A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus

Cellonis Biotechnology Co. Ltd.1 site in 1 country24 target enrollmentAugust 2010

ConditionsType 1 Diabetes Mellitus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: Cellonis Biotechnology Co. Ltd.
Enrollment: 24
Locations: 1
Primary Endpoint: Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus

Detailed Description

To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

December 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cellonis Biotechnology Co. Ltd.

Eligibility Criteria

Inclusion Criteria

•Free will taking part in the study and ability to provide written informed consent.
•Confirmed diagnosis of type I diabetes for at least 2 years
•Insulin-dependent.
•Age 18-50 years, Male/Female.
•FBG≥7.0 mmol/L, and HbAc1≥7％.
•Not pregnant or nursing.
•Negative pregnancy test.
•Fertile patients will use effective contraception.

Exclusion Criteria

•Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
•Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
•Active infection requiring treatment.
•Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.

Outcomes

Primary Outcomes

Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.

Time Frame: 1 year

Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.