An interventional study of Leukapheresis in Covid19 and SARS-CoV-2, sponsored by Serhat Gumrukcu, MD PhD. Suspended at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by Serhat Gumrukcu, MD PhD · Not applicable, Interventional, and Basic science
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.
This protocol is to collect blood and PBMC specimens from individuals with active of past COVID-19 infection. The first blood draw will be done at the first study visit and if eligible, the second collection will be done via leukapheresis at the second visit. The leukapheresis procedures will follow the facility's standard operating procedures and protocol requirements for leukapheresis.
Donors will be males or females between and including the ages of 18 years and 60 years. Volunteers will provide written informed consent and meet all inclusion and exclusion criteria. Each participant can be in the study for up to 180 days (6 months).
The study will be conducted in accordance with human research for the purposes of obtaining clinical specimens for research. There is no endpoint for this study, however, data collected from this study will include, but not be limited to, gender, demographics, medical history, clinical laboratory values, and volume of the blood collected. The data will be summarized in future studies reporting results from a future clinical trial under FDA IND.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 25 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Serhat Gumrukcu, MD PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Venous blood and apheresis collection will be conducted
Other: Leukapheresis
Blood collection and PBMC collection via apheresis machine will be conducted
Also known as: Mononuclear cell collection
Cellular immune system profiling
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.
Time frame: Up to 20 days
Innate immune system profiling
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.
Time frame: Up to 100 days
Expansion of virus-specific innate immune cells
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.
Time frame: Up to 100 days
Plan to share: No
No publications or documents are linked to this record.
This study is suspended, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Serhat Gumrukcu, MD PhD