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Safety and Efficacy of Kartigen^® in Treating Cartilage Defects: A Randomized, Controlled, Phase I Trial.

ABSTRACT: Here, we aimed to investigate the safety and preliminary efficacy of Kartigen^®, a matrix with autologous bone marrow mesenchymal stem cell-derived chondrocyte precursors embedded in atelocollagen. As a surgical graft, Kartigen^® was implanted onto the cartilage defects at the weight-bearing site of the medial femoral condyle of the knee. Fifteen patients were enrolled and stratified into two groups, undergoing either Kartigen^® implantation (n = 10) or microfracture (control group, n = 5). The primary endpoint was to evaluate the safety of Kartigen^® by monitoring the occurrence of adverse events through physician queries, physical examinations, laboratory tests, and radiological analyses for 2 years. There were no infections, inflammations, adhesions, loose body, or tumor formations in the Kartigen^®-implanted knees. The preliminary efficacy was assessed using the International Knee Documentation Committee (IKDC) score, visual analog scale, and second-look arthroscopy. The postoperative IKDC scores of the Kartigen^® group significantly improved in the 16th week (IKDC = 62.1 ± 12.8, p = 0.025), kept increasing in the first year (IKDC = 78.2 ± 15.4, p < 0.005), and remained satisfactory in the second year (IKDC = 73.6 ± 13.8, p < 0.005), compared to the preoperative condition (IKDC = 47.1 ± 17.0), while the postoperative IKDC scores of the control group also achieved significant improvement in the 28th week (IKDC = 68.5 ± 6.1, p = 0.032) versus preoperative state (IKDC = 54.0 ± 9.1). However, the IKDC scores decreased in the first year (IKDC = 63.5 ± 11.6) as well as in the second year (IKDC = 52.6 ± 16.4). Thirteen patients underwent second-look arthroscopy and biopsy one year after the operation. The Kartigen^® group exhibited integration between Kartigen^® and host tissue with a smooth appearance at the recipient site, whereas the microfracture group showed fibrillated surfaces. The histological and immunohistochemical analyses of biopsy specimens demonstrated the columnar structure of articular cartilage and existence of collagen type II and glycosaminoglycan mimic hyaline cartilage. This study indicates that Kartigen^® is safe and effective in treating cartilage defects.

SUBMITTER: Liu YL

PROVIDER: S-EPMC8466236 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundHigh-intensity repetitive task-specific practice might be the most effective strategy to promote motor recovery after stroke, and electromechanical-assisted gait training represents one of the treatment options. However, there is still difficulty in clarifying the difference between conventional gait training and electromechanically assisted gait training.MethodsThe study is a multicenter, randomized, parallel-group clinical trial for stroke patients. Three clinical research centers in Korea (Dongguk University Ilsan Hospital, Chungnam National University Hospital, and Seoul National University Bundang Hospital) will participate in the clinical trial and 144 stroke patients will be registered. Enrolled patients are assigned to two groups, an experimental group and a control group, according to a randomization table. In addition, patients are treated for half an hour (one session) five times a week for 4 weeks. Both groups carry out basic rehabilitation (central nervous system development therapy and strength exercise) and the experimental group executes robotic walking rehabilitation treatment, and the control group executes conventional gait rehabilitation treatment. The primary endpoint variable is the Functional Ambulation Category (FAC) that determines the degree of independent walking and is measured before, after, and after 4 weeks of treatment. Secondary endpoint variables are 11 variables that take into account motor function and range, measured at the same time as the primary endpoint variable.DiscussionThere are still insufficient data on the effectiveness of electromechanical-assisted gait training for stroke patients and large-scale research is lacking. Thus, the research described here is a large-scale study of stroke patients that can supplement the limitations mentioned in other previous studies. In addition, the clinical studies described here include physical epidemiological analysis parameters that can determine walking ability. The results of this study can lead to prove the generalizable effectiveness and safety of electromechanical-assisted gait training with EXOWALK®.Trial registrationClinical Research Information Service (CRIS), Republic of Korea KCT0003411, Registered on 30 October 2018.

Project description:Background There is no clear evidence-based medicine that points to the most effective drug treatments for the common cold. In view of its ability to relieve symptoms and shorten the disease course, as well as its minimal side effects, traditional Chinese medicine (TCM) has been widely used to treat the common cold. However, there is a lack of strong evidence to support the clinical efficacy of TCM. This study aimed to evaluate the efficacy and safety of Ganduqing granules in the treatment of the common cold based on the network pharmacology analysis. Methods In this multicenter, randomized, double-blind, placebo-controlled trial, 60 eligible subjects will be randomly assigned to either the intervention group or the placebo group. The intervention group will be treated with Ganduqing granules, while the placebo group will be treated with placebo. After 5 days of intervention, the efficacy and safety of Ganduqing granules in the treatment of the common cold will be observed. The primary outcome is the time to clearance of all symptoms. The secondary outcomes included the levels of IL-6, TNF-α, SOD, and MDA in the peripheral blood, time to disappearance of primary symptoms and secondary symptoms, clinical symptom remission rate, and change in TCM syndrome score. Results Sixty participants completed the study. Ganduqing granules showed a greater effect on the time to clearance of all symptoms (P < 0.0001), nasal discharge (P=0.0124), fatigue and lack of strength (P=0.0138), dryness of the pharynx (P < 0.0001), pharyngalgia or dysphagia (P < 0.0001), and expectoration (P < 0.0431) compared with the placebo group. Participants in the intervention group had a greater decrease of IL-6 levels compared with the placebo group (P < 0.007); similar results were observed for the SOD (P < 0.033). However, the change in TNF-α and MDA levels in the intervention group was not significantly different from the placebo group. In addition, participants in the intervention group had a greater decrease of TCM syndrome score compared with the placebo group (P < 0.040). Conclusion Ganduqing granules could improve common cold symptoms, shorten the disease course, attenuated inflammation and oxidative stress, and provided objective evidence for the efficacy and safety of a Chinese herbal medicine in treating the common cold.

Project description:Objective:To evaluate the efficacy of electroacupuncture (EA) on treating insomnia in patients with depression. Patients and Methods:In a patient-assessor-blind, randomized and sham controlled trial, 90 depression patients with insomnia were assigned into three different groups, receiving EA in the treatment group, superficial acupuncture at sham points in the control group A, or Streitberger non-insertion sham acupuncture in the control group B. Treatment was applied 3 times weekly for 8 consecutive weeks. The primary outcome was measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes were sleep parameters including sleep efficiency (SE), total sleep time (TST) and numbers of sleep awakenings (SA) recorded in the actigraphy, as well as applying the Hamilton Rating Scale for Depression (HAMD-17), Self-Rating Depression Scale (SDS) and Hamilton Rating Scale for Anxiety (HAMA). Assessments were performed at the baseline (week 0), week 4, week 8, and week 12. Linear mixed-effects models were used for analyses and all statistical tests were two-sided. Results:Patients in the EA group had more significant improvement in PSQI scores than those in the control groups over time (respectively p<0.001 and p=0.04 for treatment and time interaction). At 8-week posttreatment, the EA group reported a reduction of -6.64 points in PSQI scores compared with -2.23 points in the control group A (95% CI= -5.74 to -2.39) and -2.94 points in the control group B (95% CI= -5.73 to -2.47). Compared with the two control groups, significant between-group differences were seen in SE (both p<0.01) and TST (both p<0.01) at week 8; similar results can be found in HAMD-17, SDS, and HAMA scores as well. However, there were no between-group differences in SA (respectively p=0.24 and p=0.08) after 8-weeks of treatment. Conclusion:Electroacupuncture may improve the sleep quality of patients with depression. Trial Registration:Chinese Clinical Trial Registry (ChiCTR); URL: http://www.chictr.org.cn/showproj.aspx?proj=12327; Trial ID: ChiCTR-IIR-16008058.

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Safety and Efficacy of Kartigen^® in Treating Cartilage Defects: A Randomized, Controlled, Phase I Trial.

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Safety and Efficacy of Kartigen® in Treating Cartilage Defects: A Randomized, Controlled, Phase I Trial.

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OmicsDI is part of the ELIXIR infrastructure

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Safety and Efficacy of Kartigen^® in Treating Cartilage Defects: A Randomized, Controlled, Phase I Trial.