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

Study on the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in Treating Diabetic Patients With Significantly Reduced Islet Function

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.

Study Overview

• Status: Unknown
• Conditions: Type1diabetes
• 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 0.11IU/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: Interventional
• Enrollment (Anticipated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Qin Huang, Doctor; Phone Number: 13818333125; Email: qxinyi1220@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Changhai Hospital
      • Contact: Qin Huang, Doctor; Phone Number: +86 13818333125; Email: qxinyi1220@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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; 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; Intravenous infusion of pulp mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Islet function	c-peptide and proinsulin	1 year
Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia	Changes relative to baseline during treatment	1 year
Continuous dynamic blood glucose	Changes relative to baseline during treatment	1 year

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): January 5, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: KTLC002

Drug and device information, study documents

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