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Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

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ClinicalTrials.gov Identifier: NCT01216865
Recruitment Status : Unknown
Verified January 2009 by Qingdao University.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Qingdao University

Tracking Information
First Submitted Date  ICMJE October 6, 2010
First Posted Date  ICMJE October 7, 2010
Last Update Posted Date October 13, 2010
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
Angiographic evaluation of angiogenesis at ischemic limb [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01216865 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2010)
  • Pain [ Time Frame: 3 months ]
  • Ankle-Brachial pressure index [ Time Frame: 3 months ]
  • Wound healing (wound size, wound stage) [ Time Frame: 3 months ]
  • Walking distance [ Time Frame: 3 months ]
  • Rate and extent of amputations [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
Official Title  ICMJE Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
Brief Summary The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.
Detailed Description Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).
Study Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Foot
  • Critical Limb Ischemia
  • Mesenchymal Stem Cells
  • Umbilical Cord
Intervention  ICMJE
  • Biological: umbilical cord mesenchymal stem cells
    5*10/7 per ischemic limb
    Other Name: mesenchymal stem cells
  • Drug: Standard Therapy
    Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
    Other Name: Drug therapy
Study Arms
  • Experimental: umbilical cord mesenchymal stem cells
    Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
    Intervention: Biological: umbilical cord mesenchymal stem cells
  • Active Comparator: Standard Therapy
    Any therapy for diabetic foot which is routinely practiced and accepted in China
    Intervention: Drug: Standard Therapy
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: October 6, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date July 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes mellitus Type 2
  • Age 18 - 75 years
  • Subject has an Ankle-brachial index < 0.9
  • Subject has had previous conservative treatment which resulted in little or no improvement
  • Subject has had no stem cell treatment within the past 6 months
  • No sufficient response to best standard care delivered for six weeks.
  • No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
  • Signed informed consent
  • Absence of life-threatening complications from the ischemic limb
  • Life expectancy more than 2 years
  • Negative pregnancy test when applicable

Exclusion Criteria:

  • Diabetic retinopathy
  • History of neoplasm or hematological disease
  • Uncontrolled high blood pressure (>180/110)
  • Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30%
  • Malignant ventricular arrythmia
  • Deep venous thrombosis during the last 3 months
  • Active bacterial infection
  • Body mass index > 35 Kg/m2
  • Stroke or myocardial infarction during the last 3 months
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers 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 NCT01216865
Other Study ID Numbers  ICMJE MSCDF001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
Study Sponsor  ICMJE Qingdao University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yangang Wang, MD Phd The Affiliated Hospital of Medical College of Qingdao University
PRS Account Qingdao University
Verification Date January 2009

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