Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: BMMCT

• Registration Number: NCT01677013
• Lead Sponsor: Peking University Aerospace Centre Hospital

Brief Summary

The study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

Detailed Description

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-31
• Primary Completion: 2015-05
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-30
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1026

Inclusion Criteria

• Type 2 diabetes mellitus
• age 30-70
• stable doses of medication for at least 3 months
• BMI <35 and >18.5

Exclusion Criteria

• secondary cause for hyperglycemia
• pregnancy or nursing
• positive autoimmune antibody of diabetes
• severe complication or concurrent diseases
• active infection or febrile illness
• allergy to iodine
• history or signs of aortic aneurysm
• history or active pancreatic diseases
• known substance abuse or alcoholism or heavy smoking
• not suitable for other conditions upon investigators' expertise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral medication plus insulin plus BMMCT	BMMCT	Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.
Oral medication plus BMMCT	BMMCT	Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.

Primary Outcome Measures

Name	Time	Method
C-peptide	1 year

Secondary Outcome Measures

Name	Time	Method
HbA1c	1 year
adverse event	1 year
reduction of medication	1 year

Trial Locations

Locations (1)

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital; 🇨🇳 Beijing, Beijing, China