Stem Cell Therapy for Type 2 Diabetes Mellitus

June 10, 2010 updated by: Cellonis Biotechnology Co. Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;
Time Frame: 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.
one year

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Cellonis Biotechnology Co. Ltd.

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 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

June 11, 2010

Last Update Submitted That Met QC Criteria

June 10, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cellonis-CR-2.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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