Enrollment Completed for Doublle Bio hUC-MSCs Phase I Low-Dose Group

Spring heralds a new journey, and research leads to great heights! The Phase I clinical trial of the human umbilical cord mesenchymal stem cell injection (E10I) independently developed by Guangzhou Doublle Biological Products Co., Ltd. has successfully completed the enrollment of subjects in the low-dose group, marking a solid and crucial step forward in the clinical research of this project and laying a solid foundation for the advancement of subsequent trials.

This Phase I clinical trial focuses on type 2 diabetes as the indication, with the primary objective of evaluating the safety and tolerability of intravenous infusion of E10I in patients with type 2 diabetes, while also exploring its preliminary efficacy, providing a scientific basis for subsequent dose exploration and clinical application. The trial adopts a standardized clinical design, with three dose groups set at low, medium, and high levels. The successful enrollment of the low-dose group will serve as a core reference for the formulation of subsequent dose escalation strategies and the accumulation of safety data, injecting strong momentum into the overall advancement of the project. It fully validates the scientific nature, ethical compliance, and project execution of the trial protocol.

Based on the safety foundation verified in the low-dose group, and in conjunction with the dose escalation principle preset in the trial protocol, the project will proceed with the recruitment of subjects into the medium and high-dose groups in an orderly manner. The detailed inclusion and exclusion criteria (partially), as well as the research centers and contact information, are provided below.

The successful completion of the enrollment in the low-dose group is inseparable from the dedicated efforts and unwavering trust of all clinical researchers, subjects, and project team members. Dabo Biotech will always prioritize the safety of subjects and the quality of clinical data as its two core focuses, steadily advance the trial process, accelerate the pace of results transformation, and strive to bring better medical solutions to patients at an early date!

[Inclusion Criteria] (Part)

■ Age: 18-80 years old;

■ According to the 1999 WHO diagnostic criteria for diabetes, the patient is diagnosed with type 2 diabetes and has had the disease for ≥10 years;

■ During screening, diet and exercise control were implemented according to the requirements of the Chinese Diabetes Prevention and Treatment Guidelines (2024 edition). At least three oral hypoglycemic agents or insulin combined with at least two oral hypoglycemic agents (oral drug doses were at standard doses or maximum tolerated doses, with a treatment duration of at least three months) were used, and blood glucose control was poor (HbA1c ≥ 7.0%).

■ During screening, the fasting C-peptide level should be less than 1.2 nmol/L;

■Female subjects must weigh ≥45kg, while male subjects must weigh ≥50kg, and have a BMI ranging from 18.5kg/㎡ to 28.0 kg/㎡.

[Exclusion Criteria] (Partially)

■ Diagnosed with type 1 diabetes, or a specific type of diabetes;

■ Acute or chronic pancreatitis;

■Severe allergic constitution, or allergy to any ingredient in the medication (such as human albumin, dextran, dimethyl sulfoxide, etc.);

■ During screening, there is a history of acute diabetic complications such as diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), or lactic acidosis, or severe diabetic complications, such as vascular lesions with obstruction exceeding 50% (to be determined by the investigator).

Participating hospitals

The First Affiliated Hospital of Sun Yat-sen University

Contact: Assistant Li

Contact number: 13392620374

The Second Affiliated Hospital of Guangzhou Medical University

Contact: Assistant Ling

Contact number: 18329937511

Union Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology

Contact: Assistant Wang

Contact number: 15042405411

Friendly reminder: If you use the same number for WeChat, please contact us on working days

We are looking forward to your participation!