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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type1diabetes	Biological: Stem cells from human exfoliated teeth	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: 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study on the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in Treating Diabetic Patients With Significantly Reduced Islet Function
• Actual Study Start Date: January 5, 2019
• Estimated Primary Completion Date: December 30, 2020
• Estimated Study Completion Date: March 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Total daily insulin dose [ Time Frame: baseline and 1,2,6 week and 2,3,6,9,12 month ]
   change from baseline during treatment
2. 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

Secondary Outcome Measures :

1. Islet function [ Time Frame: 1 year ]
   c-peptide and proinsulin
2. Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia [ Time Frame: 1 year ]
   Changes relative to baseline during treatment
3. Continuous dynamic blood glucose [ Time Frame: 1 year ]
   Changes relative to baseline during treatment

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Qin Huang, Doctor; 13818333125; qxinyi1220@163.com

Locations

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

• Principal Investigator: Qin Huang, Doctor; Changhai houspital

More Information

• Responsible Party: CAR-T (Shanghai) Biotechnology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03912480
• Other Study ID Numbers: KTLC002
• First Posted: April 11, 2019
• Last Update Posted: April 22, 2019
• Last Verified: April 2019

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

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases