Ottawa Researchers Conduct First Clinical Trial Using Stem Cell Therapy to Treat Septic Shock | Mesenchymal Stem Cell Therapy Supplies | Corning

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Researchers from the Ottawa Hospital Research Institute successfully take their innovative research to the next level—scaling up to prepare for large-scale clinical research that may reframe the approach to treating patients with septic shock.

Introduction

Research using the production of mesenchymal stem cells (MSCs) is expanding—leading to clinically relevant discoveries across therapeutic areas. Led by Dr. David Courtman, Director Biotherapeutics, the Ottawa Hospital Research Institute’s Cell Manufacturing Facility successfully conducted a Phase I clinical trial examining the safety and efficacy of allogeneic bone marrow-derived MSCs as a treatment for patients experiencing septic shock.

In their Phase I trial, freshly cultured allogeneic bone marrow-derived MSCs were dosed into patients with septic shock.1 A single dose was manufactured using the Corning® HYPERFlask® on an as-needed basis. Since dosing was developed on an emergent per-patient basis, researchers were notified of a patient enrollment and had to deliver the dose within 6 hours.

The Challenge? Large-Scale Production of MSCs in a Space-restricted Facility

Larger-phase clinical trials were needed to determine true clinical impact and this required a significant scale-up of MSCs. That is what Courtman and his colleagues tackled next.

Before initiating clinical Phase II studies, the protocol for generating large quantities of MSCs had to be established to reduce end-product variability, minimize production costs, and to ensure sufficient yield to treat multiple patients. Maximizing the yield of viable cells proved challenging in a limited footprint.

“Hospital-based cell manufacturing facilities often have significant space and staffing constraints making the more standard scale up process difficult to accomplish. The Corning HYPERStack system provides a much more manageable platform to reach batch production levels appropriate for the typical scale up required in academic trials with MSCs.”
 

—Dr. David Courtman
Director Biotherapeutics

Perfecting the Protocol with Customized Support from Corning

For the Phase I trial, the cell manufacturing lab utilized the Corning HYPERFlask to grow and reproduce allogeneic bone marrow-derived MSCs. To take the research to the next level, researchers needed to be able to work within the same isolator units, following the same protocol, with successful, reproducible cell culture on a much larger scale. “We were aware of the Corning® HYPERStack® and needed to make the most of our limited footprint while scaling up and maintaining successful cell harvest. The Corning HYPERStack seemed like the logical next step,” says Saad Khan, Senior Research Associate in the Cell Manufacturing Facility and lead researcher in the scale-up study.

“We were aware of Corning HYPERStack and needed to utilize the same footprint while scaling up and maintaining successful cell harvest. The Corning HYPERStack seemed like the logical next step.”
 

- Saad Khan
Senior Research Associate

Using the Corning HYPERStack cell culture vessels, Khan and colleagues successfully scaled up the production of bone marrow-derived MSCs while maintaining cellular characteristics such as identity and potency.2

Says Courtman, “We were concerned about the challenge of getting the cells out.” Michael Bagguley, Bioprocess Specialist, stepped in to quickly assist the lab in creating a customized strategy for scale-up. “Michael was extra helpful in providing consultation on manipulating the cells in the vessel, cell seeding, media changes, and harvesting—all within the isolator units. He was there to offer suggestions and expertise along the way,” adds Courtman.

Potential Significant Impact on Patients’ Lives

For the cell manufacturing team, the end goal is to develop a safe, potent, and effective cell therapy product. “If successful, this could have a significant impact on the course of disease for patients,” says Courtman.

Learn more about this research and other innovative discoveries taking place at the Ottawa Hospital Research Institute by visiting http://www.ohri.ca/home.asp

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References

1. McIntyre LA, Stewart DJ, Mei SH, et al. Cellular immunotherapy for septic shock. A phase I clinical trial. Am J Respir Crit Care Med. 2018;197(3):337-347.

2. Khan S, Davila L, Salkhordeh M, et al. cGMP-compatible large-scale production of mesenchymal stem cells (MSCs) in xeno- and serum-free media for allogeneic cell therapies. Ottawa Hospital Research Institute. Ottawa, ON, Canada.

Warranty/Disclaimer: Unless otherwise specified, all products are for research use only. Not intended for use in diagnostic or therapeutic procedures. Corning Life Sciences makes no claims regarding the performance of these products for clinical or diagnostic applications.