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Dental Medullary Mesenchymal Stem Cells in Treatment of Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03658655
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
CAR-T (Shanghai) Biotechnology Co., Ltd.

Brief Summary:
To evaluate the safety and efficacy of dental pulp mesenchymal stem cells transplantation 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 dental pulp mesenchymal stem cells.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Biological: Dental pulp mesenchymal stem cells Early Phase 1

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: pulp mesenchymal stem cells 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open, One-arm, Single-center Clinical Study to Evaluate the Efficacy and Safety of Dental Medullary Mesenchymal Stem Cells in the Treatment of Type 2 Diabetes
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dental pulp mesenchymal stem cells
According to the weight of 0.1IU /kg with Dental pulp mesenchymal stem cells, three injections will be given respectively at the time of enrollment, one week and four weeks after enrollment.
Biological: Dental pulp mesenchymal stem cells

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 pulp mesenchymal stem cells (during 60 min), then 50ml normal saline.





Primary Outcome Measures :
  1. Total daily insulin [ Time Frame: 1 week ]
    After treatment total daily insulin dose changes


Secondary Outcome Measures :
  1. HbAlc [ Time Frame: 1 week ]
    The proportion of patients with HbA1c < 7.0% and < 6.5%



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658655


Contacts
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Contact: Qin Huang, Doctor 86-13818333125 qxinyi1220@163.com
Contact: Jingyun Song 86-13795368981

Locations
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China, Shanghai
Changhai hospital Recruiting
Shanghai, Shanghai, China
Contact: Qin Huang, Doctor    +86 13818333125    qxinyi1220@163.com   
Sponsors and Collaborators
CAR-T (Shanghai) Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Qin Huang, Doctor Changhai houspital

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Responsible Party: CAR-T (Shanghai) Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03658655     History of Changes
Other Study ID Numbers: KTLC001
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases