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Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Critical Limb Ischemia Mesenchymal Stem Cells Umbilical Cord Biological: umbilical cord mesenchymal stem cells Drug: Standard Therapy Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
Study Start Date : January 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: umbilical cord mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
 Biological: umbilical cord mesenchymal stem cells
5*10/7 per ischemic limb
Other Name: mesenchymal stem cells
Active Comparator: Standard Therapy
Any therapy for diabetic foot which is routinely practiced and accepted in China
 Drug: Standard Therapy
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
Other Name: Drug therapy


Outcome Measures
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Primary Outcome Measures :
  1. Angiographic evaluation of angiogenesis at ischemic limb [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pain [ Time Frame: 3 months ]
  2. Ankle-Brachial pressure index [ Time Frame: 3 months ]
  3. Wound healing (wound size, wound stage) [ Time Frame: 3 months ]
  4. Walking distance [ Time Frame: 3 months ]
  5. Rate and extent of amputations [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01216865


Contacts
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Contact: Jianxia Hu, MD 86-0532-82911676 qdyxyhjx@126.com
Contact: Hong Gao, MS 86-0532-82911676 honggaogloria@gmail.com

Locations
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China, Shandong
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Contact: Jianxia Hu, MD    86-0532-82911676    qdyxyhjx@126.com   
Contact: Hong Gao, MS    86-0532-82911676    honggaogloria@gmail.com   
Principal Investigator: Yangang Wang, MD PhD         
Sponsors and Collaborators
Qingdao University
Investigators
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Study Director: Yangang Wang, MD Phd The Affiliated Hospital of Qingdao University
More Information
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Responsible Party: Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT01216865    
Other Study ID Numbers: MSCDF001
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: January 2009
Keywords provided by Qingdao University:
Diabetic foot
critical limb ischemia
mesenchymal stem cells
umbilical cord
Additional relevant MeSH terms:
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Diabetic Foot
Chronic Limb-Threatening Ischemia
Ischemia
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Chronic Disease
Disease Attributes