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Objective | pain | Academic Editor: Vahid Rakhshan This study aimed to compare the efficacy of manual therapy and pressure biofeedback-guided DCFM strength training on pain intensity and functional limitations in individuals with CGH. | PMC10442171 | |
Methods | headache disability | After applying the eligibility criteria, sixty out of eighty-nine CGH patients were recruited from King Saud University Medical Center in Riyadh and randomly allocated to intervention groups using simple random sampling. Group 1 underwent pressure biofeedback-guided DCFM strength training and conventional treatment, w... | PMC10442171 | |
Results | Sixty out of eighty participants aged 29–40 years were randomized into intervention groups ( | PMC10442171 | ||
Conclusion | pain | Compared with manual therapy, pressure biofeedback-guided DCFM strength training showed a greater reduction in pain intensity (assessed using the VAS) at weeks two and three. However, both treatments were equally effective in lowering headache-related functional limitations in patients with CGH. This trial is register... | PMC10442171 | |
1. Introduction | Headache, headaches, CGH, pain, ache, debilitating illness, tension-type, neck pain, cognitive pain | CERVICOGENIC HEADACHE, PATHOPHYSIOLOGY, CERVICOGENIC HEADACHES, HYPERSENSITIVITY, HEAT, CERVICOGENIC HEADACHE, COLD | Cervicogenic headache (CGH) is unilateral pain that starts in the neck and is referred from bony structures or soft tissues of the neck. It is a common and severe debilitating illness that primarily affects adult females; however, it affects both sexes aged between 20 and 60 years [The cervicogenic headache pathophysio... | PMC10442171 |
2. Materials and Methods | PMC10442171 | |||
2.1. Study Design | pain | This study followed a double-blinded, two-arm, parallel-group, multiple-timeline, randomized comparative design to test and compare the impact of manual therapy and pressure biofeedback-guided DCFM strength training on the outcomes of pain and functional limitations in individuals with CGH. | PMC10442171 | |
2.2. Ethical Considerations | The Ethics Committee of King Saud University approved this study (file ID: RRC-2022-04, dated: February 14, 2022), ensuring the protection of human and ethical rights in research involving human subjects. The study completed trial registration with ClinicalTrial.gov PRS (Identifier ID: | PMC10442171 | ||
2.3. Sample Size | A computer program G | PMC10442171 | ||
2.4. Study Setting | neck discomfort/pain | Sixty participants diagnosed with CGH by a consultant neurological physician were referred to the University Medical Center's outpatient physiotherapy department (OPD) for neck discomfort/pain treatment. The study was completed from February to September, 2022. Handy pamphlets, posters, and large banners were used in a... | PMC10442171 | |
2.5. Study Participants | TMJ dysfunction, headaches, vertigo, awkward head positioning, head pain, visual disturbance, stenosis | PROLAPSED DISC, STENOSIS | Sixty participants were recruited for the study based on the inclusion and exclusion criteria. The inclusion criteria were as follows: the participants exhibited unilateral head pain without side shift or bilateral head pain with a dominant side that hurts more than the other side, sustained awkward head positioning, a... | PMC10442171 |
2.6. Procedures | During seven-month screenings based on this study's inclusion and exclusion criteria, sixty participants were recruited and randomly assigned to groups 1 and 2 using simple random sampling. The participants' serial numbers were assigned equally to both groups using an online, website-based randomization program ( | PMC10442171 | ||
2.7. Outcome Measures | chronic pain, headaches, pain | CHRONIC PAIN | The participants' pain intensity was measured on a 10-cm visual analog scale (VAS) with zero (0) at one end and ten (10) at the other, signifying no pain and the worst pain possible, respectively. The participants were instructed to place a mark between 0 and 10 on the VAS scale to indicate their actual amount of pain ... | PMC10442171 |
2.8. Intervention | HEAT | Both groups 1 and 2 commonly received conventional treatment (i.e., moist heat pads). Group 1 performed pressure biofeedback-guided DCFM strength training, while Group 2 received manual therapy. | PMC10442171 | |
2.8.1. Pressure Biofeedback-Guided DCFM Strength Training | Participants from Group 1 performed the DCFM strength training exercise described by Jull [ | PMC10442171 | ||
2.8.2. Manual Therapy | A slow, sustained elongation of muscles [ | PMC10442171 | ||
2.8.3. Conventional Intervention | The participants received hot water fomentation applied over the shoulder and neck region in a long sitting position for fifteen minutes per session, five days a week for four weeks [ | PMC10442171 | ||
2.9. Statistical Analysis | Statistical Package for the Social Sciences (SPSS) software was used to analyze the data (IBM SPSS v.26, IBM Corp., Armonk, NY: USA). The Shapiro‒Wilk test is used to examine the distributional homogeneity of a sample. For the study of categorical data, the chi-square test was utilized. One-way analysis of variance (AN... | PMC10442171 | ||
3. Result | pain | Sixty (females, 33; males, 27; mean age, 34.95 years) out of eighty-nine participants with chronic mechanical pain diagnosed with CGH were randomly allocated to either group ( | PMC10442171 | |
3.1. Within-Group Analysis | The within-group analysis for the variables VAS and HDI revealed a statistically significant improvement (95% CI, In group 1, the VAS scores showed a significant mean difference (∆MD) when baseline was compared with the postintervention scores at different time intervals, such as VAS0-VAS1 (∆Furthermore, in group 1, th... | PMC10442171 | ||
3.2. Between-Group Analysis | Nevertheless, between-group (1 vs. 2) analysis of VAS and HDI outcomes revealed nonsignificant (95% CI, Furthermore, Cohen's | PMC10442171 | ||
4. Discussion | TrPs, headaches, head posture, pain, tension-type, headache, cognitive pain | CERVICOGENIC HEADACHE, CERVICOGENIC HEADACHES, HYPERSENSITIVITY, CCF | This study compared the efficacy of pressure biofeedback-guided DCFM strength training to cervical isometric exercises on pain and functional limitation in patients with cervicogenic headaches. The results of the study indicate that DCFM strength training using pressure biofeedback was more effective at reducing pain i... | PMC10442171 |
4.1. Limitations | pain | Despite its benefits, this study also had limitations. This study compared a manual therapy (single intervention approach) with a conventional intervention to alleviate the symptoms of patients with CGH. However, comparing a multimodal approach with a conventional intervention to manage the symptoms would have been an ... | PMC10442171 | |
5. Conclusion | pain | Compared with manual therapy, pressure biofeedback-guided DCFM strength training showed a greater reduction in pain intensity (VAS) at weeks two and three. However, both treatments were equally effective in lowering headache-related functional limitations in patients with CGH. While managing patients with CGH, the phys... | PMC10442171 | |
Acknowledgments | The authors are grateful to the Researchers Supporting Project number RSP2023R382, King Saud University, Riyadh, Saudi Arabia, for funding this research. | PMC10442171 | ||
Data Availability | The dataset for the results of this study will be available from the corresponding author upon reasonable request. | PMC10442171 | ||
Consent | Informed consent was obtained from all subjects involved in the study. | PMC10442171 | ||
Conflicts of Interest | The authors declare that there are no conflicts of interest. | PMC10442171 | ||
Authors' Contributions | headache disability | Shahnaz Hasan and Abeer R. Ibrahim conceptualized the study; Shahnaz Hasan, Abeer R. Ibrahim, Naiyer Shahzad, and Nasrin Bharti curated the data; AMIR IQBAL and Naiyer Shahzad formally analyzed the study; Ahmad H. Alghadir acquired the funding; Shahnaz Hasan, AMIR IQBAL, Ahmad H. Alghadir, Abeer R. Ibrahim, and Nasrin ... | PMC10442171 | |
Background: | Human social behavior | Human social behavior is modulated by oxytocin (OT). Intranasal administration of OT (IN-OT) is a noninvasive route shown to elicit changes in the autonomic nervous system (ANS) activity; however, IN-OT’s effect on the temporal profile of ANS activity at rest is yet to be described. | PMC10291383 | |
Aims: | We aimed to describe the temporal profile of IN-OT at six 10-min time windows from 15- to 100-min post-administration in 20 male participants at rest while continuously recording their pupillary in an eyes-open condition and cardiac activity in eyes-open and eyes-closed conditions. | PMC10291383 | ||
Methods: | We used a double-blind, placebo-controlled, within-subjects design study where we extracted two proxies of parasympathetic nervous system (PNS) activity: high-frequency heart rate variability (HF-HRV) and pupillary unrest index (PUI); and a proxy of sympathetic nervous system activity: sample entropy of the pupillary u... | PMC10291383 | ||
Results: | In the eyes-open condition, we found an effect of IN-OT on the proxies of PNS activity: decreased PUI in the three-time windows post-administration spanning 65–100 min, and as an exploratory finding, an increased HF-HRV in the 80–85 min time window. | PMC10291383 | ||
Conclusions: | alertness | We suggest there is a role of OT in PNS regulation that may be consistent with OT’s currently theorized role in the facilitation of alertness and approach behavior. | PMC10291383 | |
Introduction | CONSTRICTION, DILATION | Oxytocin (OT) has increasingly gathered the interest of cognitive neuroscientists since it was shown to be implicated in social cognition and behavior in humans (The effects of OT on social cognition have been linked to both central and peripherally measured nervous system activity and integrated into hypotheses such a... | PMC10291383 | |
Materials and methods | PMC10291383 | |||
Participants | We recruited 20 young ( | PMC10291383 | ||
Experimental procedure | The experimental session took place in a quiet room of the CAML’s Clinical Research Centre (Centro para Investigação Clínica) at the Hospital de Santa Maria, Lisbon, Portugal. We used a double-blind (throughout data collection up to statistical analysis, inclusive), randomized placebo-controlled, cross-over design, whe... | PMC10291383 | ||
Data acquisition and preprocessing | PMC10291383 | |||
Pupillary activity | blinks, partial occlusion of the eyelids | Participants sat comfortably with their chin supported over a chinrest to minimize head movement, at approximately 56 cm away from a Lenovo 23.8-inch screen with 1920 × 1080 resolution and 60 Hz refresh rate. At a 1000 Hz sampling rate, monocular gaze tracking and pupil size of the left eye of every participant were re... | PMC10291383 | |
Heart rate variability | The HRV was measured using a BIOPAC MP150 amplifier with the ECG recording module ECG100C-MRI in R wave at 1000 Hz sampling rate, gain as 1000, LP as 35 Hz and HP as 1 Hz (Biopac Systems Inc., Goleta, CA, USA) and AcqKnowledge 4.3 software. Three Ag/AgCl electrodes with 11-mm diameter (EL503 EKG , Biopac Systems Inc., ... | PMC10291383 | ||
Statistical analysis | Statistical analysis was performed in R software 3.6 ( | PMC10291383 | ||
Results | PMC10291383 | |||
Heart rate variability | PMC10291383 | |||
Eyes-closed | The main effect of drug on HF-HRV in eyes-closed, Profile of HF-HRV after IN-OT in a resting-state paradigm with eyes-closed (left) and eyes-open (right) conditions. Significant pairwise comparisons (IN-OT vs placebo) at specific time windows are marked with an asterisk (*). Eyes-closed time windows: 1 = 15–20 min; 2 =... | PMC10291383 | ||
Eyes-open | The main effect of drug on HF-HRV in eyes-open, | PMC10291383 | ||
Pupillary unrest (PUI and SampEn) | The main effect of drug on PUI was significant, Profile of two pupil size measures after IN-OT: PUI and SampEn; in a resting-state paradigm. Significant pairwise comparisons (IN-OT vs placebo) at specific time windows are marked with an asterisk (*). Time windows: 1 = 20–25 min; 2 = 35–40 min; 3 = 50–55 min; 4 = 65–70 ... | PMC10291383 | ||
Behavioral and Mood scales | The main effect of drug on excitability, | PMC10291383 | ||
Discussion | In this study, we aimed, for the first time, to our knowledge, to describe the temporal profile of 24 IU of IN-OT on ANS activity at rest. We included eyes-closed and eyes-open conditions and multiple time windows across a typically large neuroscience experiment duration (including a baseline assessment prior to drug a... | PMC10291383 | ||
The temporal profile of IN-OT effects | As abovementioned, the IN-OT effects we found both on pupillary unrest (at 65–100 min), and the exploratory finding on HF-HRV (at 80–85 min), were detected later than 40 min. Forty minutes is the starting time point which most previous studies have investigated ( | PMC10291383 | ||
IN-OT decreased PUI at rest: (Unexpectedly) suggestive of PNS | sleepiness, alertness, drowsiness | Our finding of IN-OT having an effect on pupil size at rest, that is, a medium-sized (On the other hand, and more substantially supported by previous evidence, PUI also increases with sleepiness and drowsiness and decreases with alertness (While PUI’s direct association with each branch of the ANS has not yet been rese... | PMC10291383 | |
Limitations | DRUG EFFECT | Herein we computed the Euclidean distance from each sample’s location to the center of the screen (i.e., fixation cross) and subjected this measure to the same statistical analysis of our dependent variables—to assess a, by chance, possible confounding effect of the pupil foreshortening error on our drug effect analyse... | PMC10291383 | |
Conclusions | alertness | We report herein on the temporal profile of IN-OT in the human ANS at rest using HRV and, for the first time, pupillary unrest measures. Having found OT to decrease PUI (suggesting PNS deactivation) and tentatively (as an exploratory finding) that it may increase HF-HRV (suggesting PNS activation), we speculated that b... | PMC10291383 | |
Supplemental Material | PMC10291383 | |||
References | PMC10291383 | |||
Purpose | Carboxymethylcellulose is an artificial tear ingredient known to decrease gut microbiome diversity when ingested. This study examines the effect of carboxymethylcellulose on ocular surface microbiome diversity and composition. | PMC10424155 | ||
Methods | DISEASE, DISEASE | Healthy adult participants without significant ophthalmic disease or concurrent carboxymethylcellulose artificial tear use were allocated randomly to take carboxymethylcellulose or control polyethylene glycol artificial tears for seven days. Conjunctival swabs were collected before and after artificial tear treatment. ... | PMC10424155 | |
Results | Of the 80 enrolled participants, 66 completed the trial. Neither intervention affected Chao-1 richness (analysis of variance [ANOVA], | PMC10424155 | ||
Conclusions | Carboxymethylcellulose artificial tears increased | PMC10424155 | ||
Translational Relevance | The 16S microbiome analysis has revealed small changes in the ocular surface microbiome associated with artificial tear use. | PMC10424155 | ||
Introduction | disorder of the ocular surface, Dry eye syndrome | PATHOPHYSIOLOGY, DRY EYE SYNDROME | Dry eye syndrome (DES) is a disorder of the ocular surface, frequently characterized by lipid or aqueous deficiency of the tear film.One potential factor mediating the inflammatory pathophysiology of DES is the ocular surface microbiome (OSM), composed of all microbial flora colonizing the ocular surface.Artificial tea... | PMC10424155 |
Methods | PMC10424155 | |||
Patients and Study Design | This is a double-masked randomized controlled trial (Study design and participant flow chart. After 96 prospective participants were assessed for eligibility, 80 participants were enrolled. Patients were assigned by simple randomization to receive either CMC or PEG ATs, masked to the participant and the researcher. Con... | PMC10424155 | ||
Intervention and Outcomes | DRY EYE | Enrolled participants were randomized to receive either ATs containing 0.5% CMC (Refresh Plus; Allergan Inc., Dublin, Ireland) or control ATs containing 0.4% PEG (Systane PF; Alcon Labs, Fort Worth, TX, USA). For the purposes of masking, one researcher with no participant contact (Li, Y.) created 80 identical boxes, ea... | PMC10424155 | |
Ocular Surface Microbiome Sample Collection and Processing | STERILE, LYSIS | Before each conjunctival swab, one drop of proparacaine was instilled in both eyes. A sterile solid-core nylon swab (DNA/RNA Shield Swab collection kit; Zymo, Orange, CA, USA) was rotated in the inferior fornix of the left eye, then the right eye, and placed into a bead-beating tube containing 750 µL DNeasy lysis buffe... | PMC10424155 | |
Data Processing and Statistical Analysis | Raw MiSeq reads (covering the V1–V3 hypervariable region of the 16S rRNA gene using primers 27F and 534R) were demultiplexed using cutadapt4. | PMC10424155 | ||
Results | OCULAR SURFACE DISEASE, COMPLICATIONS | Among the 80 participants enrolled, 35 participants in the CMC group completed the follow-up period, and 31 participants in the PEG group completed the follow-up period. No intervention-associated complications were observed, and both interventions were well tolerated. Participant characteristics are displayed in the P... | PMC10424155 | |
Discussion | To our knowledge, this is the first randomized double-masked clinical trial assessing the effect of CMC-ATs on the OSM. Existing studies comparing AT formulations found minimal differences in subjective and objective outcomes among over-the-counter ATs but have yet to examine implications for the OSM. | PMC10424155 | ||
Participants, Compliance, and Dry Eye Symptoms | Participants who completed the study were healthy adults without significant comorbidities, and there were no significant differences in the demographics of both study arms (On enrollment, both study arms had comparable DES symptomatology, with OSDI scores less than 22 in 60 participants (90.1%). Therefore only the rem... | PMC10424155 | ||
OSM Diversity | SEPARATION | When examining OSM diversity, several measures have been reported in the literature.Similar Chao-1 estimates and Shannon diversities between the CMC and PEG study arms and time points (Overall, it appears that the high microbial diversity associated with DES may be resilient to topical elution or short-term interventio... | PMC10424155 | |
OSM Composition | Before the advent of metagenomic analysis using bacterial ribosomal RNA high-throughput sequencing, the ocular surface was thought to have low bacterial abundance and diversity dominated by onfallen skin flora.In our participants, we found high relative abundances of To identify differentially abundant taxa between gro... | PMC10424155 | ||
Study Limitations | Interpretation of this study should consider that AT compliance was participant-reported and not actively monitored (i.e., checking empty vials) as other studies have done.Although the objective of this study was to identify effects of CMC on the OSM, neither pure CMC solution nor a perfect control were available. Inst... | PMC10424155 | ||
Conclusion | In this double-masked randomized controlled trial, CMC AT treatment increased | PMC10424155 | ||
Acknowledgments | Supported in part by NIAID R21 AI150250, VA CSR&D Merit Review I01CX001391, and the Gatorade Trust through funds distributed by the University of Florida, Department of Medicine. The funding organization had no role in the design or conduct of this research.Disclosure: | PMC10424155 | ||
References | PMC10424155 | |||
Introduction | deficiencies of the hematopoietic system, herpes virus specific T cells, hematologic malignancies, immunodeficiency of the host | DISEASE, HEMATOLOGIC MALIGNANCIES | Edited by: Christian Muenz, University of Zurich, SwitzerlandReviewed by: Enrico Maffini, University of Bologna, Italy; Maria Teresa Lupo Stanghellini, Scientific Institute for Research, Hospitalization and Healthcare (IRCCS), ItalyAllogeneic stem cell transplantation is used to cure hematologic malignancies or deficie... | PMC10642256 |
Methods | TRANSFUSION REACTION | We report the results of a randomized controlled multi centre phase I/IIa study (MULTIVIR-01) using a newly developed T cell product with specificity for CMV and EBV derived from the allogeneic stem cell grafts used for transplantation. The study aimed at prevention and preemptive treatment of both viruses in patients ... | PMC10642256 | |
Results | ADVERSE EVENTS, VIRUS, GRAFT VERSUS HOST DISEASE | Thirty-three patients were screened and 9 patients were treated with a total of 25 doses of the T cell product. We show that central manufacturing can be achieved successfully under study conditions and the product can be applied without major side effects. Overall survival, transplant related mortality, cumulative inc... | PMC10642256 | |
Discussion | ACUTE GRAFT VERSUS HOST DISEASE | Our study results indicate peptide stimulated epitope specific T cells derived from stem cell grafts can be administered safely for prevention and preemptive treatment of reactivation without evidence for induction of acute graft versus host disease. | PMC10642256 | |
Clinical trial registration | PMC10642256 | |||
Introduction | deficiencies of the hematopoietic system, toxicity, GvHD, Epstein-Barr virus, EBV infections, infection, malignant diseases, latent-, herpesvirus reactivations | CYTOMEGALOVIRUS, GRAFT-VERSUS-HOST DISEASE, COMPLICATION, MALIGNANT DISEASE, INFECTION, EBV INFECTION | Allogeneic stem cell transplantation (aSCT) in the adult patient aims at curing malignant diseases or other deficiencies of the hematopoietic system. Aside from graft-versus-host disease (GvHD), reactivation of latent herpesviruses represents a major complication significantly contributing to morbidity and impairment o... | PMC10642256 |
Patients and methods | PMC10642256 | |||
Study design/protocol | comorbidity, MM, toxicity, SIB, AML, MPS, ALL, Non-Hodgkin-lymphoma, COPD, NHL | MULTIPLE MYELOMA, ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME, AML, ACUTE LYMPHOBLASTIC LEUKEMIA, COPD, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, MYELOPROLIFERATIVE SYNDROME, NHL, ONCOLOGY, TRANSFUSION REACTION | This controlled, randomized, open label, multicenter phase I/IIa trial exploring the safety and efficacy of allogeneic donor-derived peptide-stimulated T cells with specificity for CMV and EBV in a preventative/pre-emptive setting in patients after aSCT was approved by the federal authority Paul Ehrlich Institute (No. ... | PMC10642256 |
Patient cohort | Major inclusion and exclusion criteria are shown in Prevalence of required HLA class I loci among patients screened. Peptides chosen for stimulation required the presence of distinct HLA class I loci. | PMC10642256 | ||
Manufacturing of T cell product | The manufacturing process (approval number by Government of Oberfranken (DE_BY_05_MIA_2014_0045/55.2-2678.3-6-1) for the T cell product has been described previously (Peptides used for HLA multimer analysis of virus-specific CD8+ T cells.To assess the presence of CMV/EBV specific CD8+ T cells before and after the T cel... | PMC10642256 | ||
Flow cytometric analysis | APC | All antibodies were purchased from BD Biosciences (Heidelberg, Germany) unless otherwise specified. For phenotypic analysis, cells were stained with anti-CD8 FITC (clone SK1), anti-CD25 PE (clone 2A3), anti-CD14 PerCP (clone MφP9), anti-CD56 APC (clone B159), anti-CD19 PE-Cy7 (clone SJ25C1), anti-CD4 APC-Cy7 (clone RPA... | PMC10642256 | |
Statistical analysis | Statistical analysis was performed using IBM SPSS software Version 28. Survival curves were generated using Kaplan-Meyer estimates. Comparison of means was performed using a non parametric Mann-Whitney-U test. To test the frequency distribution of categorical variables a Chi Square test was used. For analysis of contin... | PMC10642256 | ||
Results | PMC10642256 | |||
Patients and recruitment | Over the study period from 2013 to 2019, 33 patients were screened and 29 patients were enrolled in to the study and randomized (see Inclusion into the study required the presence of at least one of the following HLA alleles: HLA-A*01:01, A*02:01, B*07:02, B*08:01, B*35:01, or C*07:02. | PMC10642256 | ||
Manufacturing of the T cell product | A total of 17 products were manufactured during the study period. Overview of T cell products manufactured.In total 17 products were generated throughout the study. Products transfused are highlighted in dark grey. Light grey indicates products not transfused. The table shows the absolute dosing and dosing/kg bodyweigh... | PMC10642256 | ||
Application of the T cell product | As this study aimed at prevention and pre-emptive treatment of reactivation of CMV and EBV the dose schedule was planned to start as early as day 30 post aSCT. A total of 3 equal doses was planned for each patient with consecutive doses on days 30, 60, and 90 while patients were still receiving cyclosporine A. The targ... | PMC10642256 | ||
Adverse events | ADVERSE EVENTS, EVENTS | We observed in total 618 adverse events (AE) in both groups with an average of 24.7 ± 17.2 per patient. As shown in Events during study.Number of AE, SAE, medical treatments, and hospitalizations in both groups. There was no statistical difference between both groups regarding all adverse observations (non-parametric M... | PMC10642256 | |
Outcomes | The study recruited patients from 2013 until the end of 2018. The database was closed on 31Outcomes. Database was closed on Dec 31 | PMC10642256 | ||
Study endpoints | toxicity | EVENTS, TRANSFUSION REACTION | The primary endpoint of this first-in-human study was toxicity assessed by the incidence of acute transfusion reaction related to the T cell product and/or late toxicity manifested by the development of acute GvHD due to the infusion of activated T cells. As shown previously, the T-cell products can substantially expan... | PMC10642256 |
T cell reconstitution | SECONDARY | As a secondary endpoint, T cell reconstitution was compared between the two groups at equivalent time points, starting before the first infusion of the T cell product. An example of flow cytometric analysis of peripheral blood is shown in T cell reconstitution during study treatment. Patients (n=9) randomized into trea... | PMC10642256 | |
Discussion | toxicity | RECRUITMENT, VIRUS, DISEASE, RECRUITMENT, SECONDARY, TRANSFUSION REACTION, TRANSFUSION REACTIONS | In this paper we present the results of a randomized controlled phase I/IIa study (MULTIVIR-01) aiming at prevention or pre-emptive treatment of CMV/EBV viral reactivation in patients after aSCT. Patients received 3 consecutive doses of 21,000-41,000 CD3+ T cells per kg bodyweight and dose, separated by 2 intervals of ... | PMC10642256 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10642256 | ||
Ethics statement | The studies involving humans were approved by Institutional Review Board of the University Hospital Erlangen (306_13 Az). The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study. | PMC10642256 | ||
Author contributions | AG: Designed study, wrote study protocol, developed cell product and manufacturing protocol, wrote IB, recruited patients, analyzed data, generated figures, wrote manuscript. RG: Developed manufacturing protocol, wrote IB, performed quality analysis of the cell product, performed manufacturing, analyzed data, generated... | PMC10642256 | ||
Acknowledgments | We would like to thank all patients participating in this study. Especially we would like to thank members of the study teams at all participating centers for their excellent work. Many thanks go to the excellent study monitors provided by the Center for Clinical Studies CCS and the support from the IT department of th... | PMC10642256 |
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