Critical Limb Ischemia
Conditions
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
Interventions
Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 \ 3x10e8 cells
Sponsors
Pusan National University Hospital
R-Bio
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events Analysis (MAEs) | 48 weeks | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle-Brachial Index (ABI) | 48 weeks | 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) | 48 weeks | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs. |
| Thermography | 48 weeks | 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 | 48 weeks | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs. |
| Treadmill test | 48 weeks | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs. |
Countries
South Korea
Outcome results
None listed