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Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia

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ClinicalTrials.gov Identifier: NCT01937416
Recruitment Status : Unknown
Verified December 2013 by Quanhai Li, Hebei Medical University.
Recruitment status was:  Recruiting
First Posted : September 9, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Quanhai Li, Hebei Medical University

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

Condition or disease Intervention/treatment Phase
Diabetes Lower Limb Ischemia Biological: autologous bone marrow mononuclear cells Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Investigation of Patients With Diabetic Lower Limb Ischemia by Transplantation of Autologous Bone Marrow Mononuclear Cells
Study Start Date : January 2012
Actual Primary Completion Date : September 2013
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: 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.
Biological: 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.




Primary Outcome Measures :
  1. Cell transplantation related side effect [ Time Frame: 2 week after cell transplantation ]
    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


Secondary Outcome Measures :
  1. ulcer size [ Time Frame: Post cell transplantation: 1, 3, 6 months ]
    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.

  2. rest pain score [ Time Frame: Post cell transplantation: 1,3, 6 months ]

    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.


  3. cold sensation score [ Time Frame: Post cell transplantation: 1,3, 6 months ]

    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.

  4. Resting ABI [ Time Frame: Post cell transplantation: 1,3, 6 months ]
    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.

  5. Resting TcPO2 (mmHg) [ Time Frame: Post cell transplantation:1, 3, 6 months ]
    Transcutaneous oxygen pressure(TcPO2) should be measured at the same site in the ischemic limb at rest.

  6. Collateral vessel score [ Time Frame: Post cell transplantation: 1,3, 6 months ]

    Collateral vessel score: Using computed tomographic angiography to score the collateral vessel formation. A mean score is obtained for each ischemic limb by 3 independent interventionists based on the following 4 level score: 0 (no new collateral vessels)

    1. (A little new collateral vessels)
    2. (moderate new collateral blood vessels)
    3. (Rich new collateral vessels)

  7. Skin microcirculation measurement [ Time Frame: 1,3,6 months post cell transplantation ]
    using PeriMed "laser-Doppler flowmetry" measure the skin microcirculation on the same site in the ischemic limb at rest.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937416


Locations
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China, Hebei
the First Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Xu Han, master    86-311-85917202    hanxu98@126.com   
Sponsors and Collaborators
Hebei Medical University
Investigators
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Study Chair: Baoyong Yan, Doctor The First Hospital of Hebei Medical University
Study Director: Huimin Zhou, doctor The First Hospital of Hebei Medical University
Principal Investigator: Xu Han, master The First Hospital of Hebei Medical University
Principal Investigator: Quanhai Li, doctor The First Hospital of Hebei Medical University

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Responsible Party: Quanhai Li, Director of Cell Thearpy Center, the First Hospital of HeibeiMU, Hebei Medical University
ClinicalTrials.gov Identifier: NCT01937416     History of Changes
Other Study ID Numbers: 12276102D
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
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Ischemia
Pathologic Processes