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TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145262
Recruitment Status : Unknown
Verified August 2003 by Nagoya University.
Recruitment status was:  Recruiting
First Posted : September 5, 2005
Last Update Posted : December 30, 2005
Information provided by:
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).

Condition or disease Intervention/treatment
Buerger Disease Arteriosclerosis Obliterans Procedure: Autologous Bone Marrow Mononuclear Cell Implantation

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Study Type : Observational
Observational Model: Defined Population
Time Perspective: Prospective
Official Title: Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya
Study Start Date : August 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145262

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Contact: Murohara Toyoaki 81-52-744-2149

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Department of Cardiology, Nagoya University Graduate School of Medicine Recruiting
Nagoya, Japan, 466-8550
Contact: Toyoaki Murohara, MD, PhD    81-52-744-2149   
Sponsors and Collaborators
Nagoya University
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Principal Investigator: Toyoaki Murohara, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00145262    
Other Study ID Numbers: 66
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 30, 2005
Last Verified: August 2003
Keywords provided by Nagoya University:
critical limb ischemia
bone marrow mononuclear cells
Arteriosclerosis Obliterans (ASO)
Ischemic ulcers
Additional relevant MeSH terms:
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Thromboangiitis Obliterans
Arteriosclerosis Obliterans
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases