Stem Cell Educator Therapy Treat the Viral Inflammation in COVID-19
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04299152 |
Recruitment Status :
Not yet recruiting
First Posted : March 6, 2020
Last Update Posted : June 30, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Severe Acute Respiratory Syndrome (SARS) Pneumonia | Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model 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. |
Masking: | Single (Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) |
Estimated Study Start Date : | November 10, 2021 |
Estimated Primary Completion Date : | April 9, 2022 |
Estimated Study Completion Date : | June 10, 2022 |

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.
|
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. |
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.
|
- 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.
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299152
Contact: Laura Zhao | 2019880290 | connect@ThroneBio.com |
Study Director: | Heng Li, MD,PhD | Throne Biotechnologies Inc. |
Publications:
Responsible Party: | Throne Biotechnologies Inc. |
ClinicalTrials.gov Identifier: | NCT04299152 |
Other Study ID Numbers: |
2020-TH-001 |
First Posted: | March 6, 2020 Key Record Dates |
Last Update Posted: | June 30, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
severe acute respiratory syndrome coronavirus Immune modulation Stem Cell Educator therapy |
Severe Acute Respiratory Syndrome Syndrome Inflammation Disease Pathologic Processes Respiratory Tract Infections Infections |
Respiratory Tract Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases |