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TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2003 by Nagoya University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145262
First Posted: September 5, 2005
Last Update Posted: December 30, 2005
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.
Information provided by:
Nagoya University
  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, 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 Intervention Phase
Buerger Disease Arteriosclerosis Obliterans Procedure: Autologous Bone Marrow Mononuclear Cell Implantation Phase 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya

Resource links provided by NLM:


Further study details as provided by Nagoya University:

Study Start Date: August 2003
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00145262


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

Locations
Japan
Department of Cardiology, Nagoya University Graduate School of Medicine Recruiting
Nagoya, Japan, 466-8550
Contact: Toyoaki Murohara, MD, PhD    81-52-744-2149    murohara@med.nagoya-u.ac.jp   
Sponsors and Collaborators
Nagoya University
Investigators
Principal Investigator: Toyoaki Murohara, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00145262     History of Changes
Other Study ID Numbers: 66
First Submitted: September 2, 2005
First Posted: September 5, 2005
Last Update Posted: December 30, 2005
Last Verified: August 2003

Keywords provided by Nagoya University:
critical limb ischemia
bone marrow mononuclear cells
angiogenesis
vasculogenesis
Arteriosclerosis Obliterans (ASO)
Ischemic ulcers

Additional relevant MeSH terms:
Arteriosclerosis
Thromboangiitis Obliterans
Arteriosclerosis Obliterans
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis