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

Not Applicable

• Conditions: Arteritis; Peripheral Arterial Disease; Thromboangiitis Obliterans
• Interventions: Other: autologous purified CD34+ cells; Other: autologous peripheral blood mononuclear cells

• Registration Number: NCT02089828
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-16
• Last Update Posted: 2016-04-19
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autologous purified CD34+ cell	autologous purified CD34+ cells	transplantation of autologous purified CD34+ cell
autologous PB-MNC	autologous peripheral blood mononuclear cells	transplantation of autologous peripheral blood mononuclear cells

Primary Outcome Measures

Name	Time	Method
major-amputation-free survival rate	at 6 months

Secondary Outcome Measures

Name	Time	Method
improvement on transcutaneous partial oxygen pressure	at 3 months

Trial Locations

Locations (1)

Zhihui Dong; 🇨🇳 Shanghai, China