Stem Cells From Human Exfoliated Teeth in Treatment of Diabetic Patients With Significantly Reduced Islet Function

NCT03912480 | Unknown Early Phase 1

• 1 other identifier: KTLC002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (2)

• Total daily insulin dose

  change from baseline during treatment

  baseline and 1,2,6 week and 2,3,6,9,12 month

• glucose-c peptide release test

  relative baseline change during treatment

  baseline and 1,2,6 week and 2,3,6,9,12 month

Secondary Outcomes (3)

• Islet function

  1 year

• Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia

  1 year

• Continuous dynamic blood glucose

  1 year

Study Arms (1)

Stem cells from human exfoliated teeth

EXPERIMENTAL

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.

Biological: Stem cells from human exfoliated teeth

Interventions

Stem cells from human exfoliated teeth BIOLOGICAL

Intravenous infusion of pulp mesenchymal stem cells

Stem cells from human exfoliated teeth

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the purpose of clinical trials, willing to participate and sign informed consent;
• 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;
• Islet function test (steamed bread test) : c-peptide fasting 1ng/ml, 2 hours 2ng/ml
• 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.
• Age 25-70 years old, gender not limited;
• Body mass index (BMI) : between 19 and 28kg/m2;
• 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.-

You may not qualify if:

• Patients with gestational diabetes or other special types of diabetes;
• Acute complications such as diabetic ketoacidosis and non-ketotic hyperosmolar syndrome were screened within the first month;
• Patients who have received other stem cell therapy before screening;
• Blood pressure of patients with poor blood pressure control: 160/100mmhg at the time of screening;
• Those who took thiazolidinediones, ddp-iv inhibitors and glp-1 drugs within the first 3 months were screened;
• 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;
• Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors;
• 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;
• 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);
• 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;
• Is on systemic sex hormone (glucocorticoid), immunosuppressant or cytotoxic therapy;
• 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;
• Patients with contraindications or allergies treated in this study;
• Subjects who have participated in other clinical studies in the past 3 months.

Sponsors & Collaborators

• CAR-T (Shanghai) Biotechnology Co., Ltd.: lead

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Qin Huang, Doctor

  Changhai houspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qin Huang, Doctor

CONTACT

13818333125; qxinyi1220@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: January 5, 2019
• Primary Completion: December 30, 2020
• Study Completion: March 31, 2021
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

CN (1)