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Trial record 1 of 1 for:    NCT03912480
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Stem Cells From Human Exfoliated Teeth in Treatment of Diabetic Patients With Significantly Reduced Islet Function

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ClinicalTrials.gov Identifier: NCT03912480
Recruitment Status : Unknown
Verified April 2019 by CAR-T (Shanghai) Biotechnology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 11, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
CAR-T (Shanghai) Biotechnology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 11, 2019
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE January 5, 2019
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Total daily insulin dose [ Time Frame: baseline and 1,2,6 week and 2,3,6,9,12 month ]
    change from baseline during treatment
  • glucose-c peptide release test [ Time Frame: baseline and 1,2,6 week and 2,3,6,9,12 month ]
    relative baseline change during treatment
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Total daily insulin dose [ Time Frame: 4 year ]
    change from baseline during treatment
  • glucose-c peptide release test [ Time Frame: 4 year ]
    relative baseline change during treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Islet function [ Time Frame: 1 year ]
    c-peptide and proinsulin
  • Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia [ Time Frame: 1 year ]
    Changes relative to baseline during treatment
  • Continuous dynamic blood glucose [ Time Frame: 1 year ]
    Changes relative to baseline during treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cells From Human Exfoliated Teeth in Treatment of Diabetic Patients With Significantly Reduced Islet Function
Official Title  ICMJE Study on the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in Treating Diabetic Patients With Significantly Reduced Islet Function
Brief Summary To evaluate the safety and efficacy of Stem cells from human exfoliated teeth transplantation in patients with Islet function decreased significantly to provides scientific basis for further clinical studies to verify the safety and efficacy. On the basis of maintaining the original treatment, intravenous drip of dental pulp mesenchymal stem cells.
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 0.11IU/kg body weight .

Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment.

Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type1diabetes
Intervention  ICMJE Biological: Stem cells from human exfoliated teeth
Intravenous infusion of pulp mesenchymal stem cells
Study Arms  ICMJE Experimental: Stem cells from human exfoliated teeth

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 0.11IU/kg body weight .

Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment.

Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed.

Intervention: Biological: Stem cells from human exfoliated teeth
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Understand the purpose of clinical trials, willing to participate and sign informed consent;
  2. Patients with type 2 diabetes are clearly diagnosed according to WHO diagnostic criteria and whose disease duration is more than 5 years, or whose disease duration of type 1 diabetes is more than 1 year;
  3. Islet function test (steamed bread test) : c-peptide fasting 1ng/ml, 2 hours 2ng/ml
  4. Insulin (with or without oral hypoglycemic therapy) and fasting blood glucose (FPG)9.0mmol/L, HbAlc 8.5; The service life of oral hypoglycemic drugs (including metformin, alpha-glucosidase inhibitors or insulin secreting agents) was more than 3 months.
  5. Age 25-70 years old, gender not limited;
  6. Body mass index (BMI) : between 19 and 28kg/m2;
  7. from the date of screening to the end of follow-up, male or female subjects of childbearing age will voluntarily take precautions Pregnancy; Urine pregnancy test was negative when screening women of childbearing age, and serum pregnancy test was performed when necessary to clearly exclude pregnancy.-

Exclusion Criteria:

  1. Patients with gestational diabetes or other special types of diabetes;
  2. Acute complications such as diabetic ketoacidosis and non-ketotic hyperosmolar syndrome were screened within the first month;
  3. Patients who have received other stem cell therapy before screening;
  4. Blood pressure of patients with poor blood pressure control: 160/100mmhg at the time of screening;
  5. Those who took thiazolidinediones, ddp-iv inhibitors and glp-1 drugs within the first 3 months were screened;
  6. Patients who have used insulin for less than 1 year before screening and only injected insulin subcutaneously once a day within the past 3 months;
  7. Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors;
  8. Patients with other malignant tumors or suspected tumor tendency;Or in the active phase of various infections (including active stage of HBV or HCV infection);Immunodeficiency virus (HIV) positive patients;
  9. Patients with other serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system, immune system and blood system);
  10. For patients with liver and kidney dysfunction, for example, serum bilirubin TBIL exceeds 1.5 times of the normal upper limit, AST and ALT exceed 2.5 times of the normal upper limit, and serum creatinine Cr exceeds 1.2 times of the normal upper limit;
  11. Is on systemic sex hormone (glucocorticoid), immunosuppressant or cytotoxic therapy;
  12. Disabled patients (blind, deaf, dumb, mentally retarded, physically disabled) as stipulated by law, pregnant women and lactating women;People suffering from mental illness;Patients who take drugs or have a history of adverse drug abuse and alcohol dependence within 5 years;
  13. Patients with contraindications or allergies treated in this study;
  14. Subjects who have participated in other clinical studies in the past 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03912480
Other Study ID Numbers  ICMJE KTLC002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party CAR-T (Shanghai) Biotechnology Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE CAR-T (Shanghai) Biotechnology Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qin Huang, Doctor Changhai houspital
PRS Account CAR-T (Shanghai) Biotechnology Co., Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP