Stem Cell Therapy for Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01143168
• Other study ID #: Cellonis-CR-1.3
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 10, 2010
• Last updated: June 11, 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 Committe
• Study type: Interventional

Clinical Trial 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

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.

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 50 Years

Eligibility

Inclusion Criteria:

1. Free will taking part in the study and ability to provide written informed consent.

2. Confirmed diagnosis of type I diabetes for at least 2 years

3. Insulin-dependent.

4. Age 18-50 years, Male/Female.

5. FBG=7.0 mmol/L, and HbAc1=7%.

6. Not pregnant or nursing.

7. Negative pregnancy test.

8. Fertile patients will use effective contraception.

Exclusion Criteria:

1. Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.

2. Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).

3. Active infection requiring treatment.

4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.

Study Design

Allocation: Non-Randomized, 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 1
• Type 1 Diabetes Mellitus

Intervention

Biological:
• autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs 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	Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.	Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.	1 year	Yes
Secondary	Serious adverse event frequency and severity		1 year	Yes