Stem Cell Therapy for Type 1 Diabetes Mellitus

Phase 1

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT01143168
• Lead Sponsor: Cellonis Biotechnology Co. Ltd.

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.

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-11
• Last Update Submitted: 2010-06-11
• Study First Posted: 2010-06-14
• Last Update Posted: 2010-06-14
• 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. 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serious adverse event frequency and severity	1 year

Trial Locations

Locations (1)

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