【Patient Recruitment】Clinical Recruitment for Stem‑Cell Therapy of Type 2 Diabetes Mellitus

【患者招募】2 型糖尿病干细胞治疗临床招募

【Patient Recruitment】Clinical Recruitment for Stem‑Cell Therapy of Type 2 Diabetes Mellitus

尊敬的受试者朋友：

Dear Prospective Participants,

中山大学附属第一医院正在开展的 “评价 E10I 治疗 2 型糖尿病的安全性、耐受性以及初步有效性的 I 期临床研究”。本研究试验用药人脐带间充质干细胞注射液 (代号：E10I) 尚未上市，目前已获得国家药品监督管理局和中山大学附属第一医院伦理委员会的批准，计划招募在饮食和运动基础上，经标准治疗后血糖仍控制不佳的难治型 2 型糖尿病受试者 36 例，经筛选评估后评估符合要求的受试者有机会参与到该项临床研究中。

The First Affiliated Hospital of Sun Yat‑sen University is conducting “Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of E10I in the Treatment of Type 2 Diabetes Mellitus”. The investigational product of this study, Human Umbilical Cord‑Derived Mesenchymal Stem Cell Injection (Code: E10I), is not yet marketed. This study has been approved by the National Medical Products Administration and the Ethics Committee of The First Affiliated Hospital of Sun Yat‑sen University. A total of 36 subjects with refractory type 2 diabetes mellitus whose blood glucose remains poorly controlled despite standard treatment on the basis of diet and exercise will be recruited. Eligible subjects after screening and assessment will have the opportunity to participate in this clinical study.

申办方： Sponsors:

广州达博生物制品有限公司 Guangzhou Doublle Bioproduct Co., Ltd. 创智行 (广州) 生物科技有限公司 Chuangzhihang (Guangzhou) Biotechnology Co., Ltd.

治疗方案简介：Brief Introduction to Treatment Regimen:

药物名称：Drug Name:

人脐带间充质干细胞注射液 (代号：E10I) Human Umbilical Cord‑Derived Mesenchymal Stem Cell Injection (Code: E10I)

本研究为多中心、随机化、双盲、安慰剂平行对照设计的 I 期剂量递增试验和扩展研究。分为两部分，第一部分为单次给药，剂量递增试验;第二部分扩展研究，为选定剂量、多次给药的研究。

This is a multi‑center, randomized, double‑blind, placebo‑parallel‑controlled Phase I dose‑escalation trial and extension study. It consists of two parts: Part I is a single‑dose dose‑escalation trial; Part II is an extension study with multiple administrations at selected doses.

第一部分总入组人数 24 例，试验组和安慰剂组按 3:1 随机入组，按剂量递增原则从低剂量至高剂量开展单次给药试验;第二部分总入组人数 12 例，试验组和安慰剂组按 1:1 随机入组，暂定每 2 周给药一次 (D1、D15)，28 天为一个治疗周期，共进行 2 个治疗周期的研究。

In Part I, 24 subjects will be enrolled in a 3:1 randomization ratio between the experimental group and placebo group, receiving single‑dose administrations from low to high dose following dose‑escalation principles. In Part II, 12 subjects will be enrolled in a 1:1 randomization ratio between the experimental group and placebo group. Tentatively, administrations will be given every two weeks (Day 1. Day 15). Each treatment cycle lasts 28 days, with a total of 2 treatment cycles.

试验组使用人脐带间充质干细胞注射液治疗;安慰剂组使用等体积 1% 人血白蛋白注射液。

The experimental group will receive Human Umbilical Cord‑Derived Mesenchymal Stem Cell Injection; the placebo group will receive an equal volume of 1% Human Albumin Injection.

纳入标准：(部分) Inclusion Criteria: (Partial List)

■年龄 18‑80 周岁;

■ Aged 18‑80 years old;

■根据 1999 年 WHO 糖尿病诊断标准，确诊为 2 型糖尿病患者，且病程≥10 年;

■ Confirmed diagnosis of type 2 diabetes mellitus per the 1999 WHO diagnostic criteria, with disease duration ≥ 10 years;

■筛选时，空腹 C 肽 < 1.2 nmol/L; ■ Fasting C‑peptide < 1.2 nmol/L at screening;

■女性受试者体重≥45kg，男性受试者体重≥50kg，且 18.5kg/m²≤BMI≤28.0 kg/m²

■ Female subjects ≥ 45 kg, male subjects ≥ 50 kg; 18.5 kg/m² ≤ BMI ≤ 28.0 kg/m².

排除标准：(部分) Exclusion Criteria: (Partial List)

■诊断为 1 型糖尿病，或特殊类型糖尿病;

■ Diagnosed with type 1 diabetes mellitus or other specific‑types of diabetes;

■急性或慢性胰腺炎;

■ Acute or chronic pancreatitis;

■严重过敏体质、或对药物中的任何成分 (如人血白蛋白、右旋糖酐、二甲基亚砜等) 过敏;

■ Severe allergic diathesis, or allergy to any component of the study drug (e.g. human albumin, dextran, dimethyl sulfoxide, etc.);

■筛选时存在糖尿病急性并发症如酮症酸中毒 (DKA)、高血糖高渗状态 (HHS)、或乳酸性酸中毒病史等，或出现严重糖尿病并发症，如视网膜病变进入增殖期、神经病变有痛性神经病变、血管病变阻塞程度超过 50% 等。

■ Presence of acute diabetic complications at screening including diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), history of lactic acidosis, etc.; or severe diabetic complications such as proliferative retinopathy, painful neuropathy, vascular obstruction > 50%, etc.

申请入口 Application Entry：https://www.gzdoublle.com/lczm.html

Tel: +86 18529065540

联系方式： Contact Information:

联系人：李助理  Contact: Assistant Li

研究中心：中山大学附属第一医院 Study Center: The First Affiliated Hospital of Sun Yat‑sen University

联系地址：广东省广州市越秀区中山二路 58 号 Address: No. 58 Second Zhongshan Road, Yuexiu District, Guangzhou City, Guangdong Province

研究医生：刘娟副主任医师 Investigator: Associate Chief Physician Liu Juan

研究医生出诊时间：星期一 / 星期四下午 星期日上午 Clinic Hours: Monday afternoon, Thursday afternoon, Sunday morning

注：以上报名条件是否符合所有入选条件，最终将由诊治医师决定。

Note: Whether you satisfy all eligibility criteria shall be ultimately determined by the treating physician.