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

Fudan University

Status: Unknown

Conditions: Arteritis; Peripheral Arterial Disease; Thromboangiitis Obliterans

Treatments: Other: autologous purified CD34+ cells; Other: autologous peripheral blood mononuclear cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02089828

B2014-021

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

autologous purified CD34+ cell

Experimental group

Description:

transplantation of autologous purified CD34+ cell

Treatment:

Other: autologous purified CD34+ cells

autologous PB-MNC

Active Comparator group

Description:

transplantation of autologous peripheral blood mononuclear cells

Treatment:

Other: autologous peripheral blood mononuclear cells