Bioengineered Renal Cell Therapy Device for Clinical Translation

Area of Science:

• Biomedical Engineering
• Regenerative Medicine
• Nephrology

Background:

• Acute kidney injury (AKI) presents a significant clinical challenge.
• Cell-based therapies offer potential for AKI treatment but face manufacturing and distribution hurdles.
• Previous bioartificial renal epithelial cell systems (BRECS) were limited by slow, expensive computer numerical control (CNC) fabrication.

Purpose of the Study:

• To develop a mass-producible BRECS using injection molding (IM-BRECS).
• To reduce manufacturing costs and increase production speed while maintaining therapeutic function.
• To improve cryopreservation and thawing efficiency compared to previous designs.

Main Methods:

• Designed and produced injection-molded BRECS (IM-BRECS) prototypes.
• Evaluated IM-BRECS performance using stereolithography BRECS (SLA-BRECS) as an intermediate step.
• Assessed IM-BRECS for heat transfer, cryopreservation/thawing efficiency, and in vitro cell culture performance (metabolic activity, cell support).

Main Results:

• IM-BRECS significantly reduced cost (<$20/unit) and increased manufacturing speed (hundreds of units/h).
• The finalized IM-BRECS design featured a smaller fill volume (10 ml), mass (49 g), and footprint.
• IM-BRECS demonstrated superior heat transfer, improving cryopreservation cooling control and reducing thaw times.
• In vitro cell culture showed IM-BRECS maintained cell metabolic activity and support comparable to CNC-BRECS.

Conclusions:

• Injection molding enables cost-effective, high-volume production of BRECS.
• IM-BRECS offers improved thermal performance for cryopreservation and thawing.
• The IM-BRECS maintains essential cell therapy functions, paving the way for wider clinical application in AKI treatment.