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

Biostar Stem Cell Research Institute (R-Bio)

Status

Completed

Conditions

Critical Limb Ischemia

Treatments

Procedure: Autologous Adipose Tissue derived MSCs Transplantation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01663376

KSC-MSCs-CLI

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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