Stem Cell Therapy for Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01142050
• Other study ID #: Cellonis-CR-2.3
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 10, 2010
• Last updated: June 10, 2010
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2010
• Source: Cellonis Biotechnology Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Biological:
• mesenchymal stem cells
1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.

Locations

Country	Name	City	State
China	Armed Police General Hospital, P.R. China	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cellonis Biotechnology Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;	Insulin resistance index indicated by ITT change compared with baseline.; Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline.; Hemoglobin A1c.; Fast blood glucose (FBG) and Postmeal blood glucose (PBG).; C-peptide levels.; Serum Insulin levels.	one year	Yes
Secondary	Serious adverse event frequency and severity		one year	Yes