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The journal of obstetrics and gynaecology research · 2026
Fetal nutrient supply depends on maternal status. Pregnant women tend to pay close attention to their health and diet, and micronutrient supplementation is widely practiced. Overweight and obese pregnant women exhibit altered metabolism, inflammation, and placental function. These may limit the efficacy of nutritional supplementation in this population. Robust evidence on supplement efficacy and safety in this high-risk group is lacking. To evaluate the effects of antenatal nutritional supplementation on perinatal outcomes in women with pre-pregnancy overweight or obesity, we conducted a systematic review and meta-analysis. We searched PubMed, Embase, and the Cochrane Library to 16 July 2025 for randomized controlled trials (RCTs) comparing any nutritional supplement versus placebo in pregnant women with body mass index (BMI) ≥ 25 kg/m2. Nineteen RCTs (3482 participants) were included; risk ratios (RR) with 95% confidence intervals (CI) were pooled using fixed- or random-effects models. Supplements did not alter birth weight (SMD 0.04; 95% CI -0.04 to 0.11) or overall cesarean section risk. Probiotic supplementation increased preterm birth risk by 86% (RR 1.86; 95% CI 1.09-3.18). Inositol reduced preterm birth (RR 0.28; 95% CI 0.13-0.64) and preeclampsia (RR 0.40; 95% CI 0.19-0.83). Unsaturated fatty acids lowered macrosomia incidence (RR 0.53; 95% CI 0.29-0.95). Routine unsaturated fatty acids and inositol supplementation should be considered for overweight or obese pregnant women to reduce macrosomia, preterm birth, preeclampsia, and gestational hypertension. Chronic or prophylactic probiotic supplementation is not recommended.
Human psychopharmacology · 2026
Impulsivity is a transdiagnostic risk factor for numerous health morbidities and is strongly associated with early relapse and poor treatment outcomes in addictions and mood-disorders. Lithium carbonate can be helpful in moderating the impulsive behaviors associated with mania, possibly mediated by reduced myo-inositol activity following inhibition of the enzyme inositol monophosphatase (IMPase). We tested the hypothesis that impulsivity-as motor disinhibition, decisions without adequate information, and stronger preferences for small immediate rewards over larger later rewards-can be moderated by the IMPase inhibitor ebselen in healthy adult volunteers. One hundred and thirty healthy adults completed a between-subjects, double-blind, placebo-controlled protocol. Over 2 days, participants received a previously validated dose of 1800 mg of ebselen or placebo before completing tests of impulsivity and decision-making. There were no substantive changes in any measure of impulsivity following treatment with ebselen compared with placebo. Neither was there any convincing evidence of stronger treatment effects in high-trait impulsive participants compared with low-trait participants. These results fail to replicate findings that ebselen administration moderates validated measures of impulsivity in healthy adults, at least at doses shown to reduce myo-inositol within the medial prefrontal cortex and produce changes in emotional processing and reward-based learning.
Rehabilitacion · 2026
Knee osteoarthritis is one of the leading causes of disability worldwide and represents a major public health concern. Currently, metabolic and inflammatory factors are recognized as pathogenic elements to the extent that osteoarthritis has been redefined as a condition characterized by "low-grade chronic inflammation." In this context, interest has grown in regenerative medicine therapies such as platelet-rich plasma (PRP) and hyaluronic acid (HA), used either individually or in combination. The aim of this study was to synthesize recent evidence on the efficacy and safety of these interventions in the treatment of knee osteoarthritis. A systematic review of the literature published between 2018 and 2024 was conducted in PubMed, Scopus, and ScienceDirect, using terms related to osteoarthritis, PRP, and HA. Six studies meeting the eligibility criteria were selected. The results showed that PRP provided superior benefits in pain reduction and functional improvement compared with HA, particularly in long-term follow-up. Combined therapy with PRP + HA demonstrated additional advantages in some studies, both in clinical efficacy and safety. Regarding safety, the combination was associated with a lower frequency of adverse events such as hypertension and proteinuria. In conclusion, PRP emerges as a more effective therapeutic option than HA for knee osteoarthritis, while the combination of PRP + HA may offer complementary benefits. However, methodological heterogeneity limits comparisons across studies, underscoring the need for research with larger sample sizes and standardized protocols for PRP preparation and administration.
Journal of cosmetic dermatology · 2026
Skin aging, marked by wrinkles, volume loss, and reduced hydration, has driven growing interest in minimally invasive aesthetic treatments to restore skin quality and appearance. This study aimed to evaluate the efficacy and safety of an injectable formulation combining hyaluronic acid (HA) and amino acids (AA) for facial rejuvenation in adults. A systematic review and meta-analysis was conducted according to the PRISMA guidelines using PubMed, EMBASE, Scopus, and the Cochrane Library. Eligible studies compared HA + AA complexes with conventional HA or a placebo. The primary efficacy outcomes were changes in wrinkle severity (WSRS), aesthetic improvement (GAIS), skin thickness, and epidermal growth factor (EGF)-positive cell viability. Safety was assessed by adverse event reporting. This meta-analysis included 11 studies that met the inclusion criteria. A significant reduction in wrinkle severity was observed on WSRS following treatment (MD, 2.15; 95% CI, 2.00-2.30; p < 0.0001). Global aesthetic improvement demonstrated a marked enhancement at 3 months (MD = 3.13; 95% CI = 1.94-4.33; p < 0.00001). Dermal thickness significantly increased post-treatment (MD = -0.42 mm; 95% CI = -0.55 to -0.30; p < 0.00001). Cell viability improved significantly (MD = -24.00; 95% CI = -25.16 to -22.84; p < 0.00001). There was a statistically significant difference in adverse events (RR = 5.20; 95% CI = 0.53-50.77; p = 0.16). Amino acid-enriched hyaluronic acid improves wrinkle severity, dermal thickness, and cell viability, enhancing overall skin aesthetics. Larger prospective studies are needed to confirm these findings.
Autoimmunity reviews · 2026
Patients with systemic sclerosis (SSc) or morphea increasingly inquire about cosmetic procedures, as these conditions often result in disfiguring cutaneous manifestations such as microstomia, thin lips, sclerotic plaques or skin atrophy. Traditionally, rheumatologists prioritize immunosuppression and disease control but often fail to address aesthetic concerns. Among available interventions, hyaluronic acid (HA) fillers offer a minimally invasive approach, yet there is not enough information regarding efficacy and safety in this population. This systematic review aims to discuss current evidence regarding the use of HA fillers in patients with SSc or morphea. A literature search was conducted in PubMed, CENTRAL and clinicaltrials.gov from inception until January 2025. Two independent reviewers examined the studies and extracted data. Data regarding the number of patients, disease type, HA filler particulars, technique, additional treatments, immunosuppression, patient reported or other outcomes and follow-up were extracted. Nineteen studies met the inclusion criteria, consisting of 8 case reports, 7 case series and 4 prospective interventional studies (including one controlled study). Most common areas were the forehead, chin and perioral region. Some studies used adjuvant treatments such as Botox or Platelet-Rich Plasma (PRP). HA fillers were consistently associated with patient satisfaction and good cosmetic results. In patients with SSc, mouth opening improved and microstomia was alleviated. However, one controlled study reported no significant improvement in mouth opening compared to autologous fat grafting. Inactive morphea lesions appeared to be more responsive compared to inflammatory ones. Adverse events were mild with no reports of disease flare. HA fillers appear to be a safe and minimally invasive procedure for addressing both functional and aesthetic concerns of patients with SSc or morphea. Further randomized controlled trials are needed to clarify indications, durability and long-term safety.
BMJ open ophthalmology · 2026
ObjectiveTo study the properties of different ophthalmic viscosurgical devices (OVDs) with respect to their ability to create and maintain high intraocular pressure (IOP) during the creation of a continuous curvilinear capsulorhexis (CCC) by comparing the drop in IOP before and after creation of the CCC. The study included 174 eyes in four groups using two different OVDs (hyaluronic acid (HA) and hydroxypropylmethylcellulose (HPMC)) and two different instruments (utrata forceps (UF) and 26G cystotome (RN)). IOP was measured using rebound tonometry with sterilised probes immediately before the beginning of the CCC and immediately afterwards during cataract surgery. The drop in IOP during capsulorhexis was measured at 52.1±10.7 mm Hg with the combination HA/RN, 62.4±11.5 mm Hg with HA/UF, 60.5±10.0 mm Hg with HPMC/RN and 68.7±14.1 mm Hg with HPMC/UF. The variance in IOP reduction between HA and HPMC did not reach statistical significance (p=0.100). The lack of a noticeable difference in IOP levels, despite the use of different OVDs with unique properties, indicates that IOP may not be the main factor influencing the notable differences in tactile feedback perceived by surgeons during capsulorhexis procedures conducted with varying OVDs. To elucidate these sensations, additional characteristics such as viscosity, elasticity, pseudoplasticity and cohesion will have to be explored.
Clinical oral investigations · 2026
To provide an overview on the effect of hyaluronic acid (HyA) on hard tissue healing in alveolar bone augmentation procedures in humans (PROSPERO registration: CRD42023464863). Three databases were searched until April 2025. Studies using HyA in any form and in any alveolar bone augmentation procedure were included, if a control group allowing to assess the effect of HyA was available; studies addressing periodontal regeneration or using HyA coated implants were not included. Primary outcome parameters, summarized descriptively, were histologic/radiographic new bone formation (NBF), alveolar ridge width (ARW) and height (ARH). The Cochrane Collaborations RoB 2.0 and ROBINS-I tool were used to assess the risk of bias. Fourteen studies with a follow-up of 3-12 months were included, which contributed with 229 patients and 317 sites allowing to assess the effect of HyA. HyA was assessed as adjunct to maxillary sinus floor augmentation (MSFA), guided bone regeneration (GBR), and alveolar ridge preservation (ARP). The addition of HyA significantly improved NBF in 50 and 66% of the MSFA and ARP studies, respectively; however, a significant clinical improvement was not consistently observed. Advantages for NBF as well as ARW or ARH gain have been reported in GBR procedures, but the available data are limited and mostly descriptive. No differences were observed regarding reported post-operative complication rates. Due to the heterogeneity in treatments and outcome measures, as well as the limited number of studies, a meta-analysis was not feasible for any of the outcomes. In the original studies, positive and occasionally significant results have been reported for the adjunct use of HyA in alveolar bone augmentation; however, the effect size and clinical relevance is unclear, and further clinical research is needed. HyA in alveolar bone augmentation is safe, but it remains unclear in which indication and in which application form it may enhance quality and/or quantity of NBF and at what extent.
Journal of back and musculoskeletal rehabilitation · 2026
BackgroundIn recent years, research on mesenchymal stem cells (MSCs) for treating Discogenic Low Back Pain (DLBP) has been steadily increasing, yet there remains a lack of Meta-analysis focusing specifically on autologous MSCs (AMSCs) for this condition. This study comprehensively analyzes all published research on AMSCs in the treatment of DLBP and summarizes the evidence-based medical findings regarding the efficacy of this regenerative therapy for DLBP.MethodsA comprehensive literature search was conducted across PubMed, Embase, Web of Science, and Ovid databases for articles published from database inception through April 2025. Following rigorous screening of all identified studies investigating AMSCs for DLBP treatment and performing a meta-analysis to evaluate the collective evidence.ResultsFour studies were included in our analysis, all of which were prospective single-arm trials (PSATs). The meta-analysis demonstrated significant reductions in Visual Analog Scale (VAS) and Oswestry Disability Index (ODI). Pain score decreased by >30% and >50% from baseline, with incidence rates of 52.20%, 66.00%, 67.90%, and 76.80% for >30% reduction, and 34.21%, 50.74%, 69.32%, and 67.74% for >50% reduction at these respective time points. Subgroup analysis revealed no statistically significant difference in the incidence of >30% or >50% pain score reduction between the AMSCs + hyaluronic acid (HA) combination group and AMSCs monotherapy group at equivalent follow-up intervals.ConclusionIntradiscal injection of AMSCs demonstrates both safety and clinical efficacy in the treatment of DLBP. The 6-month follow-up represents a clinically meaningful timepoint for evaluating the therapeutic effects of AMSCs. No significant differences were observed between AMSCs combined with HA and AMSCs monotherapy in terms of clinical outcomes.
Reproductive biomedicine online · 2026
Does combined treatment with hyaluronic acid and prolactin (PRL) for post-warming culture and embryo transfer increase the live birth rate after single vitrified-warmed blastocyst transfer (SVBT)? A three-arm, double-blind, randomized controlled trial (RCT) was conducted between October 2020 and May 2021. Overall, 1236 couples undergoing SVBT were randomized using a 1:1:1 ratio into three groups: after removing the zona pellucida, warmed blastocysts were incubated in a medium without hyaluronic acid or PRL (control group), a hyaluronic-acid-enriched transfer medium (EmbryoGlue group), or EmbryoGlue supplemented with PRL (EGP group) for 2-4 h prior to transfer in the same medium. The primary outcome was the live birth rate. The live birth rate was higher in the EGP group compared with the control (OR 1.40; P = 0.0219) and EmbryoGlue (OR 1.38; P = 0.0266) groups. Although positive pregnancy and clinical pregnancy rates were comparable among the three groups, the ongoing pregnancy rate was higher in the EGP group compared with the control (P = 0.0142) and EmbryoGlue (P = 0.0249) groups. Furthermore, the rate of early pregnancy loss was lower in the EGP group compared with the control (P = 0.0073) and EmbryoGlue (P = 0.0053) groups. Subgroup analysis demonstrated significant interactions for embryo culture time (P = 0.0494) and serum progesterone (P = 0.0045): EGP treatment was effective for day 4-5 blastocysts and patients with insufficient serum progesterone. This RCT suggests that combined treatment with hyaluronic acid and PRL is effective for improving the live birth rate in good-prognosis patients by reducing early pregnancy loss.
Journal of medicinal food · 2026
Skin aging, driven by intrinsic and extrinsic factors, leads to wrinkles and dryness, primarily due to reduced levels of collagen and hyaluronic acid. Agastache rugosa extract (Agatri®, AG) and a complex of A. rugosa, Ficus carica, and Lycium barbarum extracts (AGEs Blocker™, AB) have been suggested to support skin health in previous studies. Based on preclinical evidence supporting AB's superior efficacy compared to AG, we aimed to investigate whether these effects could also be observed in humans. To this end, we directly compared the effects of AG and AB on skin parameters in a randomized, double-blind, placebo-controlled trial. Forty-five participants were randomized to receive AG (1000 mg/day), AB (500 mg/day), or maltodextrin tablets for 12 weeks. After 8 and 12 weeks of supplementation, both AG and AB significantly reduced wrinkle size and transepidermal water loss compared to placebo. The skin moisture content, dermal density, and elasticity were also improved by supplementation with AG and AB. Notably, AB demonstrated greater efficacy than AG in enhancing these skin parameters. Taken together, this study provides the first clinical evidence that both AG and AB supplementation improves multiple features of skin aging, with AB demonstrating superior efficacy. These findings suggest that AG and AB may serve as promising candidates for the development of dietary supplements targeting skin health.
International journal of molecular sciences · 2026
Injectable skin boosters currently in use mainly provide short-lived volumization or depend on inflammation-mediated collagen stimulation, raising concerns regarding durability and safety. Injectable particulate human acellular dermal matrix (phADM) is a biologically derived extracellular matrix scaffold designed to support constructive dermis remodeling. This randomized, split-face, double-blinded clinical trial evaluated the efficacy of phADM as a facial skin booster in 20 adults with moderate cheek roughness. phADM was injected on one facial side, with hyaluronic acid serving as the contralateral control. Multiple skin parameters were assessed over 20 weeks using validated imaging and biophysical instruments. Mechanistic validation was conducted using complementary in vitro, ex vivo human skin, and in vivo rat models. Clinically, the phADM-treated side demonstrated greater improvements in skin density, volume, elasticity, wrinkle depth, pore area, hydration, and barrier-related parameters at multiple time points compared with HA. In ex vivo human skin, phADM showed homogeneous dermal distribution and preservation of extracellular matrix architecture, along with restoration of basement membrane-associated proteins following UVB irradiation. In vivo rat studies revealed fibroblast infiltration and localized neocollagenesis within the implanted matrix. In vitro assays further indicated enhanced fibroblast proliferation and extracellular matrix synthesis, increased hyaluronan production, suppression of pro-inflammatory cytokines in activated macrophages, and downregulation of melanogenesis-related genes in melanoma cells. No serious adverse events were observed during the clinical study. These findings indicate that phADM functions as a restorative skin booster that promotes durable dermis remodeling and functional rejuvenation with a favorable safety profile.
BMC oral health · 2026
This systematic review analyzes postoperative complications at the palatal donor site following the harvesting of autologous soft tissue grafts in periodontal surgery. Although these grafts remain the clinical reference standard due to their effectiveness, their harvesting may be associated with donor-site morbidity, including pain, bleeding, partial necrosis, and sensory disturbances. A comprehensive search was conducted in PubMed, Scopus, and Web of Science, identifying 16 clinical studies published between 2019 and April 2025. The included studies comprised randomized controlled trials, prospective and retrospective clinical studies, and case series, with sample sizes ranging from 6 to 89 participants. Due to heterogeneity in study designs, outcome measures, and follow-up protocols, a qualitative synthesis was performed and a quantitative meta-analysis was not feasible. Postoperative pain was the most frequently reported complication and was commonly assessed using the Visual Analog Scale (VAS), although other instruments such as the Numeric Rating Scale (NRS) were also used. Several adjunctive strategies, including palatal stents, hyaluronic acid, platelet-rich fibrin (PRF), mucoadhesive dressings, and low-level laser therapy (LLLT), were reported to be associated with lower postoperative discomfort and favorable healing patterns. Bleeding was reported less frequently and was generally self-limiting, particularly when local hemostatic measures were applied. Sensory disturbances were typically mild and transient, resolving during routine follow-up. No serious infections or complications compromising patient health were reported. In conclusion, while morbidity at the palatal donor site is relatively common, it is generally mild and manageable. Certain adjunctive measures may help reduce postoperative discomfort and support healing; however, the overall strength of the available evidence remains moderate. These findings may help improve postoperative recovery and inform future clinical research. The online version contains supplementary material available at 10.1186/s12903-026-07989-1.
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association · 2026
To evaluate pain relief, functional recovery, and tear size progression following different conservative treatments for partial-thickness rotator cuff tears. This study adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Data sources including PubMed, the Cochrane Library, Embase, Scopus, and Web of Science were searched from January 1, 2005, to December 30, 2024. The search strategy employs the terms (rotator cuff AND (tear OR injury)) AND (partial OR incomplete). Only randomized controlled trials investigating conservative treatments specifically for partial-thickness rotator cuff tears are included. The revised Cochrane risk-of-bias tool for randomized controlled trials (RoB 2) was utilized to assess the methodological quality. Sixteen studies were included in the network meta-analysis. The network meta-analysis results comprised mean improvements in Visual Analog Scale, American Shoulder and Elbow Surgeons score, and Constant-Murley score at various follow-up time points. Platelet-rich plasma (PRP) was the most frequently reported conservative treatment, followed by steroids, sodium hyaluronate, and normal saline. When compared with normal saline, other conservative treatments showed no statistically significant differences in mean improvements across the three scoring systems at different follow-up periods. Subgroup analysis restricted to Level I randomized controlled trials or subacromial injection studies yielded similar network meta-analysis results. Both rank probability plots and cumulative probability rankings consistently identified the combination of PRP and sodium hyaluronate as the highest-ranked treatment. The results regarding tear size could not be pooled for analysis due to substantial heterogeneity across studies, although PRP appeared to show a potential for promoting tear healing. PRP represents the most frequently reported conservative treatment for partial-thickness rotator cuff tears. Compared with normal saline, none of the conservative therapies show statistically significant improvements in pain relief or functional recovery across all follow-up periods. Level II, systematic review and network meta-analysis of Level I and II randomized controlled trials.
Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2026
To investigate the clinical efficacy of thumbtack needling combined with sodium hyaluronate eye drops in the treatment of moderate-to-severe dry eye. A total of 72 patients with moderate-to-severe dry eye were randomly divided into a thumbtack needling group and a conventional treatment group, with 36 patients in each group. The conventional treatment group received sodium hyaluronate eye drops, while the thumbtack needling group received additional thumbtack needling based on the same conventional therapy. The selected points for thumbtack needling included bilateral Jingming (BL1), Chengqi (ST1), and Qiuhou (EX-HN7). Treatment was performed twice a week for four consecutive weeks. Traditional Chinese medicine (TCM) syndrome scores, first non-invasive tear break-up time (NIBUTf), average non-invasive tear break-up time (NIBUTav), Schirmer Ⅰ test (SⅠT), corneal fluorescein sodium staining (FL) score, ocular surface disease index (OSDI) score before and after treatment, and adverse event incidence were compared between the two groups. Clinical efficacy was also evaluated. Compared before treatment, the TCM syndrome scores (individual and total), FL scores, and OSDI scores were significantly lower in both groups after treatment (P<0.05), with the thumbtack needling group showing greater reductions than the conventional treatment group (P<0.05). Compared before treatment, NIBUTf, NIBUTav, and SⅠT were significantly increased in both groups after treatment (P<0.05), with the thumbtack needling group showing greater improvements than the conventional treatment group (P<0.05). The incidence of adverse reactions was 5.6% (2/36) in the thumbtack needling group, which was lower than 11.1% (4/36) in the conventional treatment group (P<0.05). The total effective rate was 97.2% (35/36) in the thumbtack needling group, which was significantly higher than 83.3% (30/36) in the conventional treatment group (P<0.05). Thumbtack needling combined with sodium hyaluronate eye drops could effectively improve tear film stability, tear secretion volume, and corneal epithelial damage in patients with moderate-to-severe dry eye. This combined therapy demonstrates favorable clinical efficacy and a lower incidence of adverse reactions. 目的：探讨揿针联合玻璃酸钠滴眼液治疗中重度干眼中的临床疗效。 方法：将72例中重度干眼患者随机分为揿针治疗组和常规治疗组，每组36例。常规治疗组接受玻璃酸钠滴眼液治疗，揿针治疗组在常规治疗组的基础上予揿针治疗，取双侧睛明、承泣、球后。每周治疗2次，连续治疗4周。比较两组患者治疗前后中医证候评分、首次泪膜破裂时间（NIBUTf）、平均泪膜破裂时间（NIBUTav）、泪液分泌试验Ⅰ（SⅠT）、角膜荧光素钠染色（FL）评分、眼表疾病指数（OSDI）评分和不良反应发生率，并评定临床疗效。 结果：治疗后，两组患者各项中医证候评分及总分、FL评分、OSDI评分均较治疗前降低（P<0.05），且揿针治疗组低于常规治疗组 （P<0.05）；两组患者NIBUTf、NIBUTav、SⅠT均较治疗前升高（P<0.05），且揿针治疗组高于常规治疗组（P<0.05）。揿针治疗组不良反应发生率为5.6%（2/36），低于常规治疗组的11.1%（4/36，P<0.05）。揿针治疗组的总有效率为97.2%（35/36），高于常规治疗组的83.3%（30/36，P<0.05）。 结论：揿针联合玻璃酸钠滴眼液可改善中重度干眼患者的泪膜稳定性、泪液分泌量及角膜上皮损伤程度，具有较好的临床疗效和较低的不良反应发生率。.
Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026
The endothelial glycocalyx (EG) is a key regulator of vascular homeostasis, acting as a dynamic barrier between the bloodstream and the endothelium. In pregnancy, structural and functional alterations of the EG have been increasingly implicated in the pathogenesis of endothelial dysfunction, particularly in preeclampsia and other vascular complications. This systematic review critically examines current evidence on circulating biomarkers of EG degradation and their clinical relevance in hypertensive and metabolic disorders of pregnancy. We explore the mechanistic role of the glycocalyx in maintaining vascular integrity, evaluate state-of-the-art detection methods-including sidestream dark field (SDF) imaging and biochemical assays-and summarize data on key circulating components such as syndecan-1, hyaluronic acid, heparan sulfate, and adhesion molecules. Particular attention is given to distinguishing early- from late-onset preeclampsia and to other high-risk obstetric conditions, including gestational diabetes, fetal growth restriction, and infection-related complications. Despite heterogeneity across studies, most findings support a consistent association between EG disruption and adverse maternal-fetal outcomes. This review highlights the potential of glycocalyx-derived biomarkers and imaging tools as non-invasive indicators of microvascular injury. Their integration into existing surveillance models could enhance early risk stratification and open new avenues for targeted clinical interventions in cardio-obstetric care.
The Medical journal of Malaysia · 2026
Despite advances in the development of mesenchymal stem cells (MSCs), the ultimate benefits of MSCs against current cell-based therapies are still limited. This study aimed to assess the safety, feasibility, and efficacy of Cytopeutics® umbilical cord-derived MSCs (Chondrocell-EX) in patients with knee cartilage injury. The study was conducted in two parts: a phase I feasibility study (PI) followed by a phase II randomized controlled trial (PII). Both studies were approved by UKM Research Ethics Committee (PI: UKM PPI/111/8; PII: UKM PPI/111/8/JEP-2019-304). Six patients were involved in the PI study in which all patients received Chondrocell-EX and 28 patients in the following PII study, where 17 patients received Chondrocell-EX with Hyaluronic acid (HA) (Arm A) and 11 patients received commercially available cell-based therapy, which is Bone Marrow Aspirate Concentrate (BMAC) with Hyaluronic acid-based scaffold (HA-S) (Arm B). Safety was assessed based on the occurrence of adverse events, while clinical outcomes were assessed based on the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Pain Visual Analog Scale (VAS). Second-look arthroscopy and histological assessment were performed to assess their structural outcomes at 12 months. In the PI feasibility study, significant pain reduction began at 3 months, with mean VAS decreasing from 6.83 ± 0.98 at baseline to 4.83 ± 1.17 (p < 0.01), 3.00 ± 0.00 at 6 months (p < 0.01), and 1.83 ± 0.75 at 12 months (p < 0.01). In the PII study, Arm A (Chondrocell-EX + HA) demonstrated significant VAS improvements at all follow-up points compared to baseline (p < 0.001), whereas Arm B (BMAC + HA-S) showed significant reductions only from 3 months onward. After adjustment for baseline age and VAS, Arm A achieved significantly lower pain scores than Arm B at 6 months (2.56 ± 1.41 vs 3.09 ± 1.22; p = 0.015) and 12 months (2.27 ± 1.49 vs 2.50 ± 1.35; p = 0.043), indicating earlier and sustained pain relief with Chondrocell-EX injection. Functional outcomes mirrored pain improvements. In PI, KOOS scores improved significantly from 3 months, reaching 85.83 ± 11.87 at 12 months (p < 0.01). In PII, KOOS increased significantly in both arms (p < 0.001), but Arm A demonstrated earlier gains at 3 months and significantly higher adjusted KOOS scores than Arm B at 6 (p = 0.009) and 12 months (p = 0.037). In KOOS subdomains analysis, it showed significantly greater improvements in Arm A, particularly in symptoms and stiffness, activity of daily living (ADL), pain, sport and recreation, and quality of life (QoL) at key time points. Chondrocell-EX+HA treatment is more convenient, feasible, and minimally invasive with the findings suggesting that it is associated with faster functional improvement and pain relief, along with demonstration of hyaline-like cartilage regeneration, compared to the BMAC+HA-S method.
Plastic and aesthetic nursing · 2026
Skin aging causes cumulative structural, physiological, and progressive skin changes, as well as wrinkles, uneven skin tone, elasticity loss, and skin thinning. We performed a systematic review of nine studies involving 278 participants to assess the efficacy and safety of the stable, hybrid cooperative complexes of high molecular weight hyaluronic acid (HCC-HA) and low molecular weight hyaluronic acid used in Profhilo® and Profhilo® Body (IBSA Farmaceutici Italia Srl, Lodi, Italy) on skin laxity, elasticity, hydration, density, wrinkle severity, and facial volume loss. We found that treatment with Profhilo® and Profhilo® Body led to a statistically significant change or a trend toward an improvement in mean viscoelasticity, elasticity, or plastoelasticity parameters (malar/submalar regions of the face, neck, inner arms, abdomen, and hands); skin hydration (malar/submalar face regions, the neck, inner arms, abdomen, and knees); skin density parameters (face, neck, inner arms, abdomen, hands, and knees); skin laxity (neck, inner arms, abdomen, knees, and hands); and Wrinkle Severity Rating Scale and Facial Volume Loss Scale scores (face). Photographic evidence showed improved skin turgor, tone, and texture, reduced nasolabial fold depth and wrinkles, and overall amelioration. Adverse events (i.e., bruising, edema, a light pinching sensation, a small bump, localized hematomas) were mild, expected, and usually resolved within 72 hours. Profhilo® and Profhilo® Body can improve skin laxity, hydration, elasticity, and density while reducing wrinkles and facial volume loss.
Acta orthopaedica Belgica · 2025
Chondromalacia patellae (CMP) is a cartilaginous degeneration of patellofemoral joint caused by a variety of reasons. Recent studies have shown that the incidence of patellomalacia is getting higher and higher. Our meta-analysis is used to illustrate the clinical effect of external treatment of traditional Chinese medicine combined with joint cavity injection of sodium hyaluronate in the treatment of patellomalacia. Literature searches were carried out in various databases, such as PubMed, Cochrane Library, China Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang, and Weipu, with the search timeline extending from the inception of each database until April 2024. Two investigators independently conducted literature screening, data extraction, and quality assessment of the included studies. Review Manager 5.4 software was used to perform a meta-analysis, which evaluated changes in the clinical efficacy rate, visual analogue scale (VAS) scores, and time of symptom onset before and after treatment. The study included a total of 11 randomized controlled trials (RCTs) involving 1,279 patients. The meta- analysis results indicated that compared to the standalone injection of sodium hyaluronate, the combination of TCM topical therapy significantly enhanced the clinical efficacy rate in treating CMP [RR=1.17, 95% CI=[1.12,1.22], P<0.00001]. Furthermore, the addition of TCM topical therapy lowered the VAS score in patients with CMP five weeks post-treatment compared to the control group. In comparison to the standalone injection of sodium hyaluronate, the combination of TCM topical therapy showed a quicker onset, thus reducing patients' pain [RR=-7.44, 95% CI=(-9.86,-5.01), P<0.00001]. The combination of TCM topical therapy and sodium hyaluronate intra-articular injection demonstrated superior clinical efficacy over the sole intra-articular injection of sodium hyaluronate. This combination effectively mitigated pain in patients and had a faster onset.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2026
Hyaluronidases (HAase) increase tissue permeability by depolymerizing hyaluronan in the extracellular matrix. Consequently, the subcutaneous (SC) delivery of substantial volumes of fluids or biotherapeutics is facilitated. Recombinant human hyaluronidase PH20 (rHuPH20) has been developed to overcome the allergic and immunologic risks associated with animal-derived HAase. However, standalone rHuPH20 products remain unavailable in China despite increasing clinical demand. Two randomized, double-blind, self-controlled phase III clinical trials (phase IIIa and IIIb) were conducted to evaluate the SC infusion rate, tolerability and safety of KJ017, a rHuPH20, in healthy participants receiving gravity-driven SC infusion. The primary outcome was SC infusion rate. The secondary outcomes included arm circumference, time to recover baseline arm circumference, and safety evaluations, such as adverse events (AEs). Across both trials, SC infusion rates in all KJ017 groups (128/150 IU, 385 IU, and 1540/1500 IU) were significantly higher than those in the placebo groups (all P < 0.001). KJ017 administration was associated with minimal increases in limb circumference at the infusion site, suggesting reduced local fluid accumulation and more efficient tissue dispersion of the infused solution. SC administration of KJ017 across a dose range of 128  IU to 1540  IU was well tolerated and safe, and no allergic reactions were documented. These phase III trials demonstrate that KJ017 effectively enhances gravity-driven SC infusion performance while maintaining favorable safety and tolerability. By increasing SC tissue permeability, KJ017 enables the delivery of clinically relevant fluid volumes through the SC route across multiple anatomical sites. These findings support the further development of KJ017 as an enabling agent for large-volume SC administration and for potential co-administration with therapeutic agents requiring rapid or high-volume SC delivery. Trial registrationChictr.org.cn, ChiCTR2100049727 and ClinicalTrials.gov, NCT06604546.
Critical care explorations · 2026
Test the hypothesis that conservative fluid management with active deresuscitation would not adversely affect tissue perfusion or kidney injury and would be associated with reduced vascular injury compared with usual care. Secondary analysis of the Role of Active Deresuscitation After Resuscitation-2 (RADAR-2) trial. ICUs. Critically ill patients enrolled in the RADAR-2 trial. Conservative fluid management with active deresuscitation vs. usual care. Measures of tissue hypoperfusion (whole blood lactate), acute kidney injury (AKIRisk score and urinary cystatin-C), and vascular injury (plasma hyaluronan, syndecan-1, and angiopoietin-2) were compared between groups. For each analyte, change from baseline was compared between groups and the median inter-group difference at each timepoint was estimated with bootstrapped CIs. Exploratory logistic regression examined associations between plasma biomarker levels (including N-terminal pro-B-type natriuretic peptide [NT-proBNP]), 28-day mortality, and treatment allocation. Whole blood lactate levels were similar between groups at all timepoints. Using change from baseline comparisons, no statistically detectable between-group differences were observed in AKIRisk scores or urinary cystatin-C levels. Plasma vascular injury biomarkers showed no statistically detectable between-group differences at any timepoint. High baseline hyaluronan (adjusted odds ratio [aOR], 5.75; 95% CI, 1.94-17.02; p = 0.002), syndecan-1 (aOR, 8.82; 95% CI, 2.67-29.15; p < 0.001), and NT-proBNP greater than 2500 pg/mL (aOR, 21.48; 95% CI, 3.57-129.41; p < 0.001) were independently associated with increased 28-day mortality. There was no evidence of differential treatment response based on these biomarker levels. Conservative fluid management and active deresuscitation were not associated with worsening tissue perfusion or acute kidney injury. A reduction in vascular injury markers was not observed. Given the modest sample size and resultant imprecision, clinically important effects cannot be excluded.