HINCKLEY, Ohio, Dec. 15, 2014 /PRNewswire/ -- Clinical Research Management, Inc. (ClinicalRM) today announced that the clinical trial evaluating the safety and efficacy of Ebola convalescent plasma (ECP) for the treatment of Ebola virus disease (EVD) in Liberia has commenced. The first donor survivors at the ELWA Hospital 2 unit in Monrovia, Liberia have undergone plasmapheresis. The donated convalescent plasma was transferred to a Liberian patient with EVD in an effort to help them combat this disease. The ClinicalRM trial is being funded through a grant from the Bill & Melinda Gates Foundation.
This clinical trial will involve EVD survivors at the ELWA Hospital, founded in 1965 by SIM, an international Christian organization, in Monrovia, Liberia. It will assess the efficacy of ECP to improve survival in patients with EVD. The primary objective of the trial will be to evaluate the safety and efficacy of ECP treatment. The donors who survived EVD have special factors in their blood that allow them to fight the disease. It is believed that these factors, also known as anti-Ebola antibodies, can be transferred to someone with EVD to help them fight the disease.
"We are pleased to have been able to begin the study and will now start to learn, within the context of a closely monitored clinical study, the therapeutic potential that ECP has on patients suffering from this life-threatening disease," said Dr. Jerry Brown, head of the ELWA 2 unit in Monrovia, Liberia and lead for the clinical trial. "Most critically, we will now have the human and technical infrastructure to combat Ebola and other diseases in the future." Dr. Brown was highlighted in TIME Magazine's Person of the Year 2014 "The Ebola Fighters" as one of the leaders fighting the epidemic.
"At a time when there is no specific therapy for Ebola, this trial is truly unique in that it serves to empower survivors of EVD with the ability to fight back through the donation of plasma that could potentially save someone's life," said William A. Fischer II, MD, Assistant Professor of Medicine, Division of Pulmonary and Critical Care Medicine, the University of North Carolina School of Medicine.
"As part of the trial, we have been able to enhance a range of lab capabilities within the hospital system allowing for real time electrolyte analysis," said David Wohl, MD, Associate Professor of Medicine, Division of Infectious Diseases, the University of North Carolina School of Medicine. "Monitoring and responding to electrolyte abnormalities is a huge benefit in the effort to care for and support people battling Ebola and it greatly enhances the healthcare team's ability to make informed and rapid treatment decisions." Drs. Fischer and Wohl, joined by faculty from Duke University, are situated in Liberia to assist in the clinical trial.
"A number of Liberian health care workers have been trained to conduct plasmapheresis and how to implement proper research techniques," said David Hoover, MD, Ebola Program Director, ClinicalRM. "This will empower local health care systems to become more self sufficient and better serve their patients during this current epidemic as well as in the future."
The survivors will have been tested to ensure that they are cured of EVD and are not infected with other diseases such as HIV-1, HIV-2, hepatitis B, hepatitis C and syphilis. For added safety, the trial's use of pathogen inactivation technology will substantially reduce the risk of any transfusion-transmitted infection from blood components.
"Launching this trial in this timeframe required incredible commitment and passion from everyone involved. Dr. Brown's dedication inspired all of us to move forward even when things seemed insurmountable," said Vicki Tifft, CEO and founder of ClinicalRM. "This is truly a global effort and there are many partners involved."
In addition to Liberia, the Bill & Melinda Gates Foundation support has provided for the establishment of plasma donation centers at Hopital National Donka (Conakry, Guinea) and Yaba Mainland Hospital (Lagos, Nigeria). It includes the research, scientific and technical involvement and expertise of academic, foundation and private sector partners. The convalescent plasma will be collected through mobile donation units fully equipped with Haemonetics PCS®2 plasma collection systems and the Cerus INTERCEPT™ pathogen inactivation blood system. Partners that traveled to support the trial on the ground in Liberia include Safe Blood for Africa and Blood Centers of America. The donor, manufacturing, testing and transfusion information management system is being provided by Blood Bank Computer Systems, Inc. (BBCS).
Founded in 1994, ClinicalRM is a full-service CRO with headquarters in Ohio and specializes in preclinical through Phase IV support of clinical trial services for biologics, drugs, and devices. Through international partnerships and a global selection of sites, they support their customers with a wide array of research, regulatory, and sponsor services that are tailored to accommodate clinical trials globally. Spanning the government, academic, and commercial marketplaces, ClinicalRM's multi-therapeutic team consists of leading experts in the fields of Infectious Disease, Vaccine Development, and Neurotherapeutics. ClinicalRM's goal is simple—to assist in improving the quality of life in communities throughout the world by advancing the goals of their customers.
The INTERCEPT Blood System is a trademark of Cerus Corporation.
PCS2 is a registered trademark of Haemonetics Corporation.
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SOURCE Clinical Research Management, Inc.