Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia

Hebei Medical University

Status and phase: Unknown; Phase 1

Conditions: Diabetes; Lower Limb Ischemia

Treatments: Biological: autologous bone marrow mononuclear cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01937416

12276102D

Details and patient eligibility

About

This study is to evaluate the safety and efficacy of autologous bone marrow mononuclear cells transplantation in diabetic patients with lower limb ischemia.

Full description

Diabetic lower limb ischemia as severe complication of diabetes influences the life quality of patients and currently the effective treatment for the disease is lacking. Bone marrow mononuclear cells have been proved to have multiple functions including the differentiation and proliferation. In animal model, bone marrow mononuclear cells could induce angiogenesis and may have therapeutic usage for ischemia disease. The investigators thereby design the study to investigate the possible therapy of diabetic lower limb ischemia with autologous bone marrow mononuclear cells. Patient with diabetic lower limb ischemia was treated with colony stimulating factor for improvement of bone marrow hematopoiesis. Then bone marrow was taken and mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation. Bone marrow mononuclear cells were transplanted into ischemia regions of lower limb through intramuscular injection. The investigators investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, routine analysis of blood and urine etc. post the transplantation. And the efficacy was evaluated with the measurement of ulcer size, rest pain score, cold sensation score, resting ABI, resting TcPO2, collateral vessel score and skin microcirculation.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. fontaine's stage 2-4 or resting ABI <0.7
2. age between 20 and 80 years old
3. sign informed consent, voluntary subjects
4. diagnosis of diabetic lower limb ischemia

Exclusion criteria

1. poorly controlled diabetes (HBA1c> 7.0%) and proliferative retinopathy (III-IV stage)
2. malignancy history in the past five years or serum level of tumor markers elevated more than doubled
3. severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate bone marrow mononuclear cells transplantation
4. serious infections (such as cellulitis, osteomyelitis, etc.)
5. pregnant female, or reproductive age female who wants to give birth throughout the course of the study
6. life expectancy less than half a year

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

autologous bone marrow mononuclear cells

Experimental group

Description:

Bone marrow come from the patients himself/herself. With a conventional method and reagent,Ficoll, mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation.

Treatment:

Biological: autologous bone marrow mononuclear cells