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Clinical Trials/NCT02089828
NCT02089828UnknownNot Applicable

Randomized Control Trial on Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia

Shanghai Zhongshan Hospital1 site in 1 country50 target enrollmentStarted: March 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
major-amputation-free survival rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

autologous purified CD34+ cell

Experimental

transplantation of autologous purified CD34+ cell

Intervention: autologous purified CD34+ cells (Other)

autologous PB-MNC

Active Comparator

transplantation of autologous peripheral blood mononuclear cells

Intervention: autologous peripheral blood mononuclear cells (Other)

Outcomes

Primary Outcomes

major-amputation-free survival rate

Time Frame: at 6 months

Secondary Outcomes

  • improvement on transcutaneous partial oxygen pressure(at 3 months)

Investigators

Sponsor
Shanghai Zhongshan Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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