Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia

R-Bio1 site in 1 country20 target enrollmentJanuary 2009

ConditionsCritical Limb Ischemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Limb Ischemia
Sponsor: R-Bio
Enrollment: 20
Locations: 1
Primary Endpoint: Major Adverse Events Analysis (MAEs)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

April 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

R-Bio

Responsible Party

Sponsor

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