Stem Cell Therapy for Type 2 Diabetes Mellitus

Phase 1

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT01142050
• Lead Sponsor: Cellonis Biotechnology Co. Ltd.

Brief Summary

The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.

Detailed Description

* To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.

* To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Last Update Submitted: 2010-06-10
• Study First Posted: 2010-06-11
• Last Update Posted: 2010-06-11
• Study Start: 2010-08
• Primary Completion: 2011-08
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Free will taking part in the study and ability to provide written informed consent;
2. Type 2 diabetes mellitus (as guideline WHO, 1999);
3. Age 18-75 years old，Male/Female;
4. 19≤Body mass index (BMI)≤30㎏/㎡;
5. Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;
6. Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;
7. Not pregnant or nursing;
8. Negative pregnancy test;
9. Fertile patients will use effective contraception.

Exclusion Criteria

1. Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
2. Active infection requiring treatment;
3. Unexplained febrile illness;
4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;	one year	1. Insulin resistance index indicated by ITT change compared with baseline.; 2. Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline.; 3. Hemoglobin A1c.; 4. Fast blood glucose (FBG) and Postmeal blood glucose (PBG).; 5. C-peptide levels.; 6. Serum Insulin levels.

Secondary Outcome Measures

Name	Time	Method
Serious adverse event frequency and severity	one year

Trial Locations

Locations (1)

Armed Police General Hospital, P.R. China; 🇨🇳 Beijing, China