Profile of the Pleximmune blood test for transplant rejection risk prediction

Sindhi, Rakesh; Ashokkumar, Chethan; Higgs, Brandon W.; Levy, Samantha; Soltys, Kyle; Bond, Geoffrey; Mazariegos, George; Ranganathan, Sarangarajan; Zeevi, Adriana

doi:10.1586/14737159.2016.1139455

Cited by 15 publications

(13 citation statements)

References 27 publications

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“…The expression of CD154 on patient's cells is compared to the basal level of expression on third party cells, an increased ratio being in favor of an acute rejection. This is not an IFA per se , as no stimulation step is performed, but rather a surrogate marker of the activity of T-cytotoxic memory cells ( 27 ).…”

Section: Introductionmentioning

confidence: 99%

Immune Functional Assays, From Custom to Standardized Tests for Precision Medicine

et al. 2018

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The immune response is a dynamic system that maintains the integrity of the body, and more specifically fight against infections. However, an unbalanced host immune response is highlighted in many diseases. Exacerbated responses lead to autoimmune and allergic diseases, whereas, low or inefficient responses favor opportunistic infections and viral reactivations. Conflicting situations may also occur, such as in sepsis where inflammation and compensatory immunosuppression make it difficult to deploy the appropriate drug treatment. Until the current day, assessing the immune profile of patients remains a challenge. This is especially due to the inter-individual variability—a key feature of the immune system—which hinders precise diagnosis, prognosis, and therapeutic stratification. Our incapacity to practically interpret the host response may contribute to a high morbidity and mortality, such as the annual 6 million worldwide deaths in sepsis alone. Therefore, there is a high and increasing demand to assess patient immune function in routine clinical practice, currently met by Immune Functional Assays. Immune Functional Assays (IFA) hold a plethora of potentials that include the precise diagnosis of infections, as well as prediction of secondary and latent infections. Current available products are devoted to indirect pathogen detection such as Mycobacteria tuberculosis interferon gamma release assays (IGRA). In addition, identifying the status and the underlying factors of immune dysfunction (e.g., in septic patients) may guide immune targeted therapies. Tools to monitor and stratify the immune status are currently being studied but they still have many limitations such as technical standardization, biomarkers relevance, systematic interpretation and need to be simplified, in order to set the boundaries of “healthy,” “ill,” and “critically ill” responses. Thus, the design of new tools that give a comprehensive insight into the immune functionality, at the bedside, and in a timely manner represents a leap toward immunoprofiling of patients.

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Section: Introductionmentioning

confidence: 99%

Immune Functional Assays, From Custom to Standardized Tests for Precision Medicine

et al. 2018

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“…Proteomic and cytokine analysis of ostomy effluent has demonstrated the critical role of the innate immune system during episodes of ACR [25]. In addition, the Pleximmune™ test (Plexision Inc., Pittsburgh, PA, USA) is an established, FDA approved assay that employs immunophenotyping of allospecific CD154+ T-cytotoxic memory cells to identify pediatric ITx recipients who are at risk for rejection [26,27].…”

Section: Discussionmentioning

confidence: 99%

Characterization of T cell immunophenotypes in intestinal transplantation: A pilot study

Guerra

Rossetti

Zhang

et al. 2018

Transplant Immunology

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Immunophenotyping of peripheral blood mononuclear cells has been shown to be a useful, non-invasive method of predicting acute cellular rejection (ACR) following intestinal transplantation (ITx). Our objectives were to characterize differences in the T cell immunophenotype of ITx recipients in peripheral blood samples (1) collected late versus early after ITx and (1) associated with episodes of ACR and infectious enteritis. An IRB-approved, cross-sectional study of ITx recipients was performed. Peripheral blood samples were collected during normal visits and episodes of allograft dysfunction. A total of 38 patients were included in the analysis: 31 ITx recipients (87% liver-inclusive allografts) and 7 intestinal failure control patients. Of the ITx patients, 26 patients were pediatric patients (<21 years). A total of 70 samples were analyzed from ITx recipients, including 51 during normal visits and 19 during episodes of allograft dysfunction (median of 2 samples per patient; range of 1-6 samples per patient). In the late (n = 32) versus early post-ITx (n = 19) normal samples, there was a significantly higher percentage of central memory CD4 T cells (p = .001). In the ACR (n = 5) versus infectious enteritis (n = 14) samples, there was a higher percentage of CD8 T cells expressing HLA-DR (p = .002), CD57 (p < .001), and KLRG1 (p < .001) and a higher percentage of CD4 T cells expressing CD57 (p = .03). Additional studies are needed with larger cohorts to validate these changes in the T cell immunophenotype. Further elucidating T cell immunophenotypes in ITx will lead to a better understanding of immune mechanisms of allograft dysfunction, identification of potential biomarkers in ITx, and optimized selection of immunosuppressive therapies.

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“…Routine Pleximmune™ assays have been performed with her most recent assay demonstrating an immunoreactivity index of 0.84. The Pleximmune™ assay is an FDA approved blood test that measures alloantigen‐specific CD154+ T‐cytotoxic memory cells to predict acute cellular rejection where a value ≥1.1 implies an increased risk of rejection 3 . The patient has not had any major infectious complications, return of her GVHD and her T‐cell macrochimerism has been undetectable since her clinical GVHD.…”

Section: Current Clinical and Immune Statusmentioning

confidence: 99%

Operational tolerance after pediatric composite liver‐pancreas‐intestine transplantation following severe graft‐versus‐host disease

Osborn

Nathan

Tiao

et al. 2021

Pediatric Transplantation

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Background While operational tolerance has been previously described in isolated intestinal transplant, reports of this phenomenon in combined liver‐intestine transplant are lacking. Case Description We detail a unique case of a patient who received a composite allograft including liver, pancreas, and small bowel due to short gut syndrome secondary to gastroschisis complicated by volvulus. The indication for transplantation was permanent dependence on total parenteral nutrition, end‐stage liver disease, recurrent sepsis, and persistent stomal variceal hemorrhage. The patient developed severe graft‐versus‐host disease with grade 3 skin involvement, ophthalmic, and pulmonary involvement with 53% donor T‐cell chimerism. She required aggressive therapy including high‐dose methylprednisolone, rituximab, cyclophosphamide, and alemtuzumab. Due to infection concerns following depletion of her lymphocytes, immunosuppression was discontinued with close surveillance of her allograft. Nearly 10 years later, the patient has continued off all immunosuppression without evidence of rejection or graft dysfunction and demonstrates immunocompetence with normal functional immune assays and development of appropriate live vaccination titers. Conclusion This report of operational tolerance following pediatric composite liver‐pancreas‐intestine transplantation provides evidence that the complex immunologic balance in intestinal transplantation may on rare occasions favor immunosuppression reduction or even discontinuation. Future trials of immunosuppression minimization in this population may be warranted.

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Profile of the Pleximmune blood test for transplant rejection risk prediction

Cited by 15 publications

References 27 publications

Immune Functional Assays, From Custom to Standardized Tests for Precision Medicine

Immune Functional Assays, From Custom to Standardized Tests for Precision Medicine

Characterization of T cell immunophenotypes in intestinal transplantation: A pilot study

Operational tolerance after pediatric composite liver‐pancreas‐intestine transplantation following severe graft‐versus‐host disease

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