Muscle Mass Gain and Strength Recovery After Discharge of Critical Covid-19 Patients Treated With Mesenchymal Stromal Cell Infusion: A Randomized Clinical Trial
Bibliographic record
Abstract
<title>Abstract</title> <bold>Background & Aims:</bold> During the coronavirus disease 2019 (COVID-19) pandemic, patients with severe infection suffered from profound muscle loss and physical dysfunction. In this context, the immunomodulatory and anti-inflammatory properties of mesenchymal stromal cells (MSCs) could represent a new therapeutic strategy, reducing the impact of post-COVID-19 sequelae. This study aimed to evaluate the influence of MSC infusion on body composition, functionality, and the occurrence and severity of sarcopenia in critically ill COVID-19 patients after hospital discharge, correlating with clinical outcomes, viral load, and pro-inflammatory cytokines. <bold>Methods</bold>: Prospective, randomized, double-blind, placebo-controlled, phase I/II, single-center study with 16 patients (MSC = 10; placebo = 6) admitted to the Intensive Care Unit (ICU) who received three doses of 5x10<sup>5</sup> MSCs/kg intravenously. After discharge (at two and four months), the following assessments were applied: anthropometric, body composition by bioelectrical impedance analysis (BIA), and functional tests [handgrip strength (HGS), gait speed (GS), and "Timed Up and Go" (TUG)] to diagnose sarcopenia. Other assessments included cytokine dosages, viral load, laboratory tests (CRP and ferritin), and chest computed tomography (CT) scans. <bold>Results</bold>: At the end of the four months, nine patients remained in the study (MSC = 5; placebo = 4). Appendicular skeletal muscle mass (p = 0.004), appendicular skeletal muscle index (p = 0.004), phase angle (p = 0.014), and left arm circumference (p = 0.033) showed better results for the MSCs group compared to the placebo group between two and four months. The same occurred for HGS (p = 0.009). TUG (p = 0.039) showed improvement for both groups between two and four months. There was no difference in the diagnosis of sarcopenia between the groups. No correlation was found between cytokine dosage, viral load, CRP, and ferritin in the occurrence of sarcopenia. Myosteatosis was present in most patients. <bold>Conclusion</bold>: MSCs infusion positively impacted the recovery of muscle mass and strength after severe COVID-19 in patients admitted to the ICU in the critical phase of the disease. <bold>Trial registration</bold> This clinical trial was registered at the Brazilian Registry of Clinical Trials (ReBEC), UTN code U111112549819, on October 31, 2020 (retrospectively registered) (https//ensaiosclinicos.gov.br/rg/ RBR3fz9 year).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.020 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".