NCT01408381

Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI).

Multicenter Phase II, Randomized Open Clinical Trial on the Therapeutic Use of Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Chronic Ischemia of Lower Limbs (CLI).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three levels of dose. The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide progenitor cells with regenerative capacity and besides secrete several angiogenic factors, and their implantation into ischemic tissues with both elements should contribute to angiogenesis and tissue regeneration with recovery of the circulation in the affected limb.

Detailed description

The study population will consist of a total of 44 non-diabetic patients with chronic critical ischemia in at least one of their lower limbs (CLI) and without possibility of revascularization. In the experimental group will be included a total of 33 patients divided into three levels of dose, 11 patients in each level (increasing dose of mononuclear cells from autologous bone marrow) and other 11 patients in control group. * 11 patients in group 1 will not receive cell therapy, and they will only receive conventional treatment, acting as a control group. * 11 patients in group 2 will receive 1x108 autologous bone marrow mononuclear cells. * 11 patients in group 3 will receive 5x108 autologous bone marrow mononuclear cells. * 11 patients in group 4 will receive 1x109 autologous bone marrow mononuclear cells. The cell therapy drug will be administered intra-arterially in all cases. Patients will be evaluated by clinical, radiological and angiological methods (ankle / brachial pressure index, transcutaneous oxygen pressure, perimeter calf muscle, presence of ulcers, oximetry and digital arteriography). Patients will receive concomitant drug treatment established by the good clinical practice, so undoubtedly it could be possible that some improvement occurs due to drug treatment. It is estimated that the inclusion period is approximately 42 months, and the follow-up of each patient of six months. Therefore the total duration of the study will be about forty eight months from the entry of the first patient to the end of the follow-up period of the last patient included. The primary variable is the improvement in the vascularisation of the treated limb determined by clinical, angiographic and angiologist parameters. Study objectives : • Main objective: To evaluate the safety and feasibility of the autotransplantation of autologous bone marrow mononuclear cells administered intra-arterially in non-diabetic patients with critical chronic ischemia of the lower limbs without possibility of either revascularization or other therapeutic alternatives. Secondary objectives: 1. To compare the effect of three increasing dose of mononuclear cells from autologous bone marrow in the recovery of clinical, angiographic angiologist parameters in non-diabetic patients with critical chronic ischemia of lower limbs to a control group that will have been applied to a conventional treatment. 2. To analyze complications from regenerative therapy itself, from the route of administration and / or study procedures.

Conditions

• Critical Limb Ischemia (CLI)

Interventions

Type	Name	Description
OTHER	Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells	Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x108, 5x108 and 1x109 low, intermediate and high dose in the arms respectively.

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2011-08-03
• Last updated: 2016-03-16

Locations

5 sites across 1 country: Spain