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

Critical Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663376
• Other study ID #: KSC-MSCs-CLI
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2019
• Source: R-Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Procedure:
• Autologous Adipose Tissue derived MSCs Transplantation
Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Pusan

Sponsors (2)

Lead Sponsor	Collaborator
R-Bio	Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ankle-Brachial Index (ABI)	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	Digital subtraction angiography (DSA)	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	Thermography	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	Wong-Baker FACES Pain Rating Score	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	Treadmill test	To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.	48 weeks