TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

T

Tokai National Higher Education and Research System

Status

Unknown

Conditions

Buerger Disease
Arteriosclerosis Obliterans

Treatments

Procedure: Autologous Bone Marrow Mononuclear Cell Implantation

Study type

Observational

Funder types

Other

Identifiers

NCT00145262
66

Details and patient eligibility

About

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).

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Murohara Toyoaki

Data sourced from clinicaltrials.gov

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