- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04299152
Stem Cell Educator Therapy Treat the Viral Inflammation in COVID-19
June 25, 2021 updated by: Throne Biotechnologies Inc.
Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laura Zhao
- Phone Number: 2019880290
- Email: connect@ThroneBio.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stem Cell Educator therapy treat patients with SARS-CoV-2
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.
|
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.
|
No Intervention: Conventional treatment of patients with SARS-CoV-2
Patients will receive the regular treatments by only addressing their symptoms such as reducing fever and cough.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the number of Covid-19 patients who were unable to complete SCE Therapy
Time Frame: 4 weeks
|
The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examine the percentage of activated T cells after SCE therapy by flow cytometry
Time Frame: 4 weeks
|
Measurements of immune markers' changes will be preformed by flow cytometry such as activated T cells.
Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
|
4 weeks
|
Assess the percentage of Th17 cells after SCE therapy by flow cytometry
Time Frame: 4 weeks
|
Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells.
Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
|
4 weeks
|
Chest imaging changes by computed tomography (CT) scan of the chest
Time Frame: 4 weeks
|
Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.
|
4 weeks
|
Quantification of the SARS-CoV-2 viral load by real time RT-PCR
Time Frame: 4 weeks
|
To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Heng Li, MD,PhD, Throne Biotechnologies Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 10, 2021
Primary Completion (Anticipated)
April 9, 2022
Study Completion (Anticipated)
June 10, 2022
Study Registration Dates
First Submitted
February 28, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (Actual)
March 6, 2020
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 25, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-TH-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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