Currently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a RNA virus that display high similarity in both genomic and proteomic profiling with SARS-CoV that first emerged in humans in 2003 in China. Therefore, preventing and controlling the pandemic occurrences are extremely urgent as a global top priority. Due to the lack of effective antiviral drugs, patients may be treated by only addressing their symptoms such as reducing fever. Clinical autopsies from SARS-CoV-infected patients demonstrated that there were major pathological changes in the lungs, immune organs, and small systemic blood vessels with vasculitis. However, the detection of SARS-CoV were primarily found in the lung and trachea/bronchus, but was undetectable in spleen, lymph nodes, bone marrow, heart and aorta, highlighting the overreaction of immune responses induced by viral infection were really harmful, resulting in the pathogenesis of lungs, immune organs, and small systemic blood vessels. To this respect, immune modulation strategy may be potentially beneficial to enhance anti-viral immunity and efficiently reduce the viral load, improve clinical outcomes, expedite the patient recovery, and decline the rate of mortality in patients after being infected with SARS-CoV-2. Tianhe Stem Cell Biotechnologies Inc. has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata (AA) and other autoimmune diseases. SCE therapy uses human multipotent cord blood stem cells (CB-SC) from human cord blood. Their properties distinguish CB-SC from other known stem cell types, including mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC). Several clinical studies show that SCE therapy functions via CB-SC induction of immune tolerance in autoimmune T cells and restore immune balance and homeostasis in patients with T1D, AA and other inflammation-associated diseases. To correct the overreaction of overreaction of immune responses, the investigators plan to treat SARS-CoV-2 patients with Stem Cell Educator therapy.
This is a prospective, two-arm, partially masked, single center clinical study to assess the safety, feasibility, and efficacy of SCE therapy for the treatment of patients with SARS-CoV-2 infection. Patients will be evaluated by the study principal investigator or co-investigators. Informed consent will be obtained at the initial screening visit. Subjects who meet all criteria will be scheduled for treatment. All enrolled subjects will receive one treatment with the SCE therapy consisting of a single session of mononuclear cells (MNC) collection by apheresis of blood. The MNC product will be treated with the SCE, and followed by an infusion intravenously back to the patient. The SCE-treated subjects will be evaluated according to the schedules of follow-up studies within 4 weeks.
Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis
SCE therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent CB-SC in vitro, and returns the "educated" autologous immune cells to the patient's circulation.
Inclusion Criteria: 1. Adult patients (18 years) 2. Must have a clinical diagnosis of SARS-CoV-2, with at least one of clinical symptoms (e.g., fever ≥38°C, fatigue, cough) and a positive result by the reverse-transcription polymerase chain reaction (RT-PCR) testing 3. Patients must not have received any antiviral treatments known to affect SARS-CoV-2 4. Patients must agree that they are not permitted to use any other treatment to affect SARS-CoV-2 during a period of 6 months after undergoing SCE therapy 5. Adequate venous access for apheresis 6. Ability to provide informed consent 7. For female patients only, willingness to use FDA-recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePubli… 451.pdf) until 6 months post treatment. 8. Must agree to comply with all study requirements and be willing to complete all study visits
Exclusion Criteria: 1. AST or ALT 2 > x upper limit of normal. 2. Abnormal bilirubin (total bilirubin > 1.2 mg/dL, direct bilirubin > 0.4 mg/dL) 3. Creatinine > 2.0 mg/dl. 4. Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist. 5. Known active infection such as Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) 6. Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers 7. Use of immunosuppressive medication within one month of enrollment including but not limited to cyclosporine, tacrolimus, sirolimus, and chemotherapy. 8. Anticoagulation other than ASA. 9. Hemoglobin < 10 g/dl or platelets < 100 k/ml
10. Is unable or unwilling to provide informed consent
11. Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
Heng Li, MD,PhD
Tianhe Stem Cell Biotechnologies Inc.