Human Umbilical Cord Mesenchymal Stem Cell Injection for Diabetic Nephropathy
报名条件(概要)
- 年龄:30 Years – 70 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
UC-MSCs :5\*10E5、1\*10E6、2\*10E6 UC-MSCs/kg body weight/100mL saline containing 1% human albumin
saline containing 1% human albumin/100mL
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
合作机构
- Wuhan Hamilton Biotechnology Co., Ltd.企业
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
Diabetic nephropathy (DN) is one of the most significant microvascular complications of diabetes mellitus. Its incidence can reach 30%-40% after 20 years of diabetes duration, among which 5%-10% of patients will progress to end-stage renal disease, where renal function is essentially lost, and only hemodialysis or kidney transplantation can sustain or save lives. Given the current lack of effective clinical measures for treating diabetic nephropathy, exploring new strategies for its prevention and treatment is of great significance. Diabetic nephropathy is caused by persistent hyperglycemia, and its key pathological features include chronic inflammatory cell infiltration in kidney tissue, podocyte apoptosis in the glomeruli, pyroptosis of renal tubular epithelial cells, and renal fibrosis. Therefore, the key to treating diabetic nephropathy lies in inhibiting chronic renal inflammation and alleviating the resulting tissue and cell damage; reducing glomerular podocyte apoptosis and renal tubular epithelial cell pyroptosis, lowering proteinuria levels, and delaying the pathological progression of diabetic nephropathy; suppressing renal fibrosis; and regenerating new renal tissue cells to partially restore renal tissue structure and function. Current clinical treatments for diabetic nephropathy primarily involve strict glycemic control and the use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists. Numerous clinical studies have shown that these therapeutic measures can only partially delay the onset and slow the progression of diabetic nephropathy, but cannot reverse renal damage. Accumulating evidence indicates that mesenchymal stem cells (MSCs) can migrate and home to injured kidney tissues, directionally differentiate into renal parenchymal cells to repair and regenerate damaged tissue cells; secrete nutritional factors to improve local blood supply and the microenvironment of renal tissue; and release anti-inflammatory and immunomodulatory factors, exerting potent anti-inflammatory and immunomodulatory effects, thereby reducing inflammatory injury and apoptosis of renal tissue cells and alleviating renal fibrosis. Therefore, mesenchymal stem cells have emerged as a new hope for the treatment of diabetic nephropathy.
适应症
主动联系研究团队
总联系人(申办方/研究总部)
中国/港澳台研究中心
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, WUHAN, HUBEIWuhan,China
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Human Umbilical Cord Mesenchymal Stem Cell Injection for Diabetic Nephropathy ClinicalTrials.gov Identifier: NCT07822152 Sponsor: Tongji Hospital Investigational product: UC-MSCs, Placebo About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Human Umbilical Cord Mesenchymal Stem Cell Injection for Diabetic Nephropathy 试验编号:NCT07822152 申办方:Tongji Hospital 研究药物:UC-MSCs、Placebo 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。