BHI Stem Cells Regulatory Compliance
Hundreds of allogeneic stem cell therapies are underway in humans for a wide-range of medical conditions. However, these studies are not always following regulatory compliances; accordingly they have not been proven to be safe. BHI Stem Cells has unique advantages over its competitors. We are in regulatory compliance in each country we conduct clinical trials to ensure the lab and clinical procedures are lawfully approved by their federal agencies. Based on our nonclinical and pilot clinical study results, showing the safety of our hUCB product, we are planning to start IND clinical trials.
FDA endorsed our Investigator-led IND (Investigational New Drug) application to allow for initiation of a clinical study of an FDA-approved cell therapy (HCP, cord blood) for treatment of acute ischemic stroke. This prospective, open-label, single-center, exploratory clinical study is designed to characterize the safety and efficacy profile of HCP, cord blood, when administered by intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke. Intravenous infusion of HCP, cord blood, in conjunction with mannitol, will be used in instances where a subject is unable to tolerate intrathecal administration.
In specific markets around the world, there is both the unmet need and the financial opportunity to establish medical facilities that provide the same quality as that found in the best facilities in the United States. BHI Stem Cells believes it is uniquely positioned to become a leader in providing the highest quality cellular therapies through centers it intends to locate throughout the world. BHI Stem Cells has recruited top medical professionals and scientific advisors, and regulatory specialists to help determine the best possible procedures to offer, to provide the appropriate protocols to monitor safety and efficacy, to collect and analyze outcome data for potential submission to the FDA and EMA, and to innovate patent procedures, devices, and therapies for future commercialization.