TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

Arteriosclerosis Obliterans Clinical Trial

Official title:

Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00145262
• Other study ID #: 66
• Status: Recruiting
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: December 29, 2005
• Start date: August 2003

Study information

• Verified date: August 2003
• Source: Nagoya University
• Contact: Murohara Toyoaki
• Phone: 81-52-744-2149
• Email: murohara[@]med.nagoya-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis Obliterans
• Buerger Disease
• Thromboangiitis Obliterans

Intervention

Procedure:
• Autologous Bone Marrow Mononuclear Cell Implantation

Locations

Country	Name	City	State
Japan	Department of Cardiology, Nagoya University Graduate School of Medicine	Nagoya

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. — View Citation