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Area of Science:

  • Regenerative Medicine
  • Hematology
  • Biotechnology

Background:

  • Clinical cellular therapeutics (CCTs) show promise for treating conditions like stroke and myocardial infarction.
  • However, many CCTs express tissue factor (TF), a protein that can stimulate blood coagulation.
  • This TF expression may pose a risk for thrombotic events in patients receiving CCTs.

Purpose of the Study:

  • To quantify the procoagulant activity of various CCTs.
  • To determine the relationship between TF expression levels and procoagulant activity in CCTs.
  • To assess the impact of TF on coagulation parameters in vitro.

Main Methods:

  • Collected CCT samples from diverse sources (bone marrow, adipose, umbilical cord, etc.).
  • Quantified TF expression and cell phenotype using flow cytometry.
  • Measured in vitro procoagulant activity using thromboelastography and calibrated thrombogram.
  • Utilized fluorescence-activated cell sorting (FACS) to isolate high- and low-TF expressing cell populations.
  • Employed a TF-neutralizing antibody to confirm TF's role in observed procoagulant effects.

Main Results:

  • All tested CCTs exhibited procoagulant activity directly correlated with TF expression.
  • Increased TF expression led to decreased clotting time and reduced thrombin generation.
  • High-TF expressing cells demonstrated significantly greater procoagulant effects compared to low-TF cells from the same donor.
  • A TF-neutralizing antibody partially or fully reversed the procoagulant activity in tested CCT samples.

Conclusions:

  • CCTs display a wide range of procoagulant activities, primarily driven by TF expression levels.
  • Higher TF load in CCTs enhances their procoagulant potential, which can be mitigated by TF-blocking antibodies.
  • TF expression levels may become a critical safety criterion for the clinical application of CCTs in future trials.