The status of FDA studies conducted by BHI Therapeutic Sciences/COVID-19
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 treatment of acute ischemic stroke. The study is further approved by an Institutional Review Board (IRB) and registered on the clinicaltrials.gov database (NCT0373527).
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, being a great potential for the prevention and treatment of viral diseases. The rationale for BHITS new study is the further characterization of 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 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 FDA – Coronavirus Treatment Acceleration Program (CTAP). The study is currently under review.
In collaboration with DataRevive USA LLC, BHITS is developing Pre-IND package for hUC- MSCs treatment of COVID-19 Pneumonia. Results of our previous clinical studies and nonclinical studies will be used to support our IND application.
Cell Quality Certificates
BHI Therapeutic Sciences has taken every precaution to ensure the safety and viability of administered stem cells. BHI Therapeutic Sciences stem cells are tested for sterility, infectious diseases and have high cell count and viability. Every unit of Human Umbilical Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells has the Cell Quality Certificate with the following information: Virus Tests (Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency virus and Treponema pallidum), Microbiological Tests (Bacteria, Fungus, Mycoplasma, Endotoxin), the cell count and viability.
Human Umbilical Cord Mesenchymal Stem Cells
Human Umbilical Cord Blood Mononuclear Cells
Investigator-led IND (Investigational New Drug) application
Stroke is a leading cause of adult disability worldwide and the second highest cause of death in the world. Approximately 87% of adult strokes are ischemic in etiology. Ischemic strokes occur when cerebral blood flow is blocked by a clot or mechanical event. Tissue plasminogen activator (tPA) therapy to dissolve clots is the current standard of care for treatment; however, it has a very narrow window of effectiveness, and may increase the risk of cerebral hemorrhage. To date, there are no clinically effective pharmacotherapies that can promote or facilitate cellular functional recovery after an ischemic stroke. Human umbilical cord blood cell therapy is a promising treatment for ischemic stroke.
FDA endorsed our Investigator-led IND (Investigational New Drug) application to allow for initiation of a clinical study of an FDA-approved cell therapy (Hematopoietic Progenitor Cell (HPC), 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.
BHI Therapeutic Sciences is in the process of preparation of Investigator-led IND application to allow for initiation of a clinical study of an FDA-approved cell therapy (HPC, cord blood) for treatment of osteoarthritis. This prospective, open-label, single-center, exploratory clinical study will be designed to characterize the safety and efficacy profile of HCP, cord blood, when administered by intra-articular injection, in subjects with osteoarthritis.
Institutional Review Board (IRB) approved studies
Evaluation of Immune Response to Intravenously Administered Human Cord Blood Stem Cells in the Treatment of Symptoms Related to Chronic Inflammation
In the United States we completed safety study of human cord blood stem cells application in the therapy of symptoms related to chronic inflammation. More than 100 research subjects were included in the study. Results are showing that human umbilical cord blood stem cells are safe and effective in the improvement of symptoms related to chronic inflammation. Research subjects did not develop serious adverse reactions. Moreover, 3 and 6 months after stem cell therapy, subjects displayed a significant increase in energy level as well as a significant decrease of their pain level.
Please click on the links below to read our published research papers on chronic inflammation.
Retrospective Chart Review Study of Human Umbilical Cord Blood Stem Cell Therapy in Subjects with Spinal Cord Injury
Thirty patients with SCI were randomly selected from seventy treated with human umbilical cord blood mononuclear cells at the Wuhan Hongqiao Brain Hospital between March 2009 and March 2012. Another thirty patients with SCI, who received only traditional therapy and no stem cell therapy, were included as the control group. Research subjects showed significant improvement in pain and temperature sensation, lower limb muscle strength, bladder and gastrointestinal function
Please click on the link below to read our published research paper on SCI.
Retrospective Chart Review Study of Human Adipose Tissue Derived Mesenchymal Stem Cell Therapy in Subjects with Musculoskeletal Conditions
Musculoskeletal disorders are injuries or pain in the human musculoskeletal system with the consequent loss of mobility, pain and reduction in the quality of life. Pain is a major healthcare problem affecting individuals with arthritis and musculoskeletal disorders. In the period from 2015 to 2016, 207 subjects underwent the intra-articular therapy with their own stromal vascular fraction cells at the Malacky Hospital (Bratislava, Slovakia). Affected areas included knee and hip joints (right and left) with arthritis stage I-IV (1 – minor, 4 – severe). Research study showed that intra-articular injection of adipose tissue-derived mesenchymal stem cells (ADSCs) was effective in the improvement of some symptoms related to musculoskeletal conditions. Significant decrease in pain sensation and mobility improvement were observed six months after ADSC therapy.
Please click on the link below to see our poster presented at AAOS 2018 annual meeting (New Orleans, LA, 2018).
Retrospective Chart Review Study of Human Umbilical Cord Blood Stem Cell Therapy in Subjects with Stroke
Human umbilical cord blood cell therapy of 97 research subjects with sequelae of cerebrovascular hemorrhage and cardiovascular accident (CVA) (ie, stroke) sequelae showed significant improvement of mobility of upper and lower extremities, muscle strength of upper and lower limbs and neurological function after therapy.
Please click on the link below to see our poster presented at the 7th Annual German Stem Cell Network Conference (Germany, Berlin, 2019).
Safety study of post-surgical balm application for scar reduction
The follow-up results of 37 participants after application of umbilical cord blood derived mesenchymal stem cells conditioned media-based post-surgical balm, showed that significantly high number of subjects did not develop adverse reactions. Moreover, subjects showed improvement of scar appearance on the skin after application of post-surgical balm. Significantly high number of subjects show moderate improvement of scar appearance five weeks and three months after application of post-surgical balm.
Safety Study of Alpha Blu Skin Care Line Application for Skin Anti-Aging
The follow-up results of 24 participants after application of umbilical cord blood derived mesenchymal stem cells conditioned media-based Alpha Blu Skin Care Line, showed that significantly high number of subjects did not develop adverse reactions. Results from participants’ self-assessment scales indicate improvement in overall skin appearance and skin feel, fine lines ⁄wrinkles, eye lines ⁄wrinkles and deep wrinkles appearance and uneven skin texture.