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TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2003 by Nagoya University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nagoya University
ClinicalTrials.gov Identifier:
NCT00145262
First received: September 2, 2005
Last updated: December 29, 2005
Last verified: August 2003
History of Changes
  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

Further study details as provided by Nagoya University:

Study Start Date: August 2003
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00145262     History of Changes
Other Study ID Numbers: 66
Study First Received: September 2, 2005
Last Updated: December 29, 2005
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on May 22, 2013