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LeukapheresisWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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D007239 Infection NIH 0.06

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There is one clinical trial.

Clinical Trials

1 Cellular Immune Profile Changes in Individuals With Active or Past COVID-19 Infection

Clinical specimens are collected from individuals either recovered from or with active SARS-CoV-2 infection to support process and analytical development for a potential cell-based immunotherapy in preclinical research, SRPH-CVD-01. SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19. Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP compliant process to be applied under the future FDA IND.

NCT04470999 Covid19 SARS-CoV-2 Other: Leukapheresis
MeSH:Infection

Primary Outcomes

Description: After the initial venous blood draw, the blood samples will be tested to measure the absolute count and percentage of B cells, monocytes, CD4+ and CD8+ T cells, gammadelta T (gdT) cells, CD3+CD56+ natural killer T (NKT) cells, and natural killer (NK) cells in total PBMCs. Data will describe the range of each cell population across participants.

Measure: Cellular immune system profiling

Time: Up to 20 days

Secondary Outcomes

Description: Innate immune system cells (gdT, NKT, and NK) will be assessed for their SARS-CoV-2 antiviral activity by stimulation and immunophenotyping. Data will report the antiviral phenotypic characteristics of these cells.

Measure: Innate immune system profiling

Time: Up to 100 days

Description: Virus-specific innate immune cells that are relevant to SRPH-CVD-01 clinical product candidate will be expanded under various conditions to assess their therapeutic and protective potential against COVID-19. Data will report the expansion rate of SRPH-CVD-01 cells. These cell will also help validate the assays and processes for the development of the SRPH-CVD-01 cell product to be used in a future clinical trials.

Measure: Expansion of virus-specific innate immune cells

Time: Up to 100 days

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