Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pusan National University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Adipose Tissue derived MSCs Transplantation | Procedure | Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Digital subtraction angiography (DSA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Han Cheol Lee, M.D. & Ph.D. | Pusan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Pusan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22498564 | Result | 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. 2012;76(7):1750-60. doi: 10.1253/circj.cj-11-1135. Epub 2012 Apr 12. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
| 48 weeks |
| 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 |
| 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 |
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |