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Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia

NCT ID: NCT01937416

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Lower Limb Ischemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous bone marrow mononuclear cells

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.

Group Type EXPERIMENTAL

autologous bone marrow mononuclear cells

Intervention Type BIOLOGICAL

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.

Interventions

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autologous bone marrow mononuclear cells

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Quanhai Li

Director of Cell Thearpy Center, the First Hospital of HeibeiMU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baoyong Yan, Doctor

Role: STUDY_CHAIR

The First Hospital of Hebei Medical University

Huimin Zhou, doctor

Role: STUDY_DIRECTOR

The First Hospital of Hebei Medical University

Xu Han, master

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Hebei Medical University

Quanhai Li, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Hebei Medical University

Locations

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the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xu Han, master

Role: primary

Other Identifiers

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12276102D

Identifier Type: -

Identifier Source: org_study_id