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.

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

Severe Acute Respiratory Syndrome (SARS) Pneumonia

Stem Cell Educator-Treated Mononuclear Cells Apheresis

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

Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

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

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.

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.

Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.

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.

Tianhe Stem Cell Biotechnologies Inc.

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.

Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:
Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months.
Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.
Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.

Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:
Group B: 12 subjects with 1 to 2 outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0.

Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:
Group C: 12 subjects with zero outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0.

Herpes Labialis

2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours.

Squaric Acid Dibutyl Ester

Prism Clinical Research, LLC

Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)

A Phase I Study of the Immune Response to Herpes Simplex Virus Type 1 (HSV-1) and General Immune Health in Subjects Infected With HSV-1

Cell Counts (Lymphocyte, T cell, B call, CD4, CD8, natural killer cells counts)

Serum Cytokine Levels ( IL2R, IL12, INFG, IL4, IL5, IL10, IL13, IL1B, IL6, IL8, TNFA, IL2, IL17) in pg/mL

RNA gene expression arrays for 42 cytokine and immune related genes, expressed as ratio of absolute gene expression in PBMCs for each group (A, B, C, those with 0, few, or 6 or more herpes labialis outbreaks in the prior 12 months) on Day 0,1 and 2 and a each test condition (no stimulus, HSV-1, HSV-infected cell extracts, or Candida).

PBMC proliferation in response to 3 stimuli: HSV-1 virus, HSV-1-infected cell extracts, and Candida albicans extract.

Squarex, LLC

Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:
x Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months x Group B: 12 subjects with 1 to 2 outbreaks in the past 12 months x Group C: 12 subjects with zero outbreaks in the past 12 months Subjects in group A will receive 2% SADBE dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.
Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.

Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).

International Research Partners, LLC

A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis

To assess local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).

To assess efficacy of repeat topical application of 2% and 0.5% SADBE in the prevention of herpes labialis episodes.

Subjects will receive on a double blind basis one of two treatment regimens:
Group A: 15 subjects, treated with 2% SADBE on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Group B: 15 subjects, treated with 2% SADBE on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
And subjects will be recruited on an open label basis to two other treatment regimens:
Group C: 15 subjects, treated with 2% SADBE on day 0, month 3, and month 6.
Group D: 15 subjects, treated with 2% SADBE on day 0 and month 6.

The double-blinding only applies between groups A and B. Subjects for groups C and D will be recruited on an open label basis.

alopecia areata/karščiavimas

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

Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)

A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis

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