The Potential of Our Investigational Human Acellular Vessels
Behind the rigor of our research methods, our scalable production process, and our well-planned clinical trials, we have a guiding goal: Lifesaving and long lasting vascular access or replacement for patients with End Stage Renal Disease. Our investigational human acellular vessels (HAVs) make this goal possible. Subject to future clinical trials and regulatory approval, our vessels have the potential to offer patients and vascular surgeons the opportunity for significant advances for vascular access:
- Demonstrate function in future clinical trials
Our approach follows the well-established clinical setting for products creating hemodialysis access for renal patients who need alternatives to fistulas and plastic grafts. Because this setting has proven safe and reliable for developing synthetic and biological vascular grafts, we can compare our investigational HAV patency and critical secondary measures (e.g. infection rates and need for surgical intervention) to standards of care in well-planned, robust clinical trials.
- Provide a mechanically-robust and innovative surgical option
Our investigational HAVs could fill a critical need for surgeons who require prosthetic vascular options which are easy to handle, implant, and maintain. We manufacture our HAVs in bioreactors which produce a dynamic, highly flexible, and robust vascular conduit. Subject to further development and regulatory approval, these biologic vascular vessels have the potential to eliminate invasive procedures like biopsy or harvesting of the patient’s own veins.
- Be readily available to patients at the time of surgical need
We want patients to receive the lifesaving vascular replacements they need as soon as possible. Our investigational HAVs have the potential to be refrigerated and stored on-site in hospital ORs, which could eliminate the complicated ship time, logistics, and storage associated with donor grafts. Once approved for use, our HAVs could drastically reduce patient, surgeon, and hospital wait times for vascular access and replacement surgeries.
- Reduce immune response
We derive our investigational HAVs from native human tissue, and then decellularize our vessels to yield only the human extracellular matrix. Our data indicates this process leaves no remaining cells to generate an immune response—reducing the risk of additional complications from vascular access or replacement surgery.
- Scale production for more economical results
Our modular manufacturing approach lets us produce investigational HAVs in parallel, allowing much faster production than the standard method of individually growing single grafts. Our process for producing investigational HAVs could yield a more efficient, economical, and scalable manufacturing design that saves time and lowers costs.
How We Produce Our Investigational HAVs
At Humacyte, we currently manufacture HAVs for investigational use through a unique bioreactor cell culture process followed by a multi-step decellularization process which (according to presently-available data) removes cellular components from the tissue-engineered vessel. We have also developed a scalable, functionally-closed manufacturing process using automation and plastic-based bioreactors.
Following further development and regulatory approval, our goal is to design and create a manufacturing process to produce commercial quantities of our investigational HAVs and conduit products in a scalable, cost-effective manner.
Our ongoing research and development activities include pilot scale operations in our current Humacyte cGMP manufacturing space as well as plans to transition to large scale campaign production. We have already produced Phase I and II clinical supplies in our current space, and anticipate continued evolution of our broader scaled system in 2016 and beyond.