Skip to main content
OpenTrials
Completed

NCT Number: NCT01677013

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Beijing, Beijing Municipality, 100049, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMMCT

Other

Bone marrow mononuclear cell transplantation via selective catheterization

Other names: Bone marrow mononuclear cell transplantation

Primary outcomes

  1. C-peptide

    Time frame: 1 year

Secondary outcomes

  1. reduction of medication

    Time frame: 1 year

  2. HbA1c

    Time frame: 1 year

  3. adverse event

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Peking University Aerospace Center Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Aug 31, 2012
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.