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

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

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 Type

Interventional


Primary Outcome

major-amputation-free survival rate

Secondary Outcome

 improvement on transcutaneous partial oxygen pressure

Condition

Thromboangiitis Obliterans

Intervention

autologous purified CD34+ cells

Study Arms / Comparison Groups

 autologous purified CD34+ cell
Description:  transplantation of autologous purified CD34+ cell

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

50

Start Date

March 2014

Completion Date

December 2018

Primary Completion Date

December 2017

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)
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Weiguo Fu, M.D., 862164041990, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02089828

Organization ID

B2014-021


Responsible Party

Sponsor

Study Sponsor

Shanghai Zhongshan Hospital


Study Sponsor

Weiguo Fu, M.D., Study Director, Fudan University


Verification Date

April 2016