Continuing Hope Through COVID
A tale of a Houston organization defying the odds
When the first case of the 2019 novel coronavirus was detected in the United States in January of 2021, no one could have anticipated how rapidly it would spread or how devastating its effects would be. By mid-February, COVID-19 was barreling toward pandemic status and on March 11, the WHO declared it as such. Everyone felt the impact. Americans were scrambling to gather enough food, medical supplies, and disinfecting agents to last through an indeterminate time of home quarantine. Grocery stores struggled to meet the high demand and desperate customers were met with empty shelves.
The Texas Governor, Greg Abbot, declared the new coronavirus a statewide public health disaster on March 13 and with that was the gut-wrenching realization that it was not going away any time soon. The number of COVID-19 infections and related deaths were rising each day, while schools, workplaces, churches, and restaurants began closing in an effort to stop the spread. As we witnessed businesses closing all around us, anxieties began to increase about whether our current clinical trials would have to be discontinued.
Our focus and energy were quickly put into implementing safety procedures that would protect our employees and patients and allow our business to remain operational. We were actively manufacturing stem cells for several clinical trials before the pandemic hit, and we refused to let down the patients that depend on us for their treatments. In the healthcare industry, hospitals were struggling to maintain adequate supply levels needed for operation and non-emergency services were discontinued, furthering an already severe financial strain. We knew we couldn’t save the world from this virus, but we believed in the science of our stem cells and we knew we could offer help to our local community.
Fortunately for us, there was something in the works before the pandemic hit that would prove vital to our 2020 clinical trial efforts. The Hope Biosciences Research Foundation (HBRF) was officially opened on March 5, with a mission to accelerate cell therapy development so treatments could be delivered faster. By mid-March that same year, the HBRF clinical research team was hard at work, drafting COVID-19 trial proposals for the FDA in record time. Waiting to hear back from the FDA was excruciating. The virus wasn’t going away, and the number of hospitalizations and deaths continued to climb. We knew we had to do something for at-risk members of our community as quickly as possible. Everyone’s hard work and patience paid off when on April 6, 2020, we received FDA approval for a Phase II clinical trial evaluating the safety and efficacy of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19. The goal was to pre-treat participants that were at a higher risk of developing severe COVID-19, with the belief that we could prepare their immune systems and give them their best chance to fight the virus.
While still celebrating the news of the first FDA approval, we received a second FDA clearance for a Phase II clinical trial studying Hope Biosciences’ allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs) for COVID-19. This one was aimed at frontline workers with the goal of building a line of defense for the most vulnerable in our population. Both studies, the open-label, autologous study and the allogeneic study ran in parallel. Analyzing the data from these parallel studies amplified their impact and allowed us to better understand the effectiveness of HB-adMSCs to protect against COVID-19.
By mid-April 2020, manufacturing for our COVID-19 trials was fully underway. We were operating at a level much higher than our small biotech start-up had ever experienced before. We were admittedly stressed, and, in all honesty, some days were a struggle. But this was our contribution, and it was undoubtedly a labor of love. While these small local studies may not have received the level of recognition given to the major pharmaceutical companies globally, the data we obtained can and will be used to demonstrate the regenerative and protective power of our body’s