drugset / Trial / NCT00539266
Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The investigators propose confirm and extend the findings of open studies on the apparent efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.
Timeline
- Start
- 2007-10
- Primary completion
- 2012-10
- Completion
- 2012-10
Publications
- Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.
- Lindeman JHN, Zwaginga JJ, Kallenberg-Lantrua G, van Wissen RC, Schepers A, van Bockel HJ, Fibbe WE, Hamming JF. No Clinical Benefit of Intramuscular Delivery of Bone Marrow-derived Mononuclear Cells in Nonreconstructable Peripheral Arterial Disease: Results of a Phase-III Randomized-controlled Trial. Ann Surg. 2018 Nov;268(5):756-761. doi: 10.1097/SLA.0000000000002896.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bone Marrow Derived Mononuclear Cells | Cell therapy | 1e+09 cells | Intramuscular |
| Comparator | Bone Marrow Derived Mononuclear Cells | Cell therapy | 8e+09 cells | Intramuscular |