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

April 16, 2016 updated by: Shanghai Zhongshan Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Zhihui Dong
        • Contact:
          • Zhihui Dong, M.D.
          • Phone Number: 2904 862164041990
          • Email: dzh926@126.com
        • Principal Investigator:
          • Weiguo Fu, M.D.
        • Principal Investigator:
          • Zhihui Dong, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous purified CD34+ cell
transplantation of autologous purified CD34+ cell
Other: autologous purified CD34+ cells
Active Comparator: autologous PB-MNC
transplantation of autologous peripheral blood mononuclear cells
Other: autologous peripheral blood mononuclear cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
major-amputation-free survival rate
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement on transcutaneous partial oxygen pressure
Time Frame: at 3 months
at 3 months

Other Outcome Measures

Outcome Measure
Time Frame
improvement on peak pain-free walking time
Time Frame: at 3 months
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Director: Weiguo Fu, M.D., Fudan University
  • Principal Investigator: Zhihui Dong, M.D., Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 16, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2014-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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