Completed

Bone Marrow Mononuclear Cell Transplantation for Type 2 Diabetes Mellitus

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Study Aim

This study aims to evaluate the safety and effectiveness of Bone Marrow Mononuclear Cell Transplantation as a treatment for Type 2 Diabetes Mellitus, primarily focusing on the changes in your C-peptide levels.

What is being tested

BMMCT

+ BMMCT

Other
Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 30 to 70 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: May 2011
See protocol details

Summary

Principal SponsorPeking University Aerospace Center Hospital
Last updated: October 3, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. According to the intervention and baseline characteristics, patients are divided into 4 arms.

NCT01677013
Principal SponsorPeking University Aerospace Center Hospital
Last updated: October 3, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

1026 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

4 inclusion criteria required to participate
BMI < 35 and > 18.5
Type 2 diabetes mellitus
age 30-70
stable doses of medication for at least 3 months
10 exclusion criteria prevent from participating
active infection or febrile illness
allergy to iodine
history or active pancreatic diseases
history or signs of aortic aneurysm
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
type 2 diabetics with only oral medications

Group II

Experimental
Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.

Group III

No Intervention
Type 2 diabetics who need insulin therapy with oral medications

Group IV

Experimental
Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Beijing, ChinaOpen Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital in Google Maps
CompletedOne Study Center