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

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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

Trial contacts and locations

0

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Central trial contact

Zhihui Dong, M.D.

Data sourced from clinicaltrials.gov

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