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NCT02089828 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02089828
Other study ID # B2014-021
Secondary ID
Status Recruiting
Phase N/A
First received March 14, 2014
Last updated April 16, 2016
Start date March 2014
Est. completion date December 2018

Study information
Verified date April 2016
Source Shanghai Zhongshan Hospital
Contact Zhihui Dong, M.D.
Phone 862164041990
Email dzh926@126.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• autologous purified CD34+ cells

• autologous peripheral blood mononuclear cells

Locations
Country Name City State
China Zhihui Dong Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Dong Z, Chen B, Fu W, Wang Y, Guo D, Wei Z, Xu X, Mendelsohn FO. Transplantation of purified CD34+ cells in the treatment of critical limb ischemia. J Vasc Surg. 2013 Aug;58(2):404-411.e3. doi: 10.1016/j.jvs.2013.01.037. Epub 2013 Apr 21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other improvement on peak pain-free walking time at 3 months No
Primary major-amputation-free survival rate at 6 months No
Secondary improvement on transcutaneous partial oxygen pressure at 3 months No
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