TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

Tokai National Higher Education and Research System

Status: Unknown

Conditions: Buerger Disease; Arteriosclerosis Obliterans

Treatments: Procedure: Autologous Bone Marrow Mononuclear Cell Implantation

Study type: Observational

Funder types: Other

Identifiers

NCT00145262

66

Details and patient eligibility

About

Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation. We, the investigators at Nagoya University, further investigated the efficacy and safety of autologous implantation of BM-MNCs or PB-MNCs in patients with severe ischaemic limbs who have no other alternative therapeutic options. We also examined a potential limiting factor which reduced the efficacy of therapeutic angiogenesis using cell transplantation (TACT).

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have chronic limb ischemia, including rest pain, non-healing ischemic ulcers, or both, and who are not candidates for nonsurgical or surgical revascularisation.

Exclusion criteria

• Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 6.5% and proliferative retinopathy)
• Evidence of malignant disorder during the past 5 years
• Subjects who cannot survive more than 1 year with other complications
• Malignant rheumatic arthritis