Stem Cell Educator Therapy Treat the Viral Inflammation in COVID-19

NCT04299152 | Unknown Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 2020-TH-001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Severe Acute Respiratory Syndrome (SARS) Pneumonia

Keywords

severe acute respiratory syndrome coronavirus; Immune modulation; Stem Cell Educator therapy

Outcome Measures

Primary Outcomes (1)

• Determine the number of Covid-19 patients who were unable to complete SCE Therapy

  The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.

  4 weeks

Secondary Outcomes (4)

• Examine the percentage of activated T cells after SCE therapy by flow cytometry

  4 weeks

• Assess the percentage of Th17 cells after SCE therapy by flow cytometry

  4 weeks

• Chest imaging changes by computed tomography (CT) scan of the chest

  4 weeks

• Quantification of the SARS-CoV-2 viral load by real time RT-PCR

  4 weeks

Study Arms (2)

Stem Cell Educator therapy treat patients with SARS-CoV-2

EXPERIMENTAL

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.

Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis

Conventional treatment of patients with SARS-CoV-2

NO INTERVENTION

Patients will receive the regular treatments by only addressing their symptoms such as reducing fever and cough.

Interventions

Stem Cell Educator-Treated Mononuclear Cells Apheresis COMBINATION_PRODUCT

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.

Stem Cell Educator therapy treat patients with SARS-CoV-2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients (18 years)
• 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
• Patients must not have received any antiviral treatments known to affect SARS-CoV-2
• 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
• Adequate venous access for apheresis
• Ability to provide informed consent
• For female patients only, willingness to use FDA-recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf) until 6 months post treatment.
• Must agree to comply with all study requirements and be willing to complete all study visits

You may not qualify if:

• AST or ALT 2 \> x upper limit of normal.
• Abnormal bilirubin (total bilirubin \> 1.2 mg/dL, direct bilirubin \> 0.4 mg/dL)
• Creatinine \> 2.0 mg/dl.
• Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
• Known active infection such as Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
• Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers
• Use of immunosuppressive medication within one month of enrollment including but not limited to cyclosporine, tacrolimus, sirolimus, and chemotherapy.
• Anticoagulation other than ASA.
• Hemoglobin \< 10 g/dl or platelets \< 100 k/ml
• Is unable or unwilling to provide informed consent
• Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation

Sponsors & Collaborators

• Throne Biotechnologies Inc.: lead

Related Publications (6)

• Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Yin Z, Li H, Zhang Y, Diao Y, Li Y, Chen Y, Sun X, Fisk MB, Skidgel R, Holterman M, Prabhakar B, Mazzone T. Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med. 2012 Jan 10;10:3. doi: 10.1186/1741-7015-10-3.

  PMID: 22233865 BACKGROUND

• Zhao Y. Stem cell educator therapy and induction of immune balance. Curr Diab Rep. 2012 Oct;12(5):517-23. doi: 10.1007/s11892-012-0308-1.

  PMID: 22833322 BACKGROUND

• Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Zhou H, Yin Z, Chen Y, Zhang Y, Wang S, Shen J, Thaker H, Jain S, Li Y, Diao Y, Chen Y, Sun X, Fisk MB, Li H. Targeting insulin resistance in type 2 diabetes via immune modulation of cord blood-derived multipotent stem cells (CB-SCs) in stem cell educator therapy: phase I/II clinical trial. BMC Med. 2013 Jul 9;11:160. doi: 10.1186/1741-7015-11-160.

  PMID: 23837842 BACKGROUND

• Li Y, Yan B, Wang H, Li H, Li Q, Zhao D, Chen Y, Zhang Y, Li W, Zhang J, Wang S, Shen J, Li Y, Guindi E, Zhao Y. Hair regrowth in alopecia areata patients following Stem Cell Educator therapy. BMC Med. 2015 Apr 20;13:87. doi: 10.1186/s12916-015-0331-6.

  PMID: 25896390 BACKGROUND

• Delgado E, Perez-Basterrechea M, Suarez-Alvarez B, Zhou H, Revuelta EM, Garcia-Gala JM, Perez S, Alvarez-Viejo M, Menendez E, Lopez-Larrea C, Tang R, Zhu Z, Hu W, Moss T, Guindi E, Otero J, Zhao Y. Modulation of Autoimmune T-Cell Memory by Stem Cell Educator Therapy: Phase 1/2 Clinical Trial. EBioMedicine. 2015 Nov 5;2(12):2024-36. doi: 10.1016/j.ebiom.2015.11.003. eCollection 2015 Dec.

  PMID: 26844283 BACKGROUND

• Zhao Y, Jiang Z, Delgado E, Li H, Zhou H, Hu W, Perez-Basterrechea M, Janostakova A, Tan Q, Wang J, Mao M, Yin Z, Zhang Y, Li Y, Li Q, Zhou J, Li Y, Martinez Revuelta E, Maria Garcia-Gala J, Wang H, Perez-Lopez S, Alvarez-Viejo M, Menendez E, Moss T, Guindi E, Otero J. Platelet-Derived Mitochondria Display Embryonic Stem Cell Markers and Improve Pancreatic Islet beta-cell Function in Humans. Stem Cells Transl Med. 2017 Aug;6(8):1684-1697. doi: 10.1002/sctm.17-0078. Epub 2017 Jul 7.

  PMID: 28685960 BACKGROUND

Related Links

• Throne Biotechnologies Inc

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Heng Li, MD,PhD

  Throne Biotechnologies Inc.

  STUDY DIRECTOR

Central Study Contacts

Laura Zhao

CONTACT

2019880290; connect@ThroneBio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 6, 2020
• Study Start: November 10, 2021
• Primary Completion: April 9, 2022
• Study Completion: June 10, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share