Stem Cells From Human Exfoliated Teeth in Treatment of Type 2 Diabetes

Open, One-arm, Single-center Clinical Study to Evaluate the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in the Treatment of Type 2 Diabetes

To evaluate the safety and efficacy of Stem Cells From Human Exfoliated Teethtransplantation in patients with type 2 diabetes to provides scientific basis for further clinical studies to verify the safety and efficacy of type 2 diabetes.On the basis of maintaining the original treatment, intravenous drip of Stem Cells From Human Exfoliated Teeth.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Biological: Stem Cells From Human Exfoliated Teeth

Detailed Description

Basic treatment:

The original treatment regimen was maintained. During the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped or patients still had frequent hypoglycemia).

Stem cell therapy:

Dosage: Stem Cells From Human Exfoliated Teeth were calculated at 0.1IU/kg body weight .

Course of treatment: 3 times, respectively at the time of enrollment, 1 week after enrollment and 4 weeks after enrollment.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be able to understand the purpose of clinical trial, voluntarily participate in and sign the informed consent;
• Patients with type 2 diabetes WHO were clearly diagnosed according to WHO diagnostic criteria with a course of over 5 years;
• Fasting blood glucose (FPG) was still 7.5-12.0mmol/L and hemoglobin a1c (HbAlc) was still 7.0-10.0% after insulin treatment or combined with oral hypoglycemic drugs; Among them, insulin has been treated for 1 year, and the number of subcutaneous injection is 2 times or more in the last 3 months, and the type and dose of oral hypoglycemic drugs (including metformin only, antinylglycosidase inhibitors or insulin prolactin) have been stable and decreased for 3 months.
• Age 45 to 65 years male and female;
• Body mass index (BMI) between 20 and 30kg/m2;
• Male or Female subjects of childbearing age shall voluntarily take birth control measures from the screening date to the end of the follow-up;Urine pregnancy test was negative during screening of women of reproductive age, and serum pregnancy test was performed when necessary to exclude pregnancy.

Exclusion Criteria:

• Patients with type 1 diabetes, gestational diabetes or other special type of diabetes;
• All kinds of acute complications such as diabetic ketoacidosis and non-ketohyperosmotic syndrome were screened in the first month;
• Patients who had received other stem cell therapy before screening;
• Patients with poorly controlled hypertension had a blood pressure of 160/100mmHg during screening;
• Screening those who had taken thiazolidinedione, DDP-IV inhibitors and GLP-1 drugs within the first 3 months;
• Insulin therapy was used for less than 1 year before screening, and only subcutaneous injection was performed daily for nearly 3 months; One dose insulin;
• Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors;
• Those with other malignant or suspected tumor tendencies;Or in active phase of infection (including hepatitis b or HCV);Immunodeficiency virus (HIV) positive patients;
• Patients suffering from other serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, genitourinary system, immune system and blood system);
• Patients with abnormal liver and kidney function, such as serum bilirubin TBIL exceeding 1.5 times of the normal upper limit, glutamate AST and ALT exceeding 2.5 times of the normal upper limit, and serum creatinine Cr exceeding 1.2 times of the normal upper limit;
• Being treated with systemic sex hormones (glucocorticoids), immunosuppressive or cytotoxic agents;
• Disabled person (blind, deaf, dumb, mentally handicapped, or physically disabled) as prescribed by law, a pregnant and lactating woman;People with mental illness;Patients who have a history of drug abuse or alcohol dependence within 5 years;
• Patients with contraindications or allergies treated in this study;
• Subjects who participated in other clinical studies within the last three months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stem Cells From Human Exfoliated Teeth; According to the weight of 0.1IU /kg with Stem Cells From Human Exfoliated Teeth, three injections will be given respectively at the time of enrollment, one week and four weeks after enrollment.

Biological: Stem Cells From Human Exfoliated Teeth; Basic treatment: The original treatment regimen will be maintained during the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped, but patients still had frequent hypoglycemia). Stem cell therapy: Usage: drip slowly, 50ml normal saline first, then Stem Cells From Human Exfoliated Teeth (during 60 min), then 50ml normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total daily insulin	After treatment total daily insulin dose changes	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbAlc	The proportion of patients with HbA1c < 7.0% and < 6.5%	1 week

Collaborators and Investigators

• Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Qin Huang, Doctor, Changhai houspital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): November 10, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 2, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KTLC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No