TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

Brief Title

TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

Official Title

Therapeutic Angiogenesis Using Cell Transplantation (TACT) Study at Nagoya

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).
    



Study Type

Observational




Condition

Buerger Disease

Intervention

Autologous Bone Marrow Mononuclear Cell Implantation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure


Start Date

August 2003



Eligibility 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
      

Gender

All

Ages

20 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Toyoaki Murohara, MD, PhD, 81-52-744-2149, [email protected]

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT00145262

Organization ID

66



Study Sponsor

Nagoya University


Study Sponsor

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


Verification Date

August 2003