NCT02089828

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

March 14, 2014

Last Update Submit

April 16, 2016

Conditions

Thromboangiitis ObliteransArteritisPeripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • major-amputation-free survival rate

    at 6 months

Secondary Outcomes (1)

  • improvement on transcutaneous partial oxygen pressure

    at 3 months

Other Outcomes (1)

  • improvement on peak pain-free walking time

    at 3 months

Study Arms (2)

autologous purified CD34+ cell

EXPERIMENTAL

transplantation of autologous purified CD34+ cell

Other: autologous purified CD34+ cells

autologous PB-MNC

ACTIVE COMPARATOR

transplantation of autologous peripheral blood mononuclear cells

Other: autologous peripheral blood mononuclear cells

Interventions

autologous purified CD34+ cellsOTHER
autologous purified CD34+ cell
autologous peripheral blood mononuclear cellsOTHER
autologous PB-MNC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • within 3 months of an acute myocardial infarction
  • any contraindication for the administration of granulocyte colony stimulating factor (G-CSF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhihui Dong

Shanghai, 200032, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23611711BACKGROUND

  • Liu H, Pan T, Liu Y, Fang Y, Fang G, Jiang X, Chen B, Wei Z, Gu S, Liu P, Fu W, Dong Z. The peripheral blood mononuclear cells versus purified CD34+ cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis-a randomized single-blinded non-inferiority trial. Stem Cell Res Ther. 2022 Mar 21;13(1):116. doi: 10.1186/s13287-022-02804-4.

    PMID: 35313967DERIVED

  • Liu H, Pan T, Fang Y, Fang G, Liu Y, Jiang X, Chen B, Wei Z, Gu S, Liu P, Fu W, Dong Z. Three-year outcomes of peripheral blood mononuclear cells vs purified CD34+ cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial. Stem Cells Transl Med. 2021 May;10(5):647-659. doi: 10.1002/sctm.20-0033. Epub 2021 Jan 5.

    PMID: 33399273DERIVED

  • Dong Z, Pan T, Fang Y, Wei Z, Gu S, Fang G, Liu Y, Luo Y, Liu H, Zhang T, Hu M, Guo D, Xu X, Chen B, Jiang J, Yang J, Shi Z, Zhu T, Shi Y, Liu P, Fu W. Purified CD34+ cells versus peripheral blood mononuclear cells in the treatment of angiitis-induced no-option critical limb ischaemia: 12-Month results of a prospective randomised single-blinded non-inferiority trial. EBioMedicine. 2018 Sep;35:46-57. doi: 10.1016/j.ebiom.2018.08.038. Epub 2018 Aug 29.

    PMID: 30172703DERIVED

MeSH Terms

Conditions

Thromboangiitis ObliteransArteritisPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesVasculitisAtherosclerosisArteriosclerosisPeripheral Vascular Diseases

Study Officials

  • Weiguo Fu, M.D.

    Fudan University

    STUDY DIRECTOR

  • Zhihui Dong, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihui Dong, M.D.

CONTACT

862164041990dzh926@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 18, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CN(1)