Regenerating and Restoring Organ Function Damaged by Disease or Trauma

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"We enjoyed the flexibility to develop software on multiple hardware targets and develop the same software across many solutions, which would not have been possible without NI technology and the CompactRIO platform. "

- Jeffery Bouchard, Biostage

The Challenge:
Creating a clinical-grade controller solution that meets changing needs in the development of bioengineered organ implants for life-threatening conditions.

The Solution:
Using LabVIEW software, CompactRIO hardware, and NI Requirements Gateway software to develop controller solutions that deliver the complex and precise functionality required in the regeneration of organs, the traceability required by the medical regulatory bodies, and the flexibility to support a continuous development process from proof of concept to clinical trial.

Author(s):
Jeffery Bouchard - Biostage

Biostage Cellframe™ Technology Enables the First Truly Personalized Approach to Organ Regeneration

Biostage (formerly Harvard Apparatus Regenerative Technologies [HART], a spin off from Harvard BioScience) developed the groundbreaking Cellframe™ technology that can unleash the body’s natural healing process and signal pathways to regenerate and restore organ function. Biostage has been active in regenerative medicine since 2010 and its Cellframe™ technology is based on more than 20 years of scientific progress in the fields of tissue engineering and cell biology.

Figure 1. Biostage Organ Implant Process

Precision and Flexibility Through LabVIEW and the CompactRIO Platform

Figure 2. Biostage Controller Block Diagram

The Biostage controller solution to grow large organs started in the spring of 2012. We have gone through several iterations, as can be expected in a rapidly evolving first-to-market product development situation. This evolution spanned the development of a proof of concept, iterations for researchers to learn and improve the product, and finally to the current clinical solution. We expect to continue advancing as regenerative medicine evolves. To support this journey, we changed our controller from one based on an Ethernet CompactRIO chassis to a CompactRIO controller to a Single-Board RIO controller. We also transitioned from an sbRIO-9626 device to an sbRIO-9606 device to an sbRIO-9607 controller over the course of development. In 2015, first as a beta tester, and then with its release at NIWeek 2015, we standardized on the sbRIO-9627 controller featuring the NI Linux Real-Time OS.  As we added new features to our system, we could smoothly transition to different controllers in the CompactRIO platform to meet our changing needs.

We enjoyed the flexibility to develop software on multiple hardware targets and develop the same software across many solutions, which would not have been possible without NI technology and the CompactRIO platform. We used all the cumulative development since 2012, even as we moved from a CompactRIO chassis to Single-Board RIO. We could focus on developing our solution instead of focusing on the development platform. Biostage has another solution based on a controller that is not built on NI technology. This solution has quickly become dated since any modifications require a major revamp and very few libraries can be transferred to a different controller.

Another benefit was that the Biostage controller required many system-level functions such as FTP, SQL, email, and remote access, among others. All these features are part of LabVIEW, which led to an efficient development process for us since we could use these in-built functions instead of developing them from scratch.

Figure 3. Biostage Bioreactor System Block Diagram

The CompactRIO platform FPGA is a key component of our solution. Biostage uses the power of the FPGA to add redundant and time-sensitive controls to our solution. We view the FPGA as a reliable hardware solution because it is a burned layer, software-derived solution. Once the configuration of the bioreactor is pushed to the FPGA, it manages the direct interaction with the bioreactor independently. The FPGA also provides life support by monitoring the real-time application and can reboot in case of a rare failure. The increased size of the FPGA in the sbRIO-9627 has helped us add features to future proof our solution.

One clinical controller can support four bioreactors. The bioreactor bus is a proprietary network that supports many forms of regenerative medicine bioreactors. The controller accurately controls the rotation and position of an organ implant. It controls and monitors the perfusion process (pressure, media types, temperature, pH, and more). The controller also monitors environmental conditions such as temperature, humidity, and gas levels, and the condition of cell culture media during the incubation phase as well as the imaging of progress of organ development. It has fully utilized the RIO Mezzanine Card (RMC) design with a custom daughter card and has allocated every I/O available in the sbRIO-9627 to deliver a versatile regenerative medicine control platform.

Regenerative medicine is a new field with rapidly advancing technology. We must continuously develop and grow our solution. NI’s hardware and software evolves to stay ahead of the technology curve, and we can migrate our solutions to the company’s newer technology easily. With NI we have found a partner that has supported our progression from proof of concept to the final solution.

Details on Biostage Bioengineered Organ Implant Solution

Biostage Cellframe™ technology enables the first truly personalized approach to organ regeneration and employs a multistep process in which the patient’s own cells are taken from a simple biopsy, expanded and banked, and finally seeded onto a proprietary scaffold that mimics the organ being regenerated. Cellframe™ technology delivers all the necessary cues for triggering, guiding, and modulating the regenerative process. After several days in a rotating bioreactor, the regenerated organ implant is ready to be implanted.

Esophageal, bronchial, and tracheal cancers and trachea trauma have a devastating impact on patients. Unfortunately, the current treatment options are complex and include surgical procedures like repositioning an intestinal segment in the chest to become replacement esophagi or removing a lung. These procedures carry serious risks of organ dysfunction and damage, leading to high complication rates and a drastically reduced quality of life.

Biostage offers a radically new way to treat these life-threatening conditions, potentially improving mortality rates, reducing complications, and enhancing patient quality of life. Our first generation trachea implants showed proof of concept in five patients. We completely re-engineered the current platform to better stimulate the regenerative properties of each of these organs. Cellspan implants provide a unique microenvironment that includes all the factors needed to induce tissue formation: physical structures, chemical composition, surface properties, and, perhaps most importantly, bio signals that direct cell behaviors. Our proprietary Cellframe™ technology plays a pivotal role in the success of in situ tissue regeneration by delivering three-dimensional support for cell growth and tissue formation. Essentially, we provide instructive cues to cells and stimulate target cell responses in the process of tissue regeneration.

Figure 4. Biostage Solution Overview

Author Information:
Jeffery Bouchard
Biostage
84 October Hill Rd.
Holliston, MA 01746
United States
Tel: (774) 233-7329
jbouchard@Biostage.com

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