Stem Cell Therapy for Type 1 Diabetes Mellitus

June 11, 2010 updated by: Cellonis Biotechnology Co. Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Type 1 Diabetes Mellitus

Intervention / Treatment

Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells

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 Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Beijing, China, 100085
    - Armed Police General Hospital, P. R. China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Serious adverse event frequency and severity Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellonis Biotechnology Co. Ltd.

Investigators

Principal Investigator: Shi X Y, M.D., Armed Police General Hospital, P. R. China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (ESTIMATE)

June 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)