Yang Rong, Zhang Yonggang, Liao Xiaoyang, Guo Ru, Yao Yi, Huang Chuanying, Qi Li
Department of International Medical Center/Ward of General Practice, West China Hospital, Sichuan University, Chengdu, China.
Department of Periodical Press and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.
Front Cardiovasc Med. 2021 Jul 8;8:630231. doi: 10.3389/fcvm.2021.630231. eCollection 2021.
It is important to register clinical trials before their implementation. There is a lack of study to evaluate registered clinical trials of stem cell therapy for heart diseases. Our study used the registration information at ClinicalTrials.gov to provide an overview of the registered trials investigating stem cell therapy for heart diseases. We searched ClinicalTrials.gov from inception to October 1, 2020 to identify clinical trials evaluating stem cell therapy for heart diseases. These trials were included in a cross-sectional survey and descriptive analysis. The outcomes included start date, completion date, location, status, study results, funding, phase, study design, conditions, interventions, sex, age, and sample size of those trials, as well as conditions, efficacy, safety and samples of the publications. SPSS 24.0 software was used for the statistical analysis. A total of 241 trials were included. The registration applications for most trials originated from the United States, and the research start date ranged from 2001 to 2025. More than half of the trials have been completed, but few trials have published results (15.62%). The funding source for 81.12% of trials was recorded as "other" because the specific funding source was not indicated. There were 226 (93.78%) interventional studies and 15 (6.22%) observational studies; among all 241 studies, only 2.90% were phase 4 trials. Most interventional studies used randomized allocation, parallel assignment, and blinding. Of the observational studies, 6 were cohort studies (40.00%) and 73.33% were prospective. The most common disease was coronary artery disease (57.68%) and 98.34% included both male and female participants. The sample size included fewer than 50 patients in 58.51% of trials, and only 18 trials (7.47%) lasted more than 121 months. The registered details were illogical for nine trials (3.8%) that included 0 subjects and two trials (0.8%) that had a duration of 0 months (0.8%). In term of publications of the trials, most of the publications of the trials showed efficacy and safety in stem cell therapy for heart disease. The clinical trials investigating stem cell therapy for heart diseases registered at ClinicalTrials.gov are mostly interventional studies, and only a few are phase 4 trials. Most trials have a small sample size, and few have a duration of more than 121 months. Most of the completed trials did not publish their results, and some of the registration information was incomplete and illogical.
在临床试验实施前进行注册很重要。目前缺乏对已注册的心脏病干细胞治疗临床试验的评估研究。我们的研究利用ClinicalTrials.gov上的注册信息，对已注册的心脏病干细胞治疗试验进行概述。我们检索了ClinicalTrials.gov自成立至2020年10月1日的信息，以识别评估心脏病干细胞治疗的临床试验。这些试验纳入横断面调查和描述性分析。结果包括那些试验的开始日期、完成日期、地点、状态、研究结果、资金、阶段、研究设计、疾病、干预措施、性别、年龄和样本量，以及出版物的疾病、疗效、安全性和样本。使用SPSS 24.0软件进行统计分析。共纳入241项试验。大多数试验的注册申请来自美国，研究开始日期为2001年至2025年。超过一半的试验已经完成，但很少有试验发表结果（15.62%）。81.12%试验的资金来源记录为“其他”，因为未指明具体资金来源。有226项（93.78%）干预性研究和15项（6.22%）观察性研究；在所有241项研究中，只有2.90%为4期试验。大多数干预性研究采用随机分配、平行分组和盲法。在观察性研究中，6项为队列研究（40.00%），73.33%为前瞻性研究。最常见的疾病是冠状动脉疾病（57.68%），98.34%的试验纳入了男性和女性参与者。58.51%试验的样本量少于50例患者，只有18项试验（7.47%）持续时间超过121个月。9项试验（3.8%）的注册细节不合逻辑，包括0名受试者，2项试验（0.8%）的持续时间为0个月（0.8%）。就试验的出版物而言，大多数试验出版物显示了干细胞治疗心脏病的疗效和安全性。在ClinicalTrials.gov上注册的心脏病干细胞治疗临床试验大多为干预性研究，只有少数是4期试验。大多数试验样本量小，很少有试验持续时间超过121个月。大多数已完成的试验未发表结果，一些注册信息不完整且不合逻辑。
