Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia
NCT ID: NCT02089828
Last Updated: 2016-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2014-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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autologous purified CD34+ cell
transplantation of autologous purified CD34+ cell
autologous purified CD34+ cells
autologous PB-MNC
transplantation of autologous peripheral blood mononuclear cells
autologous peripheral blood mononuclear cells
Interventions
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autologous purified CD34+ cells
autologous peripheral blood mononuclear cells
Eligibility Criteria
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Inclusion Criteria
* 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
* any contraindication for the administration of granulocyte colony stimulating factor (G-CSF)
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Weiguo Fu, M.D.
Role: STUDY_DIRECTOR
Fudan University
Zhihui Dong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhihui Dong
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Dong Z, Chen B, Fu W, Wang Y, Guo D, Wei Z, Xu X, Mendelsohn FO. Transplantation of purified CD34+ cells in the treatment of critical limb ischemia. J Vasc Surg. 2013 Aug;58(2):404-411.e3. doi: 10.1016/j.jvs.2013.01.037. Epub 2013 Apr 21.
Liu H, Pan T, Liu Y, Fang Y, Fang G, Jiang X, Chen B, Wei Z, Gu S, Liu P, Fu W, Dong Z. The peripheral blood mononuclear cells versus purified CD34+ cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis-a randomized single-blinded non-inferiority trial. Stem Cell Res Ther. 2022 Mar 21;13(1):116. doi: 10.1186/s13287-022-02804-4.
Liu H, Pan T, Fang Y, Fang G, Liu Y, Jiang X, Chen B, Wei Z, Gu S, Liu P, Fu W, Dong Z. Three-year outcomes of peripheral blood mononuclear cells vs purified CD34+ cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial. Stem Cells Transl Med. 2021 May;10(5):647-659. doi: 10.1002/sctm.20-0033. Epub 2021 Jan 5.
Dong Z, Pan T, Fang Y, Wei Z, Gu S, Fang G, Liu Y, Luo Y, Liu H, Zhang T, Hu M, Guo D, Xu X, Chen B, Jiang J, Yang J, Shi Z, Zhu T, Shi Y, Liu P, Fu W. Purified CD34+ cells versus peripheral blood mononuclear cells in the treatment of angiitis-induced no-option critical limb ischaemia: 12-Month results of a prospective randomised single-blinded non-inferiority trial. EBioMedicine. 2018 Sep;35:46-57. doi: 10.1016/j.ebiom.2018.08.038. Epub 2018 Aug 29.
Other Identifiers
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B2014-021
Identifier Type: -
Identifier Source: org_study_id
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