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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral blood mononuclear cells in treatment of critical limb ischemia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous purified CD34+ cell | Experimental | transplantation of autologous purified CD34+ cell |
|
| autologous PB-MNC | Active Comparator | transplantation of autologous peripheral blood mononuclear cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous purified CD34+ cells | Other |
| ||
| autologous peripheral blood mononuclear cells |
| Measure | Description | Time Frame |
|---|---|---|
| major-amputation-free survival rate | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| improvement on transcutaneous partial oxygen pressure | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| improvement on peak pain-free walking time | at 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihui Dong, M.D. | Contact | 862164041990 | 2904 | dzh926@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiguo Fu, M.D. | Fudan University | Study Director |
| Zhihui Dong, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhihui Dong | Recruiting | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23611711 | Background | Dong Z, Chen B, Fu W, Wang Y, Guo D, Wei Z, Xu X, Mendelsohn FO. Transplantation of purified CD34+ cells in the treatment of critical limb ischemia. J Vasc Surg. 2013 Aug;58(2):404-411.e3. doi: 10.1016/j.jvs.2013.01.037. Epub 2013 Apr 21. | |
| 35313967 | Derived | Liu H, Pan T, Liu Y, Fang Y, Fang G, Jiang X, Chen B, Wei Z, Gu S, Liu P, Fu W, Dong Z. The peripheral blood mononuclear cells versus purified CD34+ cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis-a randomized single-blinded non-inferiority trial. Stem Cell Res Ther. 2022 Mar 21;13(1):116. doi: 10.1186/s13287-022-02804-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| 33399273 | Derived | Liu H, Pan T, Fang Y, Fang G, Liu Y, Jiang X, Chen B, Wei Z, Gu S, Liu P, Fu W, Dong Z. Three-year outcomes of peripheral blood mononuclear cells vs purified CD34+ cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial. Stem Cells Transl Med. 2021 May;10(5):647-659. doi: 10.1002/sctm.20-0033. Epub 2021 Jan 5. |
| 30172703 | Derived | Dong Z, Pan T, Fang Y, Wei Z, Gu S, Fang G, Liu Y, Luo Y, Liu H, Zhang T, Hu M, Guo D, Xu X, Chen B, Jiang J, Yang J, Shi Z, Zhu T, Shi Y, Liu P, Fu W. Purified CD34+ cells versus peripheral blood mononuclear cells in the treatment of angiitis-induced no-option critical limb ischaemia: 12-Month results of a prospective randomised single-blinded non-inferiority trial. EBioMedicine. 2018 Sep;35:46-57. doi: 10.1016/j.ebiom.2018.08.038. Epub 2018 Aug 29. |
| ID | Term |
|---|---|
| D013919 | Thromboangiitis Obliterans |
| D001167 | Arteritis |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014657 | Vasculitis |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided