Production of clinical-grade SARS-CoV-2 antigen specific cytotoxic T lymphocytes

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005864

Enrollment

100

Registered

2021-02-04

Start date

2021-01-18

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : Blood collection of whole blood 300cc or leukapheresis 250cc, once Periphieral blood mononuclear cells are isolated and the cells are expanded in culture using cy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For COVID-19 treated individuals: 1. Those who consent to the study 2. Aged 20 - to 65 years old 3. Individual who has been diagnosed with COVID-19 and released from quarantine, that is, the person who meets all the criteria for public release by the CDC: A. (clinical standard): no fever and no clinical symptoms B. (diagnostic criteria) PCR test results are negative twice every 24 hours For health donors: 1. Those who consent 2. Aged 20 to 65 years old 3. Those who do not have any fever or respiratory symptoms 4. Negative for Anti-SARS-CoV-2 Ab IgG antibodies

Exclusion criteria

Exclusion criteria: 1. Those who do not consent 2. Those under 20 or over 65 years of age 3. Positive for Anti-SARS-CoV-2 IgG antibodies 4. Positive for HIV, syphilis or hepatitis B and C carriers. 5. Those with any active infections requiring systemic medical treatment 6. Those who have been diagnosed with any other serious diseases

Design outcomes

Primary

Measure	Time frame
Expression of CD3 T cell marker in culture-expanded virus antigen specific T cells by flow cytometry;Expression of CD14 monocyte and CD19 B cell marker in culture-expanded virus antigen specific T cells by flow cytometry;Determining antigen specificity by detecting IFN-gamma secretion of culture expanded virus antigen-specific T cells against coronavirus-19 peptides through ELISPOT assay	—

Secondary

Measure	Time frame
Fold expansion following culture of SARS-CoV-2 virus antigen peptide mixture treated peripheral nucleated cells;Characterization of cultured cells (Phenotypical analysis of cultured cells through flow cytometry)	—

Countries

Korea, Republic of

Contacts

Public ContactDong Wook JeKarl

The Catholic University of Korea, Seoul St. Mary's Hospital

Outcome results