Safety and Efficacy of OCN19-overexpressed Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Refractory Type 2 Diabetes Mellitus

NCT06727721 | Recruiting Phase 2

• 1 other identifier: CHEC2023-226
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Umbilical cord mesenchymal stem cell injection expressing OCN19, while playing the role of MSCs, can directly stimulate the expression of insulin gene and the division and proliferation of islet beta cells, which is expected to further enhance the therapeutic effect of stem cells. In non-clinical studies, it was found that MSCs expressing OCN19 had better hypoglycemic effect than MSCs

Conditions

Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Daily insulin dose is used

  From enrollment to 1 month, 3 months, 6 months and 1 year after treatment

Secondary Outcomes (7)

• Changes in Fasting Blood Glucose Levels Over Time

  From enrollment to 1 month, 3 months, 6 months and 1 year after treatment

• Concentration of Hemoglobin A1c in Participants

  From enrollment to 3 months, 6 months and 1 year after treatment

• Concentration of fasting c-peptide in Participants

  From enrollment to 1 month, 3 months, 6 months and 1 year after treatment

• Concentration of Glycated albumin in Participants

  From enrollment to 1 month, 3 months, 6 months and 1 year after treatment

• Concentration of 2-hour postprandial C-peptide in Participants

  From enrollment to 1 month, 3 months, 6 months and 1 year after treatment

Study Arms (3)

The placebo group

PLACEBO COMPARATOR

The control group was given albumin

Biological: albumin injection

The control group

ACTIVE COMPARATOR

The control group was given mesenchymal stem cells

Biological: Mesenchymal stem cells

The experimental group

EXPERIMENTAL

The experimental group was given OCN-19 stem cells

Biological: mesenchymal stem cells with OCN-19

Interventions

mesenchymal stem cells with OCN-19 BIOLOGICAL

The patient received mesenchymal stem cells with OCN-19 three times

The experimental group

Mesenchymal stem cells BIOLOGICAL

Ordinary mesenchymal stem cells were given

The control group

albumin injection BIOLOGICAL

Placebo

The placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accoding to WHO diagnostic standards, patients with type 2 diabetes (fasting blood glucose ≥ 7.0 mmol/L), 30-75 years old, regardless of gender;
• Able to clearly understand the purpose of clinical trials and comply with trial requirements, willing to participate in this study, and sign an informed consent form;
• kg/m2 ≤ Body Mass Index (BMI) ≤ 30 kg/m2;
• % ≤ glycated hemoglobin ≤ 10%;
• Insulin should be subcutaneously injected for more than six months, and insulin and/or other oral hypoglycemic drugs (limited to metformin only) should be used α The dosage of glycosidase inhibitors remained stable for the first 3 months before randomization;
• During the study period, all males and females with reproductive potential were willing to accept the use of efficient contraceptive methods.

You may not qualify if:

• Type diabetes, pregnancy diabetes or other special type diabetes patients;
• Patients with severe allergic constitution or allergic to any ingredients used in cell culture;
• Patients who have used drugs that affect glucose metabolism within the past month, such as glucocorticoids, thiazide diuretics, oral contraceptives, tricyclic antidepressants, etc;
• Screening the patients with acute complications such as diabetes ketoacidosis and non ketotic hyperosmolar syndrome in recent 6 months;
• Serious cardiovascular and cerebrovascular events such as NYHA grade III or IV heart failure, myocardial infarction, cerebral infarction, and cerebral hemorrhage occurred within the past 6 months;
• Patients with abnormal blood routine (including white blood cell or neutrophil count below the lower limit of normal, abnormal platelet count, and hemorrhagic disease);
• Patients with liver and kidney dysfunction: such as serum bilirubin TBIL exceeding the upper limit of normal by 1.5 times, AST and ALT exceeding the upper limit of normal by 2.5 times, and serum creatinine exceeding 1.5 mg/dl for males and 1.4 mg/dl for females;
• Patients with other serious systemic diseases (such as malignant tumors, central nervous system, cardiovascular system, blood system, digestive system, endocrine system, respiratory system, urogenital system, immune system, etc.);
• Individuals who are currently using systemic hormones (such as glucocorticoids), immunosuppressants, or cytotoxic therapy;
• Patients who received antibiotic treatment within the three months prior to study registration;
• Patients who have received live or attenuated vaccines within 4 weeks prior to registration, or plan to receive live or attenuated vaccines during the study period;
• Patients who are positive for HbsAg, Anti HCV, HIV or syphilis;
• Patients with active infection (such as hepatitis B or hepatitis C, tuberculosis) requiring treatment;
• Fever related diseases of unknown origin;
• Disabled patients (blind, deaf, mute, intellectually disabled, physically disabled) and individuals with mental illnesses;

Sponsors & Collaborators

• Lu jin ，MD: lead

Study Sites (1)

Changhai Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Albumins

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

jin lu

CONTACT

021-18801784133; 18801784133@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of endocrinology Department, Changhai Hospital

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 11, 2024
• Study Start: November 6, 2023
• Primary Completion (Estimated): December 12, 2028
• Study Completion (Estimated): December 12, 2029
• Last Updated: December 17, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)