MedDataX Logo

Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

NCT ID: NCT00465478

Last Updated: 2007-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous bone marrow mononuclear cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shandong University

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Beihua Kong, MD PHD

Role: STUDY_DIRECTOR

Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Li Chen, MD

Role: CONTACT

[email protected]
0086-531-82169408

Xingli Wang, MD PhD

Role: CONTACT

[email protected]
832-355-9939

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Li Chen, MD

Role: primary

[email protected]
0086-531-82169408

Xingli Wang, MD,PhD

Role: backup

[email protected]
832-355-9939

Related Links

Access external resources that provide additional context or updates about the study.

http://www.qiluhospital.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QL060308

Identifier Type: -

Identifier Source: org_study_id