Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia

Phase 1UnknownNCT01937416

Hebei Medical University10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Lower Limb Ischemia

Interventions

autologous bone marrow mononuclear cellsBIOLOGICAL

Bone marrow was taken from patient oneself 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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Outcomes

Primary Outcomes

Cell transplantation related side effect

Temperature,pulse,respiration,blood pressure,routine analysis of blood and urine, liver function,renal function,function of coagulation, ECG,cell transplantation related death and cell transplantation related unexpected amputation

Time frame: 2 week after cell transplantation

Secondary Outcomes

ulcer size

Measuring ulcer area (cm2) and depth (mm)of limb : For each ulcer , photographically record the area and depth with a ruler in order to calculate the ulcer area in square millimeters.

Time frame: Post cell transplantation: 1, 3, 6 months

rest pain score

Scoring the rest pain based on the degree of pain as following five scales): 0 level-0 point: no pain; 1. level-1 point: occasional pain which can be recalled; 2. level-2 points: the pain often but can be tolerated, without or with a little analgesics; 3. level-3 points: often with need of general analgesics; 4. level -4 points: affect sleeping due to the pain, general pain medication being difficult to alleviate. Before transplantation: points; after transplantation: points.

Time frame: Post cell transplantation: 1,3, 6 months

cold sensation score

based on a sense of cold as following five scales: 0 level-0 point: no cold sensation; 1. level-1 point, or : Occasionally cold feeling; 2. level-2 points: Often with cold feeling; 3. level-3 points: significantly cold feeling. and can be significantly improved when using a local insulation. 4. level-4 points: significantly cold feeling,and can not be significantly improved when using a local insulation.

Time frame: Post cell transplantation: 1,3, 6 months

Resting ABI

Measurement of ABI(ankle brachial index, ABI): Measure arterial pressure with a laser Doppler, and then calculate the ankle-brachial index, that is a ratio of ankle arterial blood pressure to brachial arterial blood pressure at rest.

Data from ClinicalTrials.gov

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