Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Qingdao University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Qingdao University
ClinicalTrials.gov Identifier:
NCT01216865
First received: October 6, 2010
Last updated: October 12, 2010
Last verified: January 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

Resource links provided by NLM:


Further study details as provided by Qingdao University:

Primary Outcome Measures:
  • Angiographic evaluation of angiogenesis at ischemic limb [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ankle-Brachial pressure index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Wound healing (wound size, wound stage) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Walking distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Rate and extent of amputations [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216865

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

Locations
China, Shandong
Stem Cell Research Center of Medical School Hospital of Qingdao University Not yet recruiting
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
Study Director: Yangang Wang, MD Phd The Affiliated Hospital of Medical College of Qingdao University
  More Information

No publications provided

Responsible Party: Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT01216865     History of Changes
Other Study ID Numbers: MSCDF001
Study First Received: October 6, 2010
Last Updated: October 12, 2010
Health Authority: China: Ministry of Health

Keywords provided by Qingdao University:
Diabetic foot
critical limb ischemia
mesenchymal stem cells
umbilical cord

Additional relevant MeSH terms:
Diabetic Foot
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

ClinicalTrials.gov processed this record on July 28, 2014