BackgroundThe COVID-19 pandemic presented an unprecedented challenge to identify effective drugs for prevention and treatment.ObjectiveTo characterize acute renal injury (AKI) in patients with COVID-19 and their relation with clinical outcomes within the framework of the SENTAD COVID clinical trial at the Abu Dhabi Stem Cells Center.MethodsAbu Dhabi Stem Cell Center (ADSCC) proposed a prospective clinical trial nebulization treatment with autologous stem cells (Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)), at Abu Dhabi hospitals.Participants20 treated patients were compared with 23 not treated patients. Both groups received COVID 19 standard treatment.OutcomesAfter the results were collected, this study was created to determine the impact of the disease on the renal function and the efficacy of the therapy on patient’s outcomes.ResultsOne third of the critical patients studied suffered kidney failure. Patients in the treated group showed a favorable tendency to improve in contrast to those in the control group. Less patients from group A suffered from sepsis in comparison with the group B (25% vs 65%), HR=0.38, (95% Confidence Interval: 0.16 – 0.86), *p=0.0212. These results suggested a NNT=2.5. An improvement in lymphocyte count, CRP, and shorter hospital stay after treatment was evidenced, which led to less superinfection and sepsis in the treated group.ConclusionsThe proposed anti-inflammatory effect of the stem cells, offers a great promise for managing the illness, emerging as a crucial adjuvant tool in promoting healing and early recovery in severe COVID-19 infections and other supportive treatments.ARTICLE SUMMARYOur study had several strengths and limitation: It was a randomized trial.The treatment showed a positive result, providing evidence that this intervention is effective in routine practice.We found fewer complications related to prolonged hospital stay in the treated group.The is the small number of participants.It was carried out in 4 different hospitals, each with different criteria for the selection of the initial empirical antimicrobials, which can cause multiple resistant germs.
Background: The novel SARS-Cov-2 has caused the COVID-19 pandemic. Currently, with insufficient worldwide vaccination rates, the identification of treatment solutions to reduce the impact of the virus is urgently needed. Method: An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the “SENTAD-COVID Study” was conducted by the Abu Dhabi Stem Cells Center under conditional exceptional approval by the Emirates Institutional Review Board (IRB) for COVID-19 Research Committee from April 4 to July 31, 2020, using an autologous peripheral blood nonhematopoietic enriched stem cell cocktail (PB-NHESC-C) administered by compressor (jet) nebulization as a complement to standard care therapy. The primary endpoints include safety and efficacy assessments, adverse events, the mortality rate within 28 days, and the time to clinical improvement as measured by a 2-point reduction on a seven-category ordinal scale or discharge from the hospital, whichever occurred first. Results: The study included a total of 139 randomized COVID-19 patients with 69 in the experimental group and 70 in the control group (standard care). Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group. Adverse events occurred in 43 (62.32%) patients receiving PB-NHESC-C vs. 44 (62.86%) in the control group, and most adverse events were related to the disease. After the first nine days of the intervention, 67.3% of cocktail-treated patients recovered and were released from hospitals compared to 53.1% (RR=0.84; 95% CI, 0.56-1.28) in the control group. Improvement, i.e., at least a 2-point reduction in the severity scale, was more frequently observed in cocktail-treated patients (42.0%) than in controls (17.0%) (RR=0.69; 95% CI, 0.56-0.88). Conclusions: Cocktail treatment improved clinical outcomes without increasing adverse events. Thus, the nebulization of PB-NHESC-C was safe and effective for treatment in most of these patients. Trial registration: ClinicalTrials.gov. NCT04473170. Registered 16 July 2020. Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT04473170.
BackgroundCOVID-19 is the defining global crisis of our time. Secondary complication such as urinary tract infections and sepsis, worsen the already established problem, creating a new challenge.ObjectiveTo characterize the features and outcomes in COVID-19 patients with sepsis and urinary tract infection.MethodsAn observational and analytical study was conducted within the framework of the SENTAD COVID clinical trial at the Abu Dhabi Stem Cells Center, were the patients received a nebulization therapy with the use of autologous stem cells (group A). Those patients were compared with a not stem cells treated control arm (group B), and both received the UAE COVID 19 standard management. An analysis of the culture samples, antimicrobial agents and the efficacy of the therapy on patient’s outcomes was done.ResultsA significant difference between the groups was found in the UTI incidence (p=*0.0206). Patients in group A showed a lower tendency to sepsis in comparison with group B (7% vs 21%), HR=0.35, (95% Confidence Interval: 0.13 – 0.91), p=0.0175. It was calculated a NNT=7.3. Candida albicans was the most frequently agent causing sepsis and UTI. The massive use of broad-spectrum antimicrobials was striking.ConclusionsWe found a protective factor of stem cells against secondary infection in COVID 19 cases, in terms of sepsis and UTI. The suggested immunomodulatory effect of stem cells offers a therapeutic strategy to manage the disease and avoid several complications. Antimicrobial agents can lead to increased opportunistic infections, so a rational approach to these treatments must be considered.
Evaluation of immunoprofile as predictive and prognostic biomarker are essential to follow up patients in Multiple Myeloma after autologous hematopoietic stem cells transplantation (AHSCT). It can be defining the engraftment and predicts complications. An AHSCT was performed for the first time in the United Arab Emirates to treat a patient with multiple myeloma. We apply the evaluation of the patient's immune status before and during the early follow-up by flow and mass cytometry. The analysis revealed a decrease in all leukocyte populations in blood seven days after transplantation, mainly of B and T helper lymphocytes. The patients showed diarrhea and cellulitis as complications. An increase in regulatory T and NK lymphocytes was evidenced at the same time. 28 days’ post-transplantation, all lymphocyte populations were recovered, except for B lymphocytes, a high level of T regulatory and NK was maintained. The early immune restoration coincided with the recovery of the complications presented by the patient. the leukocyte composition of apheresis was similar to that found in blood at baseline time. Our study evidenced that the extended immunoprofile by mass cytometry could be useful to predict the outcome and response to transplantation.
Background SARS-CoV-2 is a highly contagious virus that spread worldwide with a rapid increase in the number of deaths. In March 2020, the WHO declared SARS-CoV-2 a pandemic. The primary diagnostic test is reverse transcription-polymerase chain reaction, but chest X-ray and computed tomography have become the typical diagnostic tools used to detect abnormal lung changes. Within the framework of the SENTAD COVID Study clinical trial, an observational and analytical study was conducted, where the patients received nebulization therapy with the use of autologous stem cells (group A) compared to the control arm (group B). Both groups received the UAE SARS-CoV-2 standard management. Radiological images of each patient were collected within 24 h of inclusion in the trial and during follow-up. Herein, we describe and evaluate the radiological findings and outcomes. Results A total of 139 subjects were included in our analysis, 69 in group A and 70 in group B. The most common finding was ground glass opacifications, followed by patchy consolidations, with 20% normal radiological images scored 3 from admission until discharge (p < 0.0001). Our results suggest a significant improvement in radiological images after treatment secondary to the stem cell effect of reducing inflammation and stimulating the pneumological healing process. Conclusions The use of novel therapies, such as stem cells, shows efficacy not only in terms of the control of clinical and paraclinical signs but also in the radiological changes described in the disease. Trial registration Study evaluating the safety and efficacy of autologous non-hematopoietic peripheral blood stem cells in COVID-19. Trial registration number: NCT04473170. Date of registration: 16 July 20202. Retrospectively registered.
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