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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

Tracking Information
First Submitted Date  ICMJE September 4, 2013
First Posted Date  ICMJE September 9, 2013
Last Update Posted Date December 4, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia
Official Title  ICMJE Safety and Efficacy Investigation of Patients With Diabetic Lower Limb Ischemia by Transplantation of Autologous Bone Marrow Mononuclear Cells
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Lower Limb Ischemia
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: autologous bone marrow mononuclear cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 6, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01937416
Other Study ID Numbers  ICMJE 12276102D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quanhai Li, Hebei Medical University
Study Sponsor  ICMJE Hebei Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hebei Medical University
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP