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

Peking University Aerospace Centre Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: BMMCT

Study type: Interventional

Funder types: Other

Identifiers

NCT01677013

PUACH-721002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,026 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,026 participants in 4 patient groups

Oral medication treatment

No Intervention group

Description:

type 2 diabetics with only oral medications

Oral medication plus BMMCT

Experimental group

Description:

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

Treatment:

Other: BMMCT

Oral medication plus insulin treatment

No Intervention group

Description:

Type 2 diabetics who need insulin therapy with oral medications

Oral medication plus insulin plus BMMCT

Experimental group

Description:

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

Treatment:

Other: BMMCT