A Multi-center, Randomized, Independent Evaluator-Subject Blinded, Placebo-Controlled, Phase I/III Clinical Study to Evaluate Safety and Efficacy of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear

Rotator cuff tear is one of the most common shoulder diseases and retears occur frequently after arthroscopic repair. Therefore, there is a growing need of new therapy to improve structural outcome. This study evaluates the efficacy and safety of autologous fibroblasts during arthroscopic repair. The primary outcome is the retear rate at 24 weeks after administration of autologous fibroblasts (TPX-114) during arthroscopic repair. Secondary outcomes are functional evaluations including Range of Motion (ROM), Constant Score (CS), American Shoulder and Elbow Surgeons (ASES) score and Simple Shoulder Test (SST) at 24 and 52 weeks after administration.

开始日期2018-07-09

申办/合作机构

Tego Science, Inc.

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2024-01-12·Stem Cells Translational Medicine

Cell-Based Therapy by Autologous Bone Marrow-Derived Mononuclear Cells for Bone Augmentation of Plate-Stabilized Proximal Humeral Fractures: A Multicentric, Randomized, Open Phase IIa study

Article

作者: Moeck, Vivien ; Eichler, Kathrin ; Horlohé, Kay Hajo Schmidt ; Seifried, Erhard ; Seebach, Caroline ; Bonig, Halvard ; Frischknecht, Nadine ; Bellen, Marlene ; Henrich, Dirk ; Frank, Johannes ; Verboket, Rene ; Nau, Christoph ; Hoffmann, Reinhard ; Marzi, Ingo

AbstractProximal humerus fractures are common in an aging population. The standard operative treatment is open reduction internal fixation (ORIF) using an angular stable plate. However, this procedure has complications such as a relatively high rate of secondary dislocation, humeral head necrosis or nonunion caused by delayed bony consolidation. Autologous bone marrow mononuclear cells (BMC) combined with a β-TCP scaffold could support bone healing and is considered clinically safe.This multicentric, randomized, open phase IIa clinical trial (Clinical Trials. Gov Identifier: NCT02803177, Eudra CT No: 2015-001820-51) evaluated whether autologous BMC with β-TCP in addition to ORIF reduces the incidence of secondary dislocations in patients with proximal humerus fracture. Ninty-four patients equally divided between verum group (BMC+β-TCP) and control group (ß-TCP only) were targeted and calculated. At the time of planned interim evaluation, ie, enrolment of 56 patients, no statistical difference in secondary dislocations or complications was demonstrated in either group after an observation period of 12 weeks. Radiographic bone healing and DASH score to determine shoulder function were comparable between both groups. Bone marrow harvest and BMC transplantation did not result in any severe adverse events. Therefore, the study was terminated after the interim analysis, as no other result could be expected. From the study results, it can be concluded that the application of autologous BMC is well tolerated, and bone healing can be achieved. Augmentation of bone defects with β-TCP could be shown to be feasible and might be considered in other clinical situations.

2023-03-01·The American Journal of Sports Medicine1区 · 医学

Intra-articular Injection of Autologous Adipose-Derived Stem Cells or Stromal Vascular Fractions: Are They Effective for Patients With Knee Osteoarthritis? A Systematic Review With Meta-analysis of Randomized Controlled Trials

1区 · 医学

Review

作者: Kim, Kang-Il ; Kim, Jun-Ho ; Kim, Myung-Seo

Background: Intra-articular injection of adipose-derived stem cells, which are divided into adipose-derived mesenchymal stem cells (ASCs) and adipose-derived stromal vascular fractions (ADSVFs), has been reported to be a viable treatment modality for knee osteoarthritis (OA); however, its efficacy remains limited. Purpose: This study aimed to provide comprehensive information about the efficacy and safety of intra-articular injections of autologous ASCs and ADSVFs without adjuvant treatment in patients with knee OA. Study Design: Meta-analysis; Level of evidence, 1. Methods: A systematic search of the MEDLINE, Embase, Web of Science, and Cochrane Library databases was performed to identify randomized controlled trials (RCTs) that evaluated the efficacy and safety of intra-articular injections of autologous ASCs or ADSVFs without adjuvant treatments compared with placebo or hyaluronic acid in patients with knee OA. Clinically, the 100-mm visual analog scale for pain relief and the Western Ontario and McMaster Universities Osteoarthritis Index for functional improvement were implemented. Radiologically, cartilage status was assessed using magnetic resonance imaging (MRI). Procedure-related knee pain, swelling, and adverse events (AEs) were evaluated for safety. Additionally, we performed subgroup analyses comparing ASCs versus ADSVFs. Methodological quality was assessed using the modified Coleman Methodology Score (mCMS). Results: A total of 5 RCTs were included in this study. Based on the meta-analysis, ASCs or ADSVFs showed significantly better pain relief at 6 months ( Z = 7.62; P < .0001) and 12 months ( Z = 7.21; P < .0001) and functional improvement at 6 months ( Z = 4.13; P < .0001) and 12 months ( Z = 3.79; P = .0002), without a difference in procedure-related knee pain or swelling compared with controls. Although a meta-analysis with regard to cartilage improvements was not performed owing to heterogeneous MRI assessment, 3 studies reported significantly improved cartilage status after the injection. No serious AEs associated with ASCs or ADSVFs were reported. Subgroup analyses showed similar efficacy between ASC and ADSVF treatments. The median mCMS was 70 (range, 55-75). Conclusion: For patients with knee OA, intra-articular injection of autologous ASCs or ADSVFs without adjuvant treatment showed remarkable clinical efficacy and safety at short-term follow-up. Some degree of efficacy has been shown for cartilage regeneration in knee OA, although the evidence remains limited. Further RCTs that directly compare ASCs and ADSVFs are needed.

2022-07-01·Dermatology and Therapy

Leg Ulcer Therapy by Local Injection of Autologous Growth Factors: Results of a Pilot Study

Article

作者: Džupa, Valér ; Whitley, Adam ; Gkalpakiotis, Spyridon ; Šíma, Petr

INTRODUCTIONPopulation ageing has led to an increase in the prevalence of many chronic diseases that occur in elderly patients including chronic wounds of various aetiologies, especially leg ulcers. The treatment of these wounds is lengthy and associated with health, economic and social problems. The aim of our study was to compare the outcomes of local injections of autologous growth factors with standard dressings for leg ulcer treatment.METHODSThe study included 25 patients with leg ulcers treated with autologous growth factors, and 15 patients treated with standard wet dressings only. The area and depth of ulcers were measured on days 0, 5, 28, 84 and 168, and statistically processed using the chi-square test, the Fischer exact test, the Wilcoxon two-sample test, the non-parametric paired Wilcoxon test and the Friedman analysis of variance (ANOVA) test at a significance level of 5%.RESULTSArea and depth did not significantly differ between the two groups before initiation of the treatment (p = 0.472 and p = 0.242, respectively). During the study period, the average leg ulcer area decreased in both the study and control groups by 72% and 40%, respectively. The paired Wilcoxon test showed that this decrease was significant in the study group (p < 0.001), but not in the control group (p = 0.075).CONCLUSIONLeg ulcers heal better when treated with autologous growth factor injections than when treated with standard dressings alone. A further study with a larger number of patients is needed to confirm the presented results. However, this method seems to be a promising way to treat ulcers of the lower extremities.

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