In June 2018, BHI Therapeutic Sciences (BHITS) received FDA endorsement of Investigator-led Investigational New Drug (IND) application for initiation of a clinical study of FDA-approved cell therapy (HPC, cord blood) for the treatment of acute ischemic stroke. The study is further approved by an Institutional Review Board (IRB) and registered on the clinicaltrials.gov database (NCT03735277). BHITS plans to submit an IND application for the initiation of a clinical study of FDA-approved cell therapy (HPC, cord blood) for the treatment of knee osteoarthritis-associated pain. Many studies have shown that MSCs have immunomodulatory, antimicrobial, anti-inflammatory, and tissue repair functions, which have great potential for the prevention and treatment of viral diseases. The rationale for BHITS' new study is to further characterize the safety and efficacy of human umbilical cord Mesenchymal Stem Cells (hUC-MSCs), delivered via an intravenous route of administration, for the indication of novel coronavirus causing severe pneumonia. In March 2020, the study entitled “Retrospective Case Series Study of Umbilical Cord Mesenchymal Stem Cell Therapy in Previously Treated Subjects with Pneumonia Caused by 2019 Novel Coronavirus” was approved by the Institute of Regenerative and Cellular Medicine IRB. In April 2020, two clinical study proposals for hUC-MSCs in the Treatment of Hospitalized Subjects with Severe COVID-19 Pneumonia and Continued Respiratory Disability after Acute COVID-19 Infection were submitted to medicalcountermeasures.gov to request the U.S. government Coronawatch Meeting. The study is currently under review. In April 2020, two clinical study proposals for hUC-MSCs in the Treatment of Hospitalized Subjects with Severe COVID-19 Pneumonia and Continued Respiratory Disability after Acute COVID-19 Infection were submitted to a special emergency program created by the FDA – Coronavirus Treatment Acceleration Program (CTAP). The study is currently under review. In May 2020, two clinical study proposals for hUC-MSCs in the Treatment of Hospitalized Subjects with Severe COVID-19 Pneumonia and Continued Respiratory Disability after Acute COVID-19 Infection were submitted to the Federal Ministry of Education and Research (Germany).
Nov. 30, 2021
“Retrospective Case Series Study of Dendritic Cell-Cytokine Induced Killer Cell Therapy in Previously Treated Subjects with Lymphatic Leukemia and Peritoneal Cancer”
Protocol #: BHI21-RCS-DCCIK Institute of Regenerative and Cellular Medicine IRB Approval #: IRCM-2-21-308
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Please click here to see our research data on stroke.
Stroke Research Video BHI Stem Cells
Please click here to see our research on spinal cord injury.