Conundrum of mechanical knee symptoms: signifying feature of a meniscal tear?

2018 ◽  
Vol 53 (5) ◽  
pp. 299-303 ◽  
Author(s):  
Jonas Bloch Thorlund ◽  
Kenneth Pihl ◽  
Nis Nissen ◽  
Uffe Jørgensen ◽  
Jakob Vium Fristed ◽  
...  
Keyword(s):  
Knee Arthroscopy ◽  
Meniscal Tear ◽  
Prevalence Ratio ◽  
Trial Registration ◽  
Baseline Questionnaire ◽  
Link Type ◽  
Patient Reported ◽  
Registration Number ◽  
Meniscal Surgery

BackgroundMechanical knee symptoms are often considered important in the decision to perform knee arthroscopy on the suspicion of a meniscal tear. We investigated if presence of a meniscal tear at knee arthroscopy in adults is associated with presence of preoperative self-reported mechanical knee symptoms.MethodsWe used data from Knee Arthroscopy Cohort Southern Denmark (KACS). KACS consists of patients aged 18 years or older referred to knee arthroscopy on the suspicion of a meniscal tear at four recruiting hospitals between 1 February 2013 and 31 January 2015. Of 1259 invited patients, 908 (72%) replied to the baseline questionnaire. With 91 patients excluded, the study sample consisted of 641 and 176 patientswithandwithouta meniscal tear confirmed at surgery, respectively. Exposure was meniscal tear as determined by the knee surgeon during arthroscopy. Main outcomes were preoperative mechanical knee symptoms defined as self-reported catching/locking or self-reported inability to straighten knee fully.Results55% of all patients reported symptoms of catching/locking and 47% were unable to straighten their knee fully. Preoperative mechanical symptoms were equally prevalent in patientswithandwithouta meniscal tear (prevalence ratio catching/locking 0.89, 95% CI 0.77 to 1.03, and inability to straighten knee fully, prevalence ratio 1.02, 95% CI 0.84 to 1.23).InterpretationPatient-reported mechanical symptoms were equally common irrespective of presence or absence of a meniscal tear in patients undergoing arthroscopy for suspicion of a meniscal tear. Our findings suggest that mechanical knee symptoms have a limited value when considering indication for meniscal surgery.Trial registration numberNCT01871272; Results.

scholarly journals Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis

2020 ◽  
Vol 5 (4) ◽  
pp. 348-352
Author(s):  
Yi Dong ◽  
Ye Han ◽  
Haipeng Shen ◽  
Yilong Wang ◽  
Frank Ma ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Acute Ischaemic Stroke ◽  
Standard Dose ◽  
Trial Registration ◽  
Comparable Efficacy ◽  
Link Type ◽  
Tissue Plasminogen ◽  
Registration Number

BackgroundThe risk of symptomatic intracranial haemorrhage (sICH) after thrombolysis is low but severe. Lower dose of alteplase may reduce the risk of sICH. We aim to identify subsets of patients who could benefit from lower dose of alteplase compared with standard dose.MethodsData from two observational registries were pooled together. A total of 3479 patients who had acute ischaemic stroke were entered into the interaction tree model. The response variable was the rate of sICH per the definition of the National Institute of Neurological Disorders and Stroke Study. Clinical improvement was measured by the National Institutes of Health Stroke Scale (NIHSS) and defined as NIHSS 0 or 1 or an improvement of more than 4 points (within 7 days or at discharge). Rare event logistic regression was performed to analyse the OR of safety outcome.ResultsTo optimise the interaction effect between tissue plasminogen activator (tPA) dosage (standard/lower) and patient subgroups, three subgroups based on the severity of stroke were identified: (1) NIHSS ≤4, (2) NIHSS between 5 and 14, and (3) NIHSS ≥15. The estimated difference of OR of having sICH was 2.71 (95% CI 0.80 to 7.69, p=0.10) for mild, 0.13 (95% CI 0.02 to 0.68, p=0.01) for moderate, and 0.65 (95% CI 0.19 to 2.55, p=0.52) for severe, respectively. In addition, patients who had moderate stroke treated with lower dose had comparable efficacy outcome (OR 1.23, 95% CI 0.71 to 2.13, p=0.45).ConclusionOur analysis demonstrated that in patients who had moderate stroke, lower doses of alteplase are associated with significant sICH reduction and non-inferior performance in efficacy, compared with those in the standard dose group.Trial registration numberThe TIMS-China was a national prospective stroke registry on thrombolytic therapy using intravenous tPA in patients who had acute ischaemic stroke. The results were initially published in 2012 without a clinical trial registration number. The Shanghai Stroke Service System was registered at www.clinicaltrial.gov (NCT02735226).

scholarly journals Implementing two-stage consent pathway in neonatal trials

2021 ◽  
pp. fetalneonatal-2021-322960
Author(s):  
Eleanor Mitchell ◽  
Sam J Oddie ◽  
Jon Dorling ◽  
Chris Gale ◽  
Mark John Johnson ◽  
...  
Keyword(s):  
Critical Period ◽  
Trial Registration ◽  
Two Stage ◽  
Trial Team ◽  
Link Type ◽  
National Guidance ◽  
Registration Number ◽  
Time Critical

Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042.

scholarly journals Waterpipe device cleaning practices and disposal of waste associated with waterpipe tobacco smoking in homes in the USA

2019 ◽  
Vol 29 (Suppl 2) ◽  
pp. s123-s130 ◽  
Author(s):  
Nada OF Kassem ◽  
Noura O Kassem ◽  
Sandy Liles ◽  
Erin Reilly ◽  
Flora Kas-Petrus ◽  
...  
Keyword(s):  
Tobacco Smoking ◽  
Home Visit ◽  
Trial Registration ◽  
Convenience Sample ◽  
Link Type ◽  
Waterpipe Tobacco Smoking ◽  
Registration Number ◽  
The Usa ◽  
Research Assistants ◽  
Self Administered Questionnaire

ObjectivesTo quantify postsmoking waterpipe tobacco (WPT) waste and describe postsmoking waterpipe (WP) device cleaning practices and disposal of associated waste in home settings.MethodsWe analysed data from a US convenience sample of 50 exclusive WPT smokers, mean age 25.3 years. Data were collected at a home visit during which participants smoked one WPT head and completed a self-administered questionnaire on WP cleaning practices and disposal of waste associated with WPT use. Research assistants provided and prepared a WP for participants by weighing and loading 10 g of WPT in the WP head and placing 470 mL of water in the WP bowl. At the completion of the smoking session, research assistants measured the remaining WPT and water. Descriptive analyses were performed.ResultsOf the 10 g of fresh WPT used for each smoking session, 70.1% (mean=7.01 g) was discarded postsmoking as waste; for each 470 mL of water used in the WP bowl, 94.3% (mean=443 mL) was discarded. WP device cleaning practices ranged from never cleaning the device to cleaning it after each smoking session. Respondents reported discarding smoked WPT residue in the trash (81.6%) or the kitchen sink (14.3%) and discarding postsmoking charcoal in the trash (57.6%), the kitchen sink (27.3%) or backyard soil (9.1%). Respondents reported discarding smoked WP water in the kitchen sink (76.5%), bathroom sink (14.7%), toilet (2.9%) and backyard soil (5.9%).ConclusionsInterventions and regulations are needed to inform proper WP device cleaning practices and disposal of waste associated with WPT use.Trial registration numberNCT03253653.

scholarly journals The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yama Afghanyar ◽  
Sebastian Joser ◽  
Jonas Tecle ◽  
Philipp Drees ◽  
Jens Dargel ◽  
...  
Keyword(s):  
Vitamin E ◽  
Weight Bearing ◽  
Trial Registration ◽  
Harris Hip Score ◽  
Full Weight Bearing ◽  
Link Type ◽  
Radiological Data ◽  
Registration Number ◽  
The Mean

Abstract Background The newest generation of cementless titanium-coated, isoelastic monoblock cup with vitamin E-blended highly cross-linked polyethylene (HXLPE) was introduced to the market in 2009. The aim of the present study was to obtain mid-term follow-up data including migration and wear analyses. Methods This prospective study investigated 101 primary total hip arthroplasty (THA) cases in 96 patients treated at a single institution. Patients were allowed full weight-bearing on the first day postoperatively. Harris hip score (HHS) and pain and satisfication on a visual analogue scale (VAS) were assessed at a mean follow-up of 79.0 months. Migration and wear were assessed using Einzel-Bild-Roentgen-Analyse (EBRA) software. Radiological acetabular bone alterations and complications were documented. Results At mid-term follow-up (mean 79.0 months, range: 51.8–101.7), 81 cases with complete clinical and radiological data were analyzed. Utilisable EBRA measurements were obtained for 42 hips. The mean HHS was 91.1 (range 38.0–100.0), VAS satisfaction was 9.6 (range 6.0–10.0), VAS rest pain was 0.2 (range 0.0–4.0), and VAS load pain was 0.6 (range 0.0–9.0). Mean migration was 0.86 mm (range: 0.0–2.56) at 24 months and 1.34 mm (range: 0.09–3.14) at 5 years, and the mean annual migration rate was 0.22 (range: − 0.24–1.34). The mean total wear was 0.4 mm (range: 0.03–1.0), corresponding to a mean annual wear rate of 0.06 mm per year (range: 0.0–0.17). Radiographic analysis did not reveal any cases of osteolysis, and no revision surgeries had to be performed. Conclusions After using vitamin-E blended HXLPE in cementless isoelastic monoblock cups, there were no obvious signs of osteolysis or aseptic loosening occurred. No patients required revision surgery after mid-term follow-up. Cup migration and wear values were well below the benchmarks considered predictive for potential future failure. Trial registration The trial registration number on ClinicalTrials.gov: NCT04322916 (retrospectively registered at 26.03.2020).

scholarly journals Wild goose chase – no predictable patient subgroups benefit from meniscal surgery: patient-reported outcomes of 641 patients 1 year after surgery

2019 ◽  
Vol 54 (1) ◽  
pp. 13-22 ◽  
Author(s):  
Kenneth Pihl ◽  
Joie Ensor ◽  
George Peat ◽  
Martin Englund ◽  
Stefan Lohmander ◽  
...  
Keyword(s):  
Predictive Performance ◽  
Change Score ◽  
Patient Reported Outcome ◽  
Favourable Outcome ◽  
Average Score ◽  
Surgery Patient ◽  
Patient Reported ◽  
Registration Number ◽  
Meniscal Surgery ◽  
Preoperative Factors

BackgroundDespite absence of evidence of a clinical benefit of arthroscopic partial meniscectomy (APM), many surgeons claim that subgroups of patients benefit from APM.ObjectiveWe developed a prognostic model predicting change in patient-reported outcome 1 year following arthroscopic meniscal surgery to identify such subgroups.MethodsWe included 641 patients (age 48.7 years (SD 13), 56% men) undergoing arthroscopic meniscal surgery from the Knee Arthroscopy Cohort Southern Denmark. 18 preoperative factors identified from literature and/or orthopaedic surgeons (patient demographics, medical history, symptom onset and duration, knee-related symptoms, etc) were combined in a multivariable linear regression model. The outcome was change in Knee injury and Osteoarthritis Outcome Score (KOOS4) (average score of 4 of 5 KOOS subscales excluding the activities of daily living subscale) from presurgery to 52 weeks after surgery. A positive KOOS4change score constitutes improvement. Prognostic performance was assessed using R2statistics and calibration plots and was internally validated by adjusting for optimism using 1000 bootstrap samples.ResultsPatients improved on average 18.6 (SD 19.7, range −38.0 to 87.8) in KOOS4. The strongest prognostic factors for improvement were (1) no previous meniscal surgery on index knee and (2) more severe preoperative knee-related symptoms. The model’s overall predictive performance was low (apparent R2=0.162, optimism adjusted R2=0.080) and it showed poor calibration (calibration-in-the-large=0.205, calibration slope=0.772).ConclusionDespite combining a large number of preoperative factors presumed clinically relevant, change in patient-reported outcome 1 year following meniscal surgery was not predictable. This essentially quashes the existence of ‘subgroups’ with certain characteristics having a particularly favourable outcome after meniscal surgery.Trial registration numberNCT01871272.

scholarly journals Phase II study of stereotactic body radiotherapy with hydrogel spacer for prostate cancer: acute toxicity and propensity score-matched comparison

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Mami Ogita ◽  
Hideomi Yamashita ◽  
Yuki Nozawa ◽  
Sho Ozaki ◽  
Subaru Sawayanagi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Propensity Score ◽  
Acute Toxicity ◽  
Phase Ii ◽  
Stereotactic Body Radiotherapy ◽  
Phase Ii Study ◽  
Summary Score ◽  
Trial Registration ◽  
Gu Toxicity ◽  
Patient Reported

Abstract Background The efficacy of a hydrogel spacer in stereotactic body radiotherapy (SBRT) has not been clarified. We evaluated the safety and efficacy of SBRT in combination with a hydrogel spacer for prostate cancer. Methods This is a prospective single-center, single-arm phase II study. Prostate cancer patients without lymph node or distant metastasis were eligible. All patients received a hydrogel spacer insertion, followed by SBRT of 36.25 Gy in 5 fractions with volumetric modulated arc therapy. The primary endpoint was physician-assessed acute gastrointestinal (GI) toxicity within 3 months. The secondary endpoints were physician-assessed acute genitourinary (GU) toxicity, patient-reported outcomes evaluated by the EPIC and FACT-P questionnaires, and dosimetric comparison. We used propensity score-matched analyses to compare patients with the hydrogel spacer with those without the spacer. The historical data of the control without a hydrogel spacer was obtained from our hospital’s electronic records. Results Forty patients were enrolled between February 2017 and July 2018. A hydrogel spacer significantly reduced the dose to the rectum. Grade 2 acute GI and GU toxicity occurred in seven (18%) and 17 (44%) patients. The EPIC bowel and urinary summary score declined from the baseline to the first month (P < 0.01, < 0.01), yet it was still significantly lower in the third month (P < 0.01, P = 0.04). For propensity score-matched analyses, no significant differences in acute GI and GU toxicity were observed between the two groups. The EPIC bowel summary score was significantly better in the spacer group at 1 month (82.2 in the spacer group and 68.5 in the control group). Conclusions SBRT with a hydrogel spacer had the dosimetric benefits of reducing the rectal doses. The use of the hydrogel spacer did not reduce physician-assessed acute toxicity, but it improved patient-reported acute bowel toxicity. Trial registration: Trial registration: UMIN-CTR, UMIN000026213. Registered 19 February 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385.

scholarly journals Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial

2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Iñaki Pastor-Pons ◽  
María Orosia Lucha-López ◽  
Marta Barrau-Lalmolda ◽  
Iñaki Rodes-Pastor ◽  
Ángel Luis Rodríguez-Fernández ◽  
...  
Keyword(s):  
Manual Therapy ◽  
Education Program ◽  
Controlled Trial ◽  
Asymmetry Index ◽  
Trial Registration ◽  
Control Group ◽  
Parental Perception ◽  
Positional Plagiocephaly ◽  
Caregiver Education ◽  
Registration Number

Abstract Background Positional plagiocephaly frequently affects healthy babies. It is hypothesized that manual therapy tailored to pediatrics is more effective in improving plagiocephalic cranial asymmetry than just repositioning and sensory and motor stimulation. Methods Thirty-four neurologically healthy subjects aged less than 28 weeks old with a difference of at least 5 mm between cranial diagonal diameters were randomly distributed into 2 groups. For 10 weeks, the pediatric integrative manual therapy (PIMT) group received manual therapy plus a caregiver education program, while the controls received the same education program exclusively. Cranial shape was evaluated using anthropometry; cranial index (CI) and cranial vault asymmetry index (CVAI) were calculated. Parental perception of change was assessed using a visual analogue scale (− 10 cm to + 10 cm). Results CVAI presented a greater decrease in PIMT group: 3.72 ± 1.40% compared with 0.34 ± 1.72% in the control group (p = 0.000). CI did not present significant differences between groups. Manual therapy led to a more positive parental perception of cranial changes (manual therapy: 6.66 ± 2.07 cm; control: 4.25 ± 2.31 cm; p = 0.004). Conclusion Manual therapy plus a caregiver education program improved CVAI and led to parental satisfaction more effectively than solely a caregiver education program. Trial registration Trial registration number: NCT03659032; registration date: September 1, 2018. Retrospectively registered.

scholarly journals MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mohamad Hadi El Charif ◽  
Samer Doughan ◽  
Rawya Kredly ◽  
Sara Kassas ◽  
Rayan Azab ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Wound Healing ◽  
Anal Fissure ◽  
Topical Therapy ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Anal Fissures ◽  
Link Type ◽  
Anorectal Region ◽  
Registration Date

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

scholarly journals SAT0121 PAIN AND OTHER PATIENT-REPORTED OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO DID OR DID NOT ACHIEVE TREATMENT RESPONSE BASED ON IMPROVEMENT IN SWOLLEN JOINTS IN TOCILIZUMAB CLINICAL TRIALS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 994.2-995
Author(s):  
A. Sebba ◽  
J. Han ◽  
S. Mohan
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Pain Score ◽  
Patient Reported Outcomes ◽  
Component Score ◽  
Link Type ◽  
Pain Scores ◽  
Sf 36 ◽  
Patient Reported ◽  
Nonresponder Group

Background:Significant improvements in pain and other patient-reported outcomes (PROs) have been shown in large clinical trials in patients with rheumatoid arthritis (RA) who receive tocilizumab (TCZ) compared with placebo (PBO). Recent data suggest that pain in RA may be noninflammatory as well as inflammatory, and improvement in pain scores and other PROs may be seen in patients who do not respond to treatment based on disease activity measures that evaluate inflammation.Objectives:To assess changes in pain scores and other PROs in patients with RA who did or did not achieve ≥ 20% improvement in SJC in TCZ clinical trials.Methods:Data from patients with active RA who received intravenous TCZ 8 mg/kg + MTX or PBO + MTX in 3 Phase III studies (OPTION [NCT00106548], TOWARD [NCT00106574] and LITHE [NCT00109408]) were included. All patients had moderate to severe RA with an inadequate response or intolerance of MTX (OPTION, LITHE) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TOWARD). Changes in pain (visual analog scale [VAS], 0-100 mm), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3), 36-Item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS; 0-50) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (0-52) from baseline to Week 24 were evaluated. Results were compared between patients receiving TCZ + MTX and those receiving PBO + MTX in both patients who achieved ≥ 20% improvement in SJC (responders) and those who did not (nonresponders). The changes from baseline were analyzed using a mixed model with repeated measures, including the following covariates and interactions: treatment, visit, baseline of endpoint, region, baseline DAS28 and interactions of visit with treatment and baseline of endpoint.Results:Data from 1254 responders (TCZ + MTX, n = 831; PBO + MTX, n = 423) and 620 nonresponders (TCZ + MTX, n = 225; PBO + MTX, n = 395) were included. Patients receiving TCZ + MTX had significantly greater improvement in pain scores and HAQ-DI compared with PBO + MTX in the responder group (–27.19 vs –16.77 and –0.55 vs –0.34, respectively;P< 0.0001 for both) and nonresponder group (–9.59 vs 2.53 and –0.20 vs 0.01;P< 0.0001 for both) at Week 24 (Figure 1). Similar results were seen at Week 16 in the nonresponder group (–11.06 vs –2.38 and –0.23 vs –0.04;P< 0.0001 for both) prior to initiation of rescue treatment. At Week 24 in the responder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS and MCS (9.16 vs 5.71 and 6.55 vs 3.79, respectively;P< 0.0001 for both) (Figure 2) and FACIT-Fatigue (8.39 vs 5.11;P< 0.0001). In the nonresponder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS at Week 16 (3.81 vs 1.65;P= 0.0006) and Week 24 (4.42 vs 1.01;P< 0.0001) (Figure 2) and FACIT-Fatigue at Week 16 (3.82 vs 1.32;P= 0.0039) and Week 24 (3.90 vs 1.40;P= 0.0111).Conclusion:Patients with RA who received TCZ + MTX had significantly greater improvements in pain score and other PROs than those who received PBO + MTX regardless of whether they achieved ≥ 20% improvement in SJC. Clinical outcome at Week 24 correlated well with PROs, with a relatively larger improvement in pain score and other PROs in the responder group than in the nonresponder group; relative to PBO + MTX, these improvements appear numerically similar in the responder and nonresponder groups with consistently smaller difference between the groups in TCZ-treated arms. The consistent effect of TCZ on PROs in both responder and nonresponder groups warrants further study on the impact of TCZ on sources of pain independent of that caused by joint inflammation.Figure:Acknowledgments:This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests:Anthony Sebba Consultant of: Genentech, Gilead, Lilly, Regeneron Pharmaceuticals Inc., Sanofi, Speakers bureau: Lilly, Roche, Sanofi, Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Shalini Mohan Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.

scholarly journals A novel MSC-based immune induction strategy for ABO-incompatible liver transplantation: a phase I/II randomized, open-label, controlled trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Yingcai Zhang ◽  
Jiebin Zhang ◽  
Huimin Yi ◽  
Jun Zheng ◽  
Jianye Cai ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Hepatic Failure ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Trial Registration ◽  
Biliary Complications ◽  
Open Label ◽  
Antibody Mediated Rejection ◽  
Link Type ◽  
Induction Strategy

Abstract Background ABO-incompatible liver transplantation (ABO-i LT) has become a rescue therapeutic option for patients with severe hepatic failure. Although the use of rituximab greatly reduces the morbidity of antibody-mediated rejection (AMR), severe adverse effects, such as infection and biliary complications, still seriously threaten the survival of transplant recipients. The aim of this study was to evaluate the safety and feasibility of using mesenchymal stem cells (MSCs) to replace rituximab in ABO-i LT. Methods Twenty-two patients with severe hepatic failure undergoing ABO-i LT were enrolled and randomly divided into two groups: the MSC group and the rituximab group. The safety of the application of MSCs and the incidence of allograft rejection, including antibody-mediated rejection (AMR) and acute cellular rejection (ACR), were evaluated in both groups at the 2-year follow-up period as primary endpoints. Recipients and graft survival and other postoperative complications were compared as secondary endpoints. Results No severe MSC-related adverse events were observed during the trial. MSC treatment yielded comparable, if not better, results than rituximab at decreasing the incidence of acute rejection (9.1% vs 27.3%). Inspiringly, compared to those in the rituximab group, the rates of biliary complications (0% vs 45.5%) and infection (9.1% vs 81.8%) were significantly decreased in the MSC group. In addition, there were no significant differences in 2-year graft and recipient survival between the two groups (81.8% vs 72.7%). Conclusions Our data show that MSC transfusion is comparable to rituximab treatment for AMR prophylaxis following ABO-i LT. Additionally, the results indicate that MSCs are more beneficial to the prevention of infection and biliary complications and may be introduced as a novel immunosuppressive approach for ABO-i LT. Trial registration Trial registration: chictr.org.cn, ChiCTR2000037732. Registered 31 August 2020- Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=57074.

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