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Stem Cell Research & Therapy Jun 2024The aim of this study is to systematically review randomized controlled clinical trials (RCTs) studying various types of regenerative medicine methods (such as...
AIMS AND OBJECTIVES
The aim of this study is to systematically review randomized controlled clinical trials (RCTs) studying various types of regenerative medicine methods (such as platelet-rich plasma, stromal vascular fraction, cell therapy, conditioned media, etc.) in treating specific dermatologic diseases. Rejuvenation, scarring, wound healing, and other secondary conditions of skin damage were not investigated in this study.
METHOD
Major databases, including PubMed, Scopus, and Web of Science, were meticulously searched for RCTs up to January 2024, focusing on regenerative medicine interventions for specific dermatologic disorders (such as androgenetic alopecia, vitiligo, alopecia areata, etc.). Key data extracted encompassed participant characteristics and sample sizes, types of regenerative therapy, treatment efficacy, and adverse events.
RESULTS
In this systematic review, 64 studies involving a total of 2888 patients were examined. Women constituted 44.8% of the study population, while men made up 55.2% of the participants, with an average age of 27.64 years. The most frequently studied skin diseases were androgenetic alopecia (AGA) (45.3%) and vitiligo (31.2%). The most common regenerative methods investigated for these diseases were PRP and the transplantation of autologous epidermal melanocyte/keratinocyte cells, respectively. Studies reported up to 68.4% improvement in AGA and up to 71% improvement in vitiligo. Other diseases included in the review were alopecia areata, melasma, lichen sclerosus et atrophicus (LSA), inflammatory acne vulgaris, chronic telogen effluvium, erosive oral lichen planus, and dystrophic epidermolysis bullosa. Regenerative medicine was found to be an effective treatment option in all of these studies, along with other methods. The regenerative medicine techniques investigated in this study comprised the transplantation of autologous epidermal melanocyte/keratinocyte cells, isolated melanocyte transplantation, cell transplantation from hair follicle origins, melanocyte-keratinocyte suspension in PRP, conditioned media injection, a combination of PRP and basic fibroblast growth factor, intravenous injection of mesenchymal stem cells, concentrated growth factor, stromal vascular fraction (SVF), a combination of PRP and SVF, and preserving hair grafts in PRP.
CONCLUSION
Regenerative medicine holds promise as a treatment for specific dermatologic disorders. To validate our findings, it is recommended to conduct numerous clinical trials focusing on various skin conditions. In our study, we did not explore secondary skin lesions like scars or ulcers. Therefore, assessing the effectiveness of this treatment method for addressing these conditions would necessitate a separate study.
Topics: Adult; Female; Humans; Male; Platelet-Rich Plasma; Randomized Controlled Trials as Topic; Regenerative Medicine; Skin Diseases
PubMed: 38886861
DOI: 10.1186/s13287-024-03800-6 -
Perioperative Medicine (London, England) Jun 2024The purpose of the current study was to assess the efficacy of tranexamic acid (TXA) on reducing bleeding in cardiac surgical patients with preoperative antiplatelet... (Review)
Review
BACKGROUND
The purpose of the current study was to assess the efficacy of tranexamic acid (TXA) on reducing bleeding in cardiac surgical patients with preoperative antiplatelet therapy (APT).
METHODS
Five electronic databases were searched systematically for randomized-controlled trials (RCTs) assessing the impact of intravenous TXA on post-operative bleeding on cardiac surgical patients with preoperative APT until May 2024. Primary outcome of interest was post-operative blood loss. Secondary outcomes of interest included the incidence of reoperation due to post-operative bleeding, post-operative transfusion requirements of red blood cells (RBC), fresh-frozen plasma (FFP), and platelet concentrates. Mean difference (MD) with 95% confidence interval (CI) or odds ratios (OR) with 95% CI was employed to analyze the data. Subgroup and meta-regression analyses were performed to assess the possible influence of TXA administration on reducing bleeding and transfusion requirements.
RESULTS
A total of 12 RCTs with 3018 adult cardiac surgical patients (TXA group, 1510 patients; Control group, 1508 patients) were included. The current study demonstrated that TXA significantly reduced post-operative blood loss (MD = - 0.38 L, 95% CI: - 0.73 to - 0.03, P = 0.03; MD = - 0.26 L, 95% CI: - 0.28 to - 0.24, P < 0.00001; MD = - 0.37 L, 95% CI: - 0.63 to - 0.10, P = 0.007) in patients receiving dual antiplatelet therapy (DAPT), aspirin, or clopidogrel, respectively. Patients in TXA group had significantly lower incidence of reoperation for bleeding as compared to those in Control group. The post-operative transfusion of RBC and FFP requirements was significantly lower in TXA group than Control group. Subgroup analyses showed that studies with DAPT discontinued on the day of surgery significantly increased the risk of post-operative blood loss [(MD: - 1.23 L; 95% CI: - 1.42 to - 1.04) vs. (MD: - 0.16 L; 95% CI: - 0.27 to - 0.05); P < 0.00001 for subgroup difference] and RBC transfusion [(MD: - 3.90 units; 95% CI: - 4.75 to - 3.05) vs. (MD: - 1.03 units; 95% CI: - 1.96 to - 0.10); P < 0.00001 for subgroup difference] than those with DAPT discontinued less than 5-7 days preoperatively.
CONCLUSIONS
This meta-analysis demonstrated that TXA significantly reduced post-operative blood loss and transfusion requirements for cardiac surgical patients with preoperative APT. These potential clinical benefits may be greater in patients with aspirin and clopidogrel continued closer to the day of surgery.
TRIAL REGISTRATION NUMBER
CRD42022309427.
PubMed: 38886771
DOI: 10.1186/s13741-024-00418-3 -
Journal of ISAKOS : Joint Disorders &... Jun 2024Orthobiologics has seen a renaissance over the last decade as an adjunct therapy during osteotomy due to the limited inherent regenerative potential of damaged... (Review)
Review
IMPORTANCE
Orthobiologics has seen a renaissance over the last decade as an adjunct therapy during osteotomy due to the limited inherent regenerative potential of damaged intraarticular tissues.
AIM OR OBJECTIVE
This systematic review aims to present the latest evidence regarding using orthobiologics with simultaneous high tibial osteotomy (HTO) for knee osteoarthritis. The results of this study may guide surgeons to improve their clinical results and clear the air regarding confusion over whether or not to add orthobiologics to HTO in clinical practice backed by scientific evidence.
EVIDENCE REVIEW
According to PRISMA guidelines a systematic search for relevant literature was performed in the PubMed (MEDLINE), Scopus, EMBASE, and Cochrane Library databases of all studies published in English from January 1990 to May 2023. The following search terms were entered into the title, abstract, and keyword fields: "knee" or "osteotomy" AND "valgus" or "varus" AND "regenerative medicine" or "PRP" or "mesenchymal stem cells" or "stem cells" or "BMAC" or "bone marrow" or "growth factors" or "umbilical cord blood-derived mesenchymal stem cell" or "stromal vascular fraction". The AMSTAR-2 checklist was used to confirm the quality of the systematic review. Randomised controlled trials (RCTs), prospective and retrospective comparative cohort studies, case-control studies, and case series were included. Studies that reported clinical outcomes in patients treated with knee osteotomy for varus/valgus knee with concomitant adjunction of regenerative treatment [Platelet-rich plasma (PRP), Adipose-derived stem cells (ADSC), Human Umbilical Cord Blood-Derived (HUCBD), Mesenchymal Stem Cells (MSC), bone marrow aspirate concentrate (BMAC), stromal vascular fraction (SVF)] were included. The outcome measures extracted from the studies were the KOOS score, Lysholm score, Subjective IKDC, WOMAC Score, KSS, Tegner, HSS, radiographic tibiofemoral angle, posterior tibial slope and complications. The current systematic review is registered in the PROSPERO Registry (CRD42023439379).
FINDINGS
Osteotomy for unicompartmental arthritis with adjunction of orthobiologics such as PRP, ADSC, HUCBD, MSC, BMAC, and SVF presents a consistent statistically significant clinical improvement compared to preoperative scores regardless of the treatment modality used and there were no notable complications associated with the use of these novel agents.
CONCLUSIONS AND RELEVANCE
Orthobiologics and knee osteotomies could improve outcomes in patients with knee osteoarthritis desiring Knee preservation surgeries. However, only a few studies are available on the topic to conclude anything with certainty, the patients included in the studies could not be disintegrated based on the grade of osteoarthritis (OA), type, dosage and frequency of administration of orthobiologic and type of additional surgical procedures used. Therefore, better-structured RCTs are required to implement this finding into routine Orthopaedic practice.
LEVEL OF EVIDENCE
Level 4.
PubMed: 38851324
DOI: 10.1016/j.jisako.2024.06.001 -
Frontiers in Aging Neuroscience 2024Soluble triggering receptor expressed on myeloid cells 2 (sTREM2) is a potential neuroinflammatory biomarker linked to the pathogenesis of Alzheimer's disease (AD) and...
OBJECTIVE
Soluble triggering receptor expressed on myeloid cells 2 (sTREM2) is a potential neuroinflammatory biomarker linked to the pathogenesis of Alzheimer's disease (AD) and mild cognitive impairment (MCI). Previous studies have produced inconsistent results regarding sTREM2 levels in various clinical stages of AD. This study aims to establish the correlation between sTREM2 levels and AD progression through a meta-analysis of sTREM2 levels in cerebrospinal fluid (CSF) and blood.
METHODS
Comprehensive searches were conducted in PubMed, Embase, Web of Science, and the Cochrane Library to identify observational studies reporting CSF and blood sTREM2 levels in AD patients, MCI patients, and healthy controls. A random effects meta-analysis was used to calculate the standardized mean difference (SMD) and 95% confidence intervals (CIs).
RESULTS
Thirty-six observational studies involving 3,016 AD patients, 3,533 MCI patients, and 4,510 healthy controls were included. CSF sTREM2 levels were significantly higher in both the AD [SMD = 0.28, 95% CI (0.15, 0.41)] and MCI groups [SMD = 0.30, 95% CI (0.13, 0.47)] compared to the healthy control group. However, no significant differences in expression were detected between the AD and MCI groups [SMD = 0.09, 95% CI (-0.09, 0.26)]. Furthermore, increased plasma sTREM2 levels were associated with a higher risk of AD [SMD = 0.42, 95% CI (0.01, 0.83)].
CONCLUSION
CSF sTREM2 levels are positively associated with an increased risk of AD and MCI. Plasma sTREM2 levels were notably higher in the AD group than in the control group and may serve as a promising biomarker for diagnosing AD. However, sTREM2 levels are not effective for distinguishing between different disease stages of AD. Further investigations are needed to explore the longitudinal changes in sTREM2 levels, particularly plasma sTREM2 levels, during AD progression.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024514593.
PubMed: 38841103
DOI: 10.3389/fnagi.2024.1407980 -
Gynecological Endocrinology : the... Dec 2024To compare the effectiveness of endometrial receptivity and pregnancy outcomes of four common immunomodulatory therapies for patients with thin endometrium. (Meta-Analysis)
Meta-Analysis
OBEJECTIVE
To compare the effectiveness of endometrial receptivity and pregnancy outcomes of four common immunomodulatory therapies for patients with thin endometrium.
METHOD
This systematic review and network meta-analysis using a literature search up to January 2024, to identify relevant trials comparing endometrial receptivity and pregnancy outcomes of human chorionic gonadotropin (hCG), platelet-rich plasma (PRP), infusion of granulocyte colony-stimulating factor (IG-CSF), and peripheral blood mononuclear cell (PBMC) for patients with thin endometrium. We used surface under the cumulative ranking (SUCRA) to ranked four common immunomodulatory therapies on endometrium thickness, implantation rate (IR), clinical pregnancy rate (CPR), and live birth rate (LBR). RoB2 and ROBINS-I were used to assess the certainty of evidence.
RESULTS
The pooled results of 22 studies showed that hCG (mean difference [MD]: 3.05, 95% confidence interval [CI]: 1.46-4.64) and PRP (MD: 0.98, 95% CI: 0.20-1.76) significantly increase endometrium thickness. The hCG was the best among the IG-CSF (MD = -2.56, 95% CI = -4.30 to -0.82), PBMC (MD = -2.75, 95% CI = -5.49 to -0.01), and PRP (MD = -2.07, 95% CI = -3.84 to -0.30) in increasing endometrium thickness. However, IG-CSF and PRP significantly improved IR (IG-CSF: risk ratio (RR; IG-CSF: RR = 1.33, 95% CI = 1.06-1.67; PRP: RR = 1.63, 95% CI = 1.19-2.23), and LBR (IG-CSF: RR = 1.53, 95% CI = 1.16-2.02; PRP: RR = 1.59, 95% CI = 1.08-2.36).
CONCLUSIONS
Available evidence reveals that hCG and subcutaneous or intrauterine CSF (SG-CSF) may be the best treatment options for current thin endometrium patients. However, future high-quality and large-scale studies are necessary to validate our findings.
Topics: Humans; Female; Endometrium; Pregnancy; Network Meta-Analysis; Chorionic Gonadotropin; Platelet-Rich Plasma; Granulocyte Colony-Stimulating Factor; Pregnancy Rate; Leukocytes, Mononuclear; Embryo Implantation
PubMed: 38835267
DOI: 10.1080/09513590.2024.2360072 -
JAMA Network Open Jun 2024Published research suggests that patient-reported outcomes (PROs) are neither commonly collected nor reported in randomized clinical trials (RCTs) for solid tumors....
IMPORTANCE
Published research suggests that patient-reported outcomes (PROs) are neither commonly collected nor reported in randomized clinical trials (RCTs) for solid tumors. Little is known about these practices in RCTs for hematological malignant neoplasms.
OBJECTIVE
To evaluate the prevalence of PROs as prespecified end points in RCTs of hematological malignant neoplasms, and to assess reporting of PROs in associated trial publications.
EVIDENCE REVIEW
All issues of 8 journals known for publishing high-impact RCTs (NEJM, Lancet, Lancet Hematology, Lancet Oncology, Journal of Clinical Oncology, Blood, JAMA, and JAMA Oncology) between January 1, 2018, and December 13, 2022, were searched for primary publications of therapeutic phase 3 trials for adults with hematological malignant neoplasms. Studies that evaluated pretransplant conditioning regimens, graft-vs-host disease treatment, or radiotherapy as experimental treatment were excluded. Data regarding trial characteristics and PROs were extracted from manuscripts and trial protocols. Univariable analyses assessed associations between trial characteristics and PRO collection or reporting.
FINDINGS
Ninety RCTs were eligible for analysis. PROs were an end point in 66 (73%) trials: in 1 trial (1%) as a primary end point, in 50 (56%) as a secondary end point, and in 15 (17%) as an exploratory end point. PRO data were reported in 26 of 66 primary publications (39%): outcomes were unchanged in 18 and improved in 8, with none reporting worse PROs with experimental treatment. Trials sponsored by for-profit entities were more likely to include PROs as an end point (49 of 55 [89%] vs 17 of 35 [49%]; P < .001) but were not significantly more likely to report PRO data (20 of 49 [41%] vs 6 of 17 [35%]; P = .69). Compared with trials involving lymphoma (18 of 29 [62%]) or leukemia or myelodysplastic syndrome (18 of 28 [64%]), those involving plasma cell disorders or multiple myeloma (27 of 30 [90%]) or myeloproliferative neoplasms (3 of 3 [100%]) were more likely to include PROs as an end point (P = .03). Similarly, compared with trials involving lymphoma (3 of 18 [17%]) or leukemia or myelodysplastic syndrome (5 of 18 [28%]), those involving plasma cell disorders or multiple myeloma (16 of 27 [59%]) or myeloproliferative neoplasms (2 of 3 [67%]) were more likely to report PROs in the primary publication (P = .01).
CONCLUSIONS AND RELEVANCE
In this systematic review, almost 3 of every 4 therapeutic RCTs for blood cancers collected PRO data; however, only 1 RCT included PROs as a primary end point. Moreover, most did not report resulting PRO data in the primary publication and when reported, PROs were either better or unchanged, raising concern for publication bias. This analysis suggests a critical gap in dissemination of data on the lived experiences of patients enrolled in RCTs for hematological malignant neoplasms.
Topics: Humans; Patient Reported Outcome Measures; Hematologic Neoplasms; Clinical Trials, Phase III as Topic; Randomized Controlled Trials as Topic
PubMed: 38829615
DOI: 10.1001/jamanetworkopen.2024.14425 -
Frontiers in Public Health 2024The timely diagnosis of tuberculosis through innovative biomarkers that do not rely on sputum samples is a primary focus for strategies aimed at eradicating... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The timely diagnosis of tuberculosis through innovative biomarkers that do not rely on sputum samples is a primary focus for strategies aimed at eradicating tuberculosis. miR-29 is an important regulator of tuberculosis pathogenesis. Its differential expression pattern in healthy, latent, and active people who develop tuberculosis has revealed its potential as a biomarker in recent studies. Therefore, a systematic review and meta-analysis were performed for the role of miR-29 in the diagnosis of tuberculosis.
METHODS
EMBASE, PubMed, CNKI, Web of Science, and Cochrane Library databases were searched utilizing predefined keywords for literature published from 2000 to February 2024.Included in the analysis were studies reporting on the accuracy of miR-29 in the diagnosis of tuberculosis, while articles assessing other small RNAs were not considered. All types of study designs, including case-control, cross-sectional, and cohort studies, were included, whether prospectively or retrospectively sampled, and the quality of included studies was determined utilizing the QUADAS-2 tool. Publication bias was analyzed via the construction of funnel plots. Heterogeneity among studies and summary results for specificity, sensitivity, and diagnostic odds ratio (DOR) are depicted in forest plots.
RESULTS
A total of 227 studies were acquired from the various databases, and 18 articles were selected for quantitative analysis. These articles encompassed a total of 2,825 subjects, primarily sourced from the Asian region. Patient specimens, including sputum, peripheral blood mononuclear cells, cerebrospinal fluid and serum/plasma samples, were collected upon admission and during hospitalization for tuberculosis testing. miR-29a had an overall sensitivity of 82% (95% CI 77, 85%) and an overall specificity of 82% (95% CI 78, 86%) for detecting tuberculosis. DOR was 21 (95% CI 16-28), and the area under the curve was 0.89 (95% CI 0.86, 0.91). miR-29a had slightly different diagnostic efficacy in different specimens. miR-29a showed good performance in both the diagnosis of pulmonary tuberculosis and extrapulmonary tuberculosis. miR-29b and miR-29c also had a good performance in diagnosis of tuberculosis.
CONCLUSION
As can be seen from the diagnostic performance of miR-29, miR-29 can be used as a potential biomarker for the rapid detection of tuberculosis.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=461107.
Topics: Humans; MicroRNAs; Biomarkers; Tuberculosis; Sensitivity and Specificity
PubMed: 38807999
DOI: 10.3389/fpubh.2024.1384510 -
PloS One 2024Spermatozoa cryopreservation has been practiced for decades and is a very useful technique for long-term preservation of sperm fertility. The capability for semen...
Spermatozoa cryopreservation has been practiced for decades and is a very useful technique for long-term preservation of sperm fertility. The capability for semen cryopreservation varies across species, seasons, latitudes, and even for different ejaculates from the same animal. This article summarizes research results on sperm cryotolerance biomarkers in several species, focusing on three areas: spermatozoa cryotolerance biomarkers, seminal plasma proteins cryotolerance biomarkers, and other cryotolerance biomarkers. We discovered that sperm cryoresistance biomarkers are primarily related to sperm plasma membrane stability, the presence of antioxidant substances in sperm or seminal plasma, sperm cell energy metabolism, water and small molecule transport channels in the sperm plasma membrane, and antistress substances in sperm or seminal plasma. The research conducted using diverse livestock models can be employed to enhance the basic and applied reproduction of other mammals through the study of sperm cryotolerance biomarkers, as well as the substantial similarities between livestock and other organisms, including endangered species.
Topics: Cryopreservation; Male; Biomarkers; Semen Preservation; Animals; Semen; Spermatozoa; Humans; Cell Membrane
PubMed: 38776323
DOI: 10.1371/journal.pone.0303567 -
Frontiers in Endocrinology 2024Thin endometrium (TE) is defined as a mid-luteal endometrial thickness ≤7mm. TE can affect endometrial tolerance, leading to lower embryo implantation rates and...
Thin endometrium (TE) is defined as a mid-luteal endometrial thickness ≤7mm. TE can affect endometrial tolerance, leading to lower embryo implantation rates and clinical pregnancy rates, and is also associated with impaired outcomes from assisted reproductive treatment. Herein, we systematically review TE causes, mechanisms, and treatments. TE pathogenesis has multiple causes, with the endometrium becoming thinner with age under hormonal influence. In addition, uterine cavity factors are important, as the inflammatory environment may affect expressions of certain genes thereby inhibiting endometrial stromal cell proliferation and promoting apoptosis. Long-term oral contraceptive use or the use of ovulation-promoting drugs are also definite factors contributing to endometrial thinning. Other patients have primary factors, for which the clinical etiology remains unknown. The main therapeutic strategies available for TE are pharmacological (including hormonal and vasoactive drugs), regenerative medicine, intrauterine infusion of growth factor-granulocyte colony-stimulating factor, autologous platelet-rich plasma, and complementary alternative therapies (including traditional Chinese herbal medicine and acupuncture). However, the associated mechanisms of action are currently unclear. Clinical scholars have proposed various approaches to improve treatment outcomes in patients with TE, and are exploring the principles of efficacy, offering potentials for novel treatments. It is hoped that this will improve TE tolerance, increase embryo implantation rates, and help more couples with infertility with effective treatments.
Topics: Female; Humans; Pregnancy; Embryo Implantation; Endometrium; Infertility, Female
PubMed: 38745960
DOI: 10.3389/fendo.2024.1269382 -
Cureus Apr 2024Sickle cell disease (SCD) is a group of inherited genetic disorders that is caused by a mutation in the gene that codes for hemoglobin subunit β. This systematic review... (Review)
Review
Sickle cell disease (SCD) is a group of inherited genetic disorders that is caused by a mutation in the gene that codes for hemoglobin subunit β. This systematic review aimed to evaluate the effect of folic acid in the treatment of SCD patients. We retrieved 3730 articles from PubMed, PubMed Central, Google Scholar, and ScienceDirect databases. We employed a search technique that involved framing keywords, such as folic acid, folate, and sickle cell illness, and the Medical Subject Headings (MeSH) strategy in PubMed. We chose research articles that had been published during the last 10 years, as well as case reports, systematic reviews and meta-analyses, literature reviews, randomized controlled trials, and observational studies. Exclusion criteria included paid full-text articles, abstracts, non-English studies, and patients who do not have SCD. The 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria were used in the design of our systematic review. It was found that the majority of SCD patients were receiving regular folic acid supplements and that their plasma folate levels were either increased or within normal range, with no discernible impact on other clinical outcomes such as hemoglobin levels, infections, or pain crises. SCD patients produce more red blood cells than healthy individuals, and nearly all SCD patients receive daily folic acid supplements. On the other hand, not enough information is available on folic acid's potential benefits in the management of SCD; thus, there is a need for more large clinical trials.
PubMed: 38738102
DOI: 10.7759/cureus.57962