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

Primary Purpose

Thromboangiitis Obliterans, Arteritis, Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
autologous purified CD34+ cells
autologous peripheral blood mononuclear cells
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thromboangiitis Obliterans

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Zhihui DongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

autologous purified CD34+ cell

autologous PB-MNC

Arm Description

transplantation of autologous purified CD34+ cell

transplantation of autologous peripheral blood mononuclear cells

Outcomes

Primary Outcome Measures

major-amputation-free survival rate

Secondary Outcome Measures

improvement on transcutaneous partial oxygen pressure

Full Information

First Posted
March 14, 2014
Last Updated
April 16, 2016
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02089828
Brief Title
Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia
Official Title
Randomized Control Trial on Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboangiitis Obliterans, Arteritis, Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
autologous purified CD34+ cell
Arm Type
Experimental
Arm Description
transplantation of autologous purified CD34+ cell
Arm Title
autologous PB-MNC
Arm Type
Active Comparator
Arm Description
transplantation of autologous peripheral blood mononuclear cells
Intervention Type
Other
Intervention Name(s)
autologous purified CD34+ cells
Intervention Type
Other
Intervention Name(s)
autologous peripheral blood mononuclear cells
Primary Outcome Measure Information:
Title
major-amputation-free survival rate
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
improvement on transcutaneous partial oxygen pressure
Time Frame
at 3 months
Other Pre-specified Outcome Measures:
Title
improvement on peak pain-free walking time
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihui Dong, M.D.
Phone
862164041990
Ext
2904
Email
dzh926@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiguo Fu, M.D.
Organizational Affiliation
Fudan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhihui Dong, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhihui Dong
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihui Dong, M.D.
Phone
862164041990
Ext
2904
Email
dzh926@126.com
First Name & Middle Initial & Last Name & Degree
Weiguo Fu, M.D.
First Name & Middle Initial & Last Name & Degree
Zhihui Dong, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
23611711
Citation
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.
Results Reference
background
PubMed Identifier
35313967
Citation
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.
Results Reference
derived
PubMed Identifier
33399273
Citation
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.
Results Reference
derived
PubMed Identifier
30172703
Citation
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.
Results Reference
derived

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

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