NCT00465478

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

April 24, 2007

Last Update Submit

April 24, 2007

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Keywords

Diabetes MellitusBone Marros Mononuclear CellsTransplantation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Safety assessment parameter: amylase, hepatic function,renal function,

  • lipid profile, autoantibody， Quality of life

Interventions

Autologous bone marrow mononuclear cell transplantationPROCEDURE

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Beihua Kong, MD PHD

    Shandong University

    STUDY DIRECTOR

Central Study Contacts

Li Chen, MD

CONTACT

0086-531-82169408chenli3@medmail.com.cn

Xingli Wang, MD PhD

CONTACT

832-355-9939xlwang@bcm.tmc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 25, 2007

Study Start

March 1, 2006

Study Completion

March 1, 2014

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

CN(1)