Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia
Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 8, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedJune 5, 2019
June 1, 2019
1.2 years
August 8, 2012
June 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
48 weeks
Secondary Outcomes (5)
Ankle-Brachial Index (ABI)
48 weeks
Digital subtraction angiography (DSA)
48 weeks
Thermography
48 weeks
Wong-Baker FACES Pain Rating Score
48 weeks
Treadmill test
48 weeks
Interventions
Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 \~3x10e8 cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Biolead
- Pusan National University Hospitalcollaborator
Study Sites (1)
Pusan National University Hospital
Pusan, South Korea
Related Publications (1)
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.
PMID: 22498564RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han Cheol Lee, M.D. & Ph.D.
Pusan National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2012
First Posted
August 13, 2012
Study Start
January 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2011
Last Updated
June 5, 2019
Record last verified: 2019-06