Clinical trials are research investigations that play an important role in the development of health information and research for public health care. Clinical trials guiding principles are based on maximum benefit and minimal risk to the participants enrolled in a study.
According to the Ethical Principles for Medical Research Involving Human Subjects (World Medical Association Declaration of Helsinki), “every clinical trial must be registered in a publicly accessible database before recruitment of first subject”. The main registry purpose is to fulfill ethical obligations to participants and the research community and provide information to potential participants and referring clinicians.
BHI Therapeutic Sciences (BHITS) announced the registration of the clinical trial entitled “Evaluation of the Safety and Efficacy of Hemacord HPC, Cord Blood in Subjects with Acute Ischemic Stroke” at the ClinicalTrials.gov registry of clinical trials. Initiation of the clinical study, presented in the Investigator-led IND (Investigational New Drug) application, was endorsed by The Food and Drug Administration (FDA). This is a phase one study investigating the safety and efficacy profile of allogeneic cord blood hematopoietic progenitor cells (HPC, Cord Blood), when administered by intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past nine days.
To follow the ethical guidelines in clinical research, BHITS retrospectively registered another clinical study entitled “Retrospective chart review study of umbilical cord stem cell therapy for stroke” at the International Standard Randomised Controlled Trials Number (ISRCTN) registry (Biomed Central, Part of Springer Nature). This retrospective chart review study is aimed to analyze the impact of human umbilical cord blood mononuclear cell therapy on mobility and muscle strength of upper and lower extremities, and neurological function in subjects with ischemic and hemorrhagic stroke.
“Our research is becoming stronger and we are gaining momentum. It is important to show the scientific community and also the general public the promising results of our research. We are strong believers in stem cell therapies, and are working tirelessly on making it available for a wider audience”, said Brian Mehling, MD, CMO of BHITS, and the Principal Investigator of above mentioned clinical trials.
BHI Therapeutic Sciences is pioneering ethical, effective, safe and affordable stem cell treatment therapies utilizing cord blood stem cells. Our stem cell products evaluated in clinical studies are collected in accordance with Good Tissue Practice to ensure safety. The studies have been conducted following approval by an Investigational Research Board and in accordance with Good Clinical Practice. Our results show our cellular products are safe and effective in the improvement of symptoms related to chronic inflammation, spinal cord injury, stroke, musculoskeletal disorders, and other medical conditions. Multiple studies of umbilical cord blood-derived stem cell therapies and adipose-derived stem cell therapies are currently under investigation in clinical trials for a wide range of medical conditions and show promising results. For more information, please visit www.bhisciences.com.
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health and is the largest clinical trials database, currently holding registrations from over 230,000 trials from 195 countries in the world. The National Library of Medicine in the National Institutes of Health made ClinicalTrials.gov available to the public via the internet on February 29, 2000. In this initial release, ClinicalTrials.gov primarily included information about NIH-sponsored trials, omitting the majority of clinical trials being performed by private industry. For more information, please visit www.ClinicalTrials.gov.
The ISRCTN registry is a primary clinical trial registry recognized by WHO and ICMJE that accepts all clinical research studies (whether proposed, ongoing or completed), providing content validation and curation and the unique identification number necessary for publication. All study records in the database are freely accessible and searchable. ISRCTN supports transparency in clinical research, helps reduce selective reporting of results and ensures an unbiased and complete evidence base. For more information, please visit www.isrctn.com.
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