Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

April 24, 2007 updated by: Shandong University

Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 1/2 Study

The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that autologous bone marrow stem cell transplantation will promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulated local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with type 1 or 2 Diabetes mellitus will be recruited according to eligibility criteria. Bone marrow mononuclear cells (BMMCs) will be separated from the bone marrow aspirate of each patient and be directly delivered to pancreas via splenic artery with the distal lumen occlusion through an arterial catheter. All patients will be explained in details about the procedures involved in BMMC transplantation and sign the informed consent for the study; The Ethics Committee of Qilu hospital, ShanDong university approved the treatment protocol. All patients undergo scheduled follow-up evaluations for 5 years after transplantation. Clinical, hematological, metabolical evaluations are performed to analyses the effect of the transplant, Patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and will received the regular OHA and/or insulin therapy .They are followed in parallel with transplanted patients and will be subjected to the same follow-up management including extensive endocrinological monitoring, diet and exercise program as transplantation patients during the follow-up.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 2
  • 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
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Li Chen, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xingli Wang, MD,PhD
        • Principal Investigator:
          • Weikai Hou, MD
        • Principal Investigator:
          • Jianjun Dong, MD
        • Principal Investigator:
          • Kuanxiao Tang, MD,PhD
        • Principal Investigator:
          • Xinguo Hou, MD
        • Principal Investigator:
          • Lei Sun, MD

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

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • Between 16 to 65 years of age
  • Requiring daily exogenous insulin injection for the glycaemic control
  • With poor β-cell function
  • Body mass index (BMI) < 28

Exclusion Criteria:

  • Acute or chronic infections
  • Chronic uncompensated organic insufficiency including heart, liver, renal and lung
  • Any malignancies, congenital or acquired immunodeficiency
  • Hematological diseases or coagulopathy
  • Acute or chronic pancreatitis
  • History of thoracic or abdominal aorta diseases
  • Allergy to iodine
  • Pregnancy

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: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;

Secondary Outcome Measures

Outcome Measure
Safety assessment parameter: amylase, hepatic function,renal function,
lipid profile, autoantibody， Quality of life

Collaborators and Investigators

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

Sponsor

Shandong University

Investigators

  • Study Director: Beihua Kong, MD PHD, Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 1, 2006

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

April 24, 2007

First Submitted That Met QC Criteria

April 24, 2007

First Posted (Estimate)

April 25, 2007

Study Record Updates

Last Update Posted (Estimate)

April 25, 2007

Last Update Submitted That Met QC Criteria

April 24, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL060308

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Autologous bone marrow mononuclear cell transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe