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Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia

Primary Purpose

Critical Limb Ischemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous Adipose Tissue derived MSCs Transplantation
Sponsored by
R-Bio
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 6 months since the onset CLI(Chronic ASO or Buerger disease)
  • Patients with luminal stenosis > 50% by leg angiography
  • Age is between 20 and 80
  • Patients whose Rutherford's class is II-4, III-5 or III-6 (Patients with rest pain or ischemic ulcer/necrosis)
  • Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization
  • Patients who can give informed consent themselves in writing

Exclusion Criteria:

  • Previous or current history of neoplasm or comorbidity that could impact the patient's survival
  • Detection of proximal source of emboli including atrial fibrillation
  • Primary hematologic disease, including hypercoagulable states
  • Detection of proliferative retinopathy
  • Entrapment syndrome
  • Alcohol abuse, cocaine amphetamine etc.
  • Detection of osteomyelitis
  • Uncontrolled DM

Sites / Locations

  • Pusan National University Hospital

Outcomes

Primary Outcome Measures

Major Adverse Events Analysis (MAEs)
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs

Secondary Outcome Measures

Ankle-Brachial Index (ABI)
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Digital subtraction angiography (DSA)
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Thermography
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Wong-Baker FACES Pain Rating Score
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Treadmill test
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.

Full Information

First Posted
August 8, 2012
Last Updated
June 3, 2019
Sponsor
R-Bio
Collaborators
Pusan National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01663376
Brief Title
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia
Official Title
Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
Collaborators
Pusan National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Autologous Adipose Tissue derived MSCs Transplantation
Intervention Description
Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells
Primary Outcome Measure Information:
Title
Major Adverse Events Analysis (MAEs)
Description
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Ankle-Brachial Index (ABI)
Description
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time Frame
48 weeks
Title
Digital subtraction angiography (DSA)
Description
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time Frame
48 weeks
Title
Thermography
Description
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time Frame
48 weeks
Title
Wong-Baker FACES Pain Rating Score
Description
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time Frame
48 weeks
Title
Treadmill test
Description
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 6 months since the onset CLI(Chronic ASO or Buerger disease) Patients with luminal stenosis > 50% by leg angiography Age is between 20 and 80 Patients whose Rutherford's class is II-4, III-5 or III-6 (Patients with rest pain or ischemic ulcer/necrosis) Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization Patients who can give informed consent themselves in writing Exclusion Criteria: Previous or current history of neoplasm or comorbidity that could impact the patient's survival Detection of proximal source of emboli including atrial fibrillation Primary hematologic disease, including hypercoagulable states Detection of proliferative retinopathy Entrapment syndrome Alcohol abuse, cocaine amphetamine etc. Detection of osteomyelitis Uncontrolled DM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Cheol Lee, M.D. & Ph.D.
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22498564
Citation
Lee HC, An SG, Lee HW, Park JS, Cha KS, Hong TJ, Park JH, Lee SY, Kim SP, Kim YD, Chung SW, Bae YC, Shin YB, Kim JI, Jung JS. Safety and effect of adipose tissue-derived stem cell implantation in patients with critical limb ischemia: a pilot study. Circ J. 2012;76(7):1750-60. doi: 10.1253/circj.cj-11-1135. Epub 2012 Apr 12.
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Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia

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