TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

• Conditions: Buerger Disease; Arteriosclerosis Obliterans

• Registration Number: NCT00145262
• Lead Sponsor: Nagoya University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2003-08
• Study Start: 2003-08
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Last Update Submitted: 2005-12-29
• Last Update Posted: 2005-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Department of Cardiology, Nagoya University Graduate School of Medicine; 🇯🇵 Nagoya, Japan