Long-Lasting Vascular Access for Patients upon Dialysis Receives FDA Designation
One of the first RMAT (regenerative medicine advanced therapy) designations from the US Food and Drug Administration has been awarded in order to Humacyl, an investigational human acellular vessel (HAV). Carrie Cox, CEO and chairman of Humacyte, the company which makes Humacyl, said the designation is an honor and is the testament to the fact that Humacyl addresses an unmet medical require of patients with end-stage renal disease on dialysis.
The RMAT status will expedite the review process for HAVs plus make additional resources available to the developer of the treatment. Support in the form of advice, communication, and proactive involvement simply by senior staff at the FDA will result in a more collaborative work. The FDA designates its most experienced managers in order to RMAT projects.
RMAT has been unveiled in January after the 21st Century Cures Act has been passed. The designation indicates that the therapy is a cellular therapy, tissue engineering product, human cell product, or even a combination of these which modifies, reverses, treats, or remedies a life-threatening medical condition. In addition , the developer must show that the therapy can potentially address currently unmet needs associated with patients with a life-threatening disease.
Durable vascular access for patients with end-stage renal condition on dialysis can be a lifesaver, and Humacyl was developed using this goal in mind. Humacyte is testing the product in scientific trials to assess infection rates and need for medical intervention compared to fistulas and plastic grafts.
HAVs offer surgeons an easy-to-handle and easy-to-maintain prosthetic vascular option. HAVs are a powerful, robust, and highly flexible type of vascular access that could potentially eliminate the need for invasive procedures such as harvesting the particular patient’ s own veins and performing biopsies.
Importantly, Humacyl vascular substitutes are designed to be stored in refrigerators on-site in hospital ORs, hence eliminating the shipping times, handling, and storage strategies that donor grafts are subject to. It is expected that will, once approved, HAVs will drastically reduce waiting occasions for vascular access procedures.
One of the key advantages of investigational HAVs is that they are usually derived from native human tissue. The tissue-engineered vessels go through a multi-step decellularization process that removes cellular parts to yield the extracellular matrix. Because all tissue are removed, the HAV does not generate an immune system response, thus reducing the likelihood of complications from vascular entry placement.
Finally, investigational HAVs will be mass produced by parallel production rather than separately growing each graft. This method will make the product more economical. Scalable manufacturing is associated with not only lower costs, but also period savings.
1 . Humacyte Receives First of FDA’ s Regenerative Medicine Designations – See more at:
2 . Human Acellular Ships