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Background Radiation-induced skin injury (RSI) is a common complication of radiation therapy, that severely reduces the quality of life of patients, and there is currently no gold standard for treatment. Placental mesenchymal stem cells (PMSCs) have emerged as a promising therapeutic approach due to their regenerative and anti-inflammatory properties, and biomaterials can serve as cell scaffolds to prolong cell survival time. This study is the first to evaluate the safety and efficacy of the a topical application of PMSCs-embedded alginate hydrogel (PMSCs gel) in cancer patients suffering from RSI. Materials and methods This study was a double-blind, randomized, placebo-controlled phase II clinical trial conducted at Yunnan Cancer Hospital (Chinese Clinical Trial Registry, Approval Number: ChiCTR2400094739) involving participants with grade II or higher radiation-induced skin injuries. The participants were randomly assigned to either the PMSCs gel treatment group or the placebo control group and treated topically for six consecutive days. The primary outcomes included skin injury grade, pain assessment and wound healing rate, whereas the secondary outcomes focused on biomarker changes and quality of life assessments. Statistical analyses were performed using intention-to-treat (ITT) principles. Results This study included 66 patients, 23 males, and 43 females, with a mean radiation-induced skin injury area of 779 mm 2 . Compared with the placebo control group, the PMSCs gel treatment group presented a faster overall recovery rate compared to the placebo control group, with statistically significant daily improvements from Day 1 to Day 6. Although there was no significant difference in the full healing rates between the groups, the PMSCs gel treatment significantly prevented further wound expansion from Day 2 to Day 6. Moreover, overall pain relief was greater in the PMSCs gel treatment group than in the control group. Conclusions Our study has demonstrated for the first time that PMSCs hydrogel have significant potential for accelerating the repair of radiation-induced skin damage and reducing skin pain. Trial registration This retrospectively registered Chinese Clinical Trial Registry identifier: ChiCTR2400094739 ( https://www.chictr.org.cn/bin/project/edit?pid=250420 ).

Background Soft tissue fillers are used to improve the appearance of nasolabial folds (NLFs). This study aimed to compare the efficacy and safety of a new calcium hydroxylapatite microsphere hydrogel filler (Aphranel) versus Restylane for correcting NLFs. Methods In this multicenter, randomized, double-blind, parallel-grouped, positive-controlled, non-inferiority trial, 210 subjects were randomized to bilateral NLF treatment with Aphranel and Restylane on either side of the NLF. NLF was assessed before and right after injection and at the first week, first month, third, sixth, and 12 months. The primary efficacy endpoint was the WSRS improvement rate for the NLF, defined as ≥ 1 point improvement at Week 24. The secondary efficacy endpoints include the WSRS score assessed by investigators and the independent review committee (IRC) and the Global Aesthetic Improvement Scale (GAIS) evaluated by the subjects, investigators, and IRC over time. Randomization was performed using a computer-generated randomization list. To ensure the double-blind nature of the study, neither the physicians administering the injections nor the patients receiving them were aware of the specific product being used. All syringes were identical in appearance, with labels coded instead of indicating the product name. The preparation of the injection products was handled by nurses who were not involved in the treatment process, thereby maintaining the blinding of both the physicians and the patients to the treatment assignment. Results A total of 188 subjects (168 women and 20 men) completed the 12-month follow-up. The investigator-evaluated improvement rates using WSRS at 24 weeks were 84.04% for Aphranel and 78.72% for Restylane. The IRC-evaluated improvement rates using WSRS at 24 weeks were 72.34% for Aphranel and 70.21% for Restylane. Aphranel was shown to be statistically non-inferior to Restylane ( P >0.05). Both the investigator and IRC-assessed WSRS scores over time showed that the mean scores for Aphranel were non-inferior to the mean scores for Restylane (all P >0.05). There was no difference between the Aphranel and Restylane groups according to the subjects, investigators, and IRC-assessed GAIS score at any time point (all P >0.05). Both devices' most frequently reported adverse events were injection site swelling and procedural pain. Conclusion This study confirms that Aphranel is an effective and safe treatment for correcting NLFs in Chinese subjects. Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

One of the most frequently impacted locations by psoriasis is the scalp. It is seen in about 80% of psoriasis cases worldwide, and its treatment is challenging. To compare the efficacy and safety of excimer light versus topical methotrexate (MTX) 1% hydrogel in treatment of scalp psoriasis. This randomized prospective intra-patient comparative study was carried out on 30 patients with scalp psoriasis. Lesions were divided randomly into two areas: Area A and Area B. Area A received biweekly sessions of 308-nm excimer light and Area B received topical MTX 1% hydrogel once daily for 3 consecutive months. Psoriatic Scalp Severity Index (PSSI), itching score, patient satisfaction and dermoscopic red dots and white scales were used for assessment at the baseline, at the end of treatment protocol and 1 month after the last treatment session. Both treatment modalities induced significant improvement in PSSI, itching score and dermoscopic red dots and white scales (p < 0.001 for each). The mean percentage of improvement of PSSI was 75.82 ± 33.72 in Area A and 74.19 ± 31.64 in Area B with non-significant difference between both areas (p = 0.763). Moreover, the mean percentage reduction of itching score was 77.40 ± 24.61 in Area A and 67.67 ± 34.94 in Area B with non-significant difference between both areas (p = 0.430). Additionally, a notable improvement in dermoscopic red dots and white scales was observed in 83.3% of patients in Area A and in 60% in Area B at the end of treatment protocol with non-significant difference between both areas (p = 0.518) (p = 0.436). Marked patient satisfaction was noticed in both areas with non-significant difference between both areas (p = 0.433). 308-nm excimer light and topical MTX 1% hydrogel are equally safe and effective treatment options for scalp psoriasis with minimal side effects.

Objective Salicylic acid (SA) has been used for treatment of acne of different severity levels. However, there are few researches about the safety and efficacy for treatment of mild to moderate acne, and the improvement of the skin condition by using 2% supramolecular salicylic acid (SSA) compared to Davuwen Adapaline gel. Methods A multicenter, randomized, assessor‐blind and parallel‐controlled study was conducted. A total of 500 patients (trial group: 249, control group: 251) with mild to moderate (grade I–II) facial acne vulgaris were recruited in this study over a 16‐week trial period. Patients in the trial group were treated with Broda 2% SSA hydrogel, while control group treated with Davuwen Adapaline gel once a day. The number of inflammatory papules, comedones, and pustules were counted and the rate of lesion reduction was calculated pre‐ and post‐treatment. Then, the skin physiological indicators, including L*a*b*, TEWL, skin sebum and hydration were measured. Statistical analysis was conducted using SAS 9.4. Significance was set at p = 0.05. Results At the end of 12 weeks' therapy, the regression and markedly improvement rate of the trail group and the control group were 51.01% and 43.10% respectively, and there was no significant difference in the improvement rate between two groups (p = 0.0831). Although, there was no difference in adverse events rate between two groups, the adverse events rate of the trail group was 0.40%, a little lower than the control group (0.80%). Moreover, there was a significant difference in the numbers of pores at T1 between two groups. Conclusion Both 2% SSA and Adapaline gel were equally effective in the treatment of mild to moderate acne vulgaris. 2% SSA is worth the clinical promotion and application in mild to moderate acne vulgaris.

Background Studies have evaluated the concomitant use of hyaluronan (HA) with steroids, anti-inflammatory drugs and analgesic agents in an attempt to magnify the extent and duration of pain relief due to knee osteoarthritis. To date there has not been an intra-articular combination therapy available for relief of knee osteoarthritis symptoms – one that combines the fast acting onset of symptom relief provided by a corticosteroid with the long-lasting symptom relief provided by HA in a single injection. The objective of this study was to evaluate the safety and preliminary performance of two new HA formulations, Hydros (hyaluronan-based hydrogel suspended in hyaluronan solution) and Hydros-TA (HA plus 10 mg of triamcinolone acetonide [TA]) in subjects with knee osteoarthritis. Methods We conducted a Phase 2 prospective, multicenter, randomized, double-blind feasibility trial. Participants (n = 98; mean age 60 years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to three treatment groups: Hydros, Hydros-TA, and Synvisc-One® (hylan G-F 20). Participants received one 6 ml intra-articular injection in the treatment knee and were evaluated at 2, 6, 13, and 26 weeks post-treatment. Safety was assessed from adverse events at all study visits. The primary efficacy outcome was the change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (Pain) score for the treatment knee. Results Adverse events were similar across treatment groups with the most common being arthralgia, joint swelling, back pain, and joint stiffness. Arthralgia was reported 5 times with Synvisc-One, 4 with Hydros, and 1 with Hydros-TA. Each group demonstrated a reduction in the WOMAC A (Pain) score over 26 weeks: [least-square mean (standard error)] 30.5 (5.1) mm for Hydros; 34.4 (4.7) mm for Hydros-TA; 28.0 (5.4) mm for Synvisc-One and an observed improvement of 2.5 mm ( p  = 0.64) and 6.4 mm ( p  = 0.24) over Synvisc-One for Hydros and Hydros-TA, respectively. Conclusions A single injection of Hydros or Hydros-TA was well-tolerated and relieved pain associated with knee osteoarthritis over 26 weeks. Data indicate that Hydros-TA had a more rapid pain relief compared to Hydros alone. A Phase 3 trial is underway to confirm these preliminary results. Trial registration number NCT01134406 .

Developing effective therapies against chronic wound healing deficiencies is a global priority. Thus we evaluated the safety of two different doses of topically administered autologous APOSEC, the secretome of apoptotic peripheral blood mononuclear cells (PBMCs), in healthy male volunteers with artificial dermal wounds. Ten healthy men were enrolled in a single-center, randomized, double-blinded, placebo-controlled phase 1 trial. Two artificial wounds at the upper arm were generated using a 4-mm punch biopsy. Each participant was treated with both topically applied APOSEC and placebo in NuGel for 7 consecutive days. The volunteers were randomized into two groups: a low-dose group (A) receiving the supernatant of 12.5 × 10 6 PBMCs and a high-dose group (B) receiving an equivalent of 25 × 10 6 PBMCs resuspended in NuGel Hydrogel. Irradiated medium served as placebo. The primary outcome was the tolerability of the topical application of APOSEC. All adverse events were recorded until 17 days after the biopsy. Local tolerability assessment was measured on a 4-point scale. Secondary outcomes were wound closure and epithelization at day 7. No therapy-related serious adverse events occurred in any of the participants, and both low- and high-dose treatments were well tolerated. Wound closure was not affected by APOSEC therapy.

Introduction and hypothesis Information on urethral bulking therapy in women after previous pelvic radiotherapy is lacking. This study compared the safety and efficacy of polyacrylamide intraurethral injections in patients with and without previous radiotherapy. Methods A total of 46 patients with severe stress urinary incontinence (SUI) were enrolled in this multicenter prospective trial. Group A consisted of 24 patients with previous radiotherapy to the pelvis for the treatment of a gynaecological malignancy. Group B consisted of 22 patients without previous radiotherapy. All patients were treated with a transurethral injection of a bulking solution (Bulkamid). The average follow-up was 12.4 months. The paired Wilcoxon test was used to compare the results before and after the procedure within the groups, and the two-sample Wilcoxon test was used for comparisons between groups. Results Complete continence was achieved in 25 % of patients in group A and in 36.4 % of patients in group B. Significantly reduced urine leakage was observed in both groups ( p  = 0.0164 in group A and p  = 0.0002 in group B). The total scores in the International Consultation on Incontinence Questionnaire decreased by 5.2 in group A ( p  = 0.0000) and 6.36 in group B ( p  = 0.0001). The scores for the Total Patient Perception of Bladder Condition decreased by 1.54 in group A ( p  = 0.0001) and 2.59 in group B ( p  = 0.0000), with a significant difference between groups ( p  = 0.0224). No clinically significant changes in urodynamic parameters were observed. No severe adverse events were noted. Conclusions Based on our results, we conclude that urethral bulking therapy is a valuable treatment option in patients with severe SUI who have undergone pelvic radiotherapy for the treatment of gynaecological malignancy.

Purpose Injection of a hydrogel spacer before prostate cancer radiotherapy (RT) is known to reduce the dose to the rectal wall. Clinical results from the patient’s perspective are needed to better assess a possible benefit. Methods A group of 167 consecutive patients who received prostate RT during the years 2010 to 2013 with 2‑Gy fractions up to 76 Gy (without hydrogel, n  = 66) or 76–80 Gy (with hydrogel, n  = 101) were included. The numbers of interventions resulting from bowel problems during the first 2 years after RT were compared. Patients were surveyed prospectively before RT, at the last day of RT, and at a median of 2 and 17 months after RT using a validated questionnaire (Expanded Prostate Cancer Index Composite). Results Baseline patient characteristics were well balanced. Treatment for bowel symptoms (0 vs. 11 %; p  < 0.01) and endoscopic examinations (3 vs. 19 %; p  < 0.01) were performed less frequently with a spacer. Mean bowel function scores did not change for patients with a spacer in contrast to patients without a spacer (mean decrease of 5 points) >1 year after RT in comparison to baseline, with 0 vs. 12 % reporting a new moderate/big problem with passing stools ( p  < 0.01). Statistically significant differences were found for the items “loose stools”, “bloody stools”, “painful bowel movements” and “frequency of bowel movements”. Conclusion Spacer injection is associated with a significant benefit for patients after prostate cancer RT.

Immunotherapies have revolutionized intervention strategies for many primary cancers, but have not improved the outcomes of glioblastoma multiforme (GBM), which remains one of the most lethal malignant cerebral tumours. Here we present an injectable hydrogel system that stimulates tumoricidal immunity after GBM surgical resection, which mitigates its relapse. The hydrogel comprises a tumour-homing immune nanoregulator, which induces immunogenic cell death and suppression of indoleamine 2,3-dioxygenase-1, and chemotactic CXC chemokine ligand 10, for a sustained T-cell infiltration. When delivered in the resected tumour cavity, the hydrogel system mimics a ‘hot’ tumour-immunity niche for attacking residual tumour cells and significantly suppresses postoperative GBM recurrence. Our work provides an alternative strategy for conferring effective tumoricidal immunity in GBM patients, which may have a broad impact in the immunotherapy of ‘cold’ tumours after surgical intervention. Tumour relapse after resection undermines the efficacy of surgical treatment for glioblastoma multiforme. Here the authors present a hydrogel that can be injected in the tumour cavity after resection and that promotes antitumour immunity, reducing postoperative cancer growth in animal models.

Self-assembling natural drug hydrogels formed without structural modification and able to act as carriers are of interest for biomedical applications. A lack of knowledge about natural drug gels limits there current application. Here, we report on rhein, a herbal natural product, which is directly self-assembled into hydrogels through noncovalent interactions. This hydrogel shows excellent stability, sustained release and reversible stimuli-responses. The hydrogel consists of a three-dimensional nanofiber network that prevents premature degradation. Moreover, it easily enters cells and binds to toll-like receptor 4. This enables rhein hydrogels to significantly dephosphorylate IκBα, inhibiting the nuclear translocation of p65 at the NFκB signalling pathway in lipopolysaccharide-induced BV2 microglia. Subsequently, rhein hydrogels alleviate neuroinflammation with a long-lasting effect and little cytotoxicity compared to the equivalent free-drug in vitro. This study highlights a direct self-assembly hydrogel from natural small molecule as a promising neuroinflammatory therapy. There is interest in the development of drug-based hydrogels for responsive sustained drug release. Here, the authors report on the self-assembly of natural small molecule, rhein, into hydrogels and the application of the hydrogels as stable controlled release agents for neuro-inflammatory therapy