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Clinical Trial: TACT-NAGOYA

This study is currently recruiting patients.
Verified by Nagoya University August 2003

Sponsored by: Nagoya University
Information provided by: Nagoya University
ClinicalTrials.gov Identifier: NCT00145262

Purpose

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 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 potential limiting factor which reduce the efficacy of TACT
Condition Intervention Phase
Buerger Disease
arteriosclerosis obliterans (ASO)
Ischemic ulcers
  Procedure: Autologous Bone Marrow Mononuclear Cell Implantation
 Phase II

MedlinePlus related topics:  Skin Conditions;   Vascular Diseases;   Vasculitis

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya

Further Study Details: 

Study start: August 2003

Eligibility

Ages Eligible for Study:  20 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Subjects who has 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 (HbA1c >6•5% and proliferative retinopathy)
  • Evidence of malignant disorder during the past 5 years
  • Subjects who can not survive more than 1 year with other complications
  • Malignant Rheumatic Arthritis

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00145262

Murohara Toyoaki      81-52-744-2149    murohara@med.nagoya-u.ac.jp

Japan
      Department of Cardiology, Nagoya Univesity Graduate School of Medicine, Nagoya,  466-8550,  Japan; Recruiting
Toyoaki Murohara, MD, PhD  81-52-744-2149    murohara@med.nagoya-u.ac.jp 

Study chairs or principal investigators

Toyoaki Murohara, MD, PhD,  Principal Investigator,  Department of Cardiology, Nagoya University Graduate School od Medicine   

More Information

Publications

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.

Study ID Numbers:  66
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00145262
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-06


Source: ClinicalTrials.gov
Cache Date: September 7, 2005

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Page Updated: December 9, 2005
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