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Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell

Primary Purpose

Ischemia

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell

About this trial

This is an interventional supportive care trial for Ischemia focused on measuring Safety and efficiency of angiogenesis for patients with limb, ischemia by transplantation of human cord blood mononuclear, cells

Eligibility Criteria

undefined - 60 Years (Child, Adult)All Sexes

Inclusion Criteria:Patients with ischemic symptoms such as claudication, rest pain or nonhealing ischemic wound

Without evidence of improvement in response to conventional medical therapy
Not candidates for surgical intervention or radiologic intervention

Exclusion Criteria:

Malignant disease
More than 60 years old
Other significant medical conditions, including diabetes mellitus, hypertension, hyperlipidemia, etc.

Sites / Locations

Samsung Medical Center, Sungkyunkwan University School of MedicineRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00518934

First Posted

August 19, 2007

Last Updated

August 20, 2007

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00518934

Brief Title

Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Samsung Medical Center

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemia

Keywords

Safety and efficiency of angiogenesis for patients with limb, ischemia by transplantation of human cord blood mononuclear, cells

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell

10. Eligibility

Sex

All

Maximum Age & Unit of Time

60 Years

Eligibility Criteria

Inclusion Criteria:Patients with ischemic symptoms such as claudication, rest pain or nonhealing ischemic wound Without evidence of improvement in response to conventional medical therapy Not candidates for surgical intervention or radiologic intervention Exclusion Criteria: Malignant disease More than 60 years old Other significant medical conditions, including diabetes mellitus, hypertension, hyperlipidemia, etc.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong-Ik Kim, Professor

Phone

82-2-3410-3467

dikim@skku.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong-Ik Kim, Professor

Organizational Affiliation

Professor of division of vascular surgery, Samsung Medical Center, Sungkyunkwan University of School of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Samsung Medical Center, Sungkyunkwan University School of Medicine

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong-Ik Kim, Professor

Phone

82-2-3410-3467

dikim@skku.edu

12. IPD Sharing Statement

Citations:

PubMed Identifier

16439614

Citation

Kim DI, Kim MJ, Joh JH, Shin SW, Do YS, Moon JY, Kim NR, Lim JE, Kim AK, Eo HS, Kim BS, Cho SW, Yang SH, Park CJ, Shim JS. Angiogenesis facilitated by autologous whole bone marrow stem cell transplantation for Buerger's disease. Stem Cells. 2006 May;24(5):1194-200. doi: 10.1634/stemcells.2005-0349. Epub 2006 Jan 26.

Results Reference

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Learn more about this trial

Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell

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