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

Not Applicable

Completed

• Conditions: Critical Limb Ischemia

• Registration Number: NCT01663376
• Lead Sponsor: R-Bio

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-03
• Study Completion: 2011-04
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-13
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of