methods. Epub 2010 Jun 29.