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Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia

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ClinicalTrials.gov Identifier: NCT02089828
Recruitment Status : Unknown
Verified April 2016 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : March 18, 2014
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral blood mononuclear cells in treatment of critical limb ischemia

Condition or disease Intervention/treatment Phase
Thromboangiitis Obliterans Arteritis Peripheral Arterial Disease Other: autologous purified CD34+ cells Other: autologous peripheral blood mononuclear cells Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Control Trial on Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia
Study Start Date : March 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: autologous purified CD34+ cell
transplantation of autologous purified CD34+ cell
Other: autologous purified CD34+ cells
Active Comparator: autologous PB-MNC
transplantation of autologous peripheral blood mononuclear cells
Other: autologous peripheral blood mononuclear cells



Primary Outcome Measures :
  1. major-amputation-free survival rate [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. improvement on transcutaneous partial oxygen pressure [ Time Frame: at 3 months ]

Other Outcome Measures:
  1. improvement on peak pain-free walking time [ Time Frame: at 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rutherford scale of 4-5
  • thromboangiitis obliterans, peripheral arterial disease, or arteritis caused by other etiologies, such as collagen diseases
  • surgical or endovascular procedures are considered unlikely to have successful long-term revascularization, or have failed
  • more than 4 weeks of critical limb ischemia
  • if present, a non-healing ulcer after more than 4 weeks of optimal care by a wound care physician and a nurse

Exclusion Criteria:

  • within 3 months of an acute myocardial infarction
  • any contraindication for the administration of granulocyte colony stimulating factor (G-CSF)

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): NCT02089828


Contacts
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Contact: Zhihui Dong, M.D. 862164041990 ext 2904 dzh926@126.com

Locations
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China
Zhihui Dong Recruiting
Shanghai, China, 200032
Contact: Zhihui Dong, M.D.    862164041990 ext 2904    dzh926@126.com   
Principal Investigator: Weiguo Fu, M.D.         
Principal Investigator: Zhihui Dong, M.D.         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Director: Weiguo Fu, M.D. Fudan University
Principal Investigator: Zhihui Dong, M.D. Fudan University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02089828     History of Changes
Other Study ID Numbers: B2014-021
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteritis
Thromboangiitis Obliterans
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis