NCT03658655

Stem Cells From Human Exfoliated Teeth in Treatment of Type 2 Diabetes

Open, One-arm, Single-center Clinical Study to Evaluate the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in the Treatment of Type 2 Diabetes

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of Stem Cells From Human Exfoliated Teethtransplantation 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 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 0.1IU/kg body weight . Course of treatment: 3 times, respectively at the time of enrollment, 1 week after enrollment and 4 weeks after enrollment.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Stem Cells From Human Exfoliated Teeth	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 Stem Cells From Human Exfoliated Teeth (during 60 min), then 50ml normal saline.

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-11-10
• Completion: 2019-11-30
• First posted: 2018-09-05
• Last updated: 2020-02-28

Locations

1 site across 1 country: China