Since OpenBiome — the first nonprofit public stool bank — launched in 2012, it has provided fecal microbiota transplantation preparations to treat more than 13,000 patients with recurrent Clostridium difficile infection.
CDI is the most common microbial cause of health care-associated infections in U.S. hospitals, affecting about 450,000 patients per year, of whom nearly 30,000 die within 30 days, according to recent statistics from the CDC. However, one in five patients with CDI do not respond to antibiotics.
Recently, FMT has emerged as a highly effective treatment for recurrent CDI, with 80% to 90% success rate, and thus, OpenBiome’s mission has been to provide safe access to FMT and catalyze microbiome research.
The team at OpenBiome welcomed Healio Gastroenterology to their facility in Somerville, Mass., just outside of Boston, where we had the opportunity to speak with Carolyn A. Edelstein, MPA, OpenBiome’s director of policy and communications, Zain Kassam, MD, MPH, FRCPC, OpenBiome’s chief medical officer, and co-founders James Burgess, and Mark Smith, PhD, who was recently named to Forbes ‘30 Under 30’ for Science.
“At this point, we work with over 800 medical facilities in the U.S. in all 50 states, and our last mapping assessment showed that close to 99% of the population is within a 4-hour drive of a provider, and about 97% are within a 2-hour drive of a provider,” Edelstein said.
This rapid expansion of OpenBiome has contributed to the organization’s ability to set the standard for safety in FMT, she explained.
“The scale we’ve achieved — having provided more than 20,000 treatments so far — allows us to be far more conservative than providers and patients could accomplish on their own. Between our screening process, which eliminates about 97% of candidates ... and our GMP [Good Manufacturing Processes] lab, we can bring a heightened level of rigor to the quality of the material.”
Despite the high success rate and rigorous safety protocols, several barriers to FMT access remain, all of which OpenBiome is working to address.
“At conferences, we hear about all kinds of barriers clinicians face when trying to bring an FMT program into their hospital, but at least patients are now within striking distance of an FMT provider,” Edelstein said.
One such barrier is that “the regulatory environment still contains some uncertainties,” she explained. “In May 2013, the FDA announced that FMT will be regulated like an investigational drug, so it would need to be performed in clinical trials registered with the agency. There was pushback at that announcement, with medical societies and practitioners arguing that it would be overly restrictive for patients with recurrent CDI, given available evidence on safety and efficacy. Clinical guidelines from gastroenterology and infectious disease societies in the U.S. and abroad have recommended FMT for patients who have failed two or more rounds of antibiotics. Two months later, the FDA issued the current prevailing guidance, which says that to treat CDI that’s not responsive to standard antibiotics, you can use FMT outside of a clinical trial framework as long as you obtain informed consent. Still, some sites struggle with whether or not to allow the investigational treatment without an IRB or without an [investigational new drug designation].”
Another barrier is variation in protocols, Edelstein said. “We are working on developing protocols for hospitals that they can adapt for their purposes. It can take a long time to build up a program, and we sit at the center of 800 medical facilities who have already solved these problems, so we’re consolidating best practices and we’ll be sharing a protocol soon.”